Glucose in Well Babies Steering Committee
-1080135-114300000Glucose in Well Babies Steering CommitteeDr Deborah Harris (Chair)Dr Phil WestonDistinguished Professor Jane HardingCo-ordinating CentreWaikato HospitalPrivate Bag 3200Hamilton New ZealandEmail: Deborah.Harris@waikatodhb.health.nzVersion recordDateVersionUpdates20 June 2015V. 1Working copy for funding and registration applications3 September 2015V. 2Changes included Eligibility criteria to exclude multiplesGrowth charts changed from the International INTERGROWTH chartsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WaWxsYXI8L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 1 to The Australian Fenton Charts ADDIN EN.CITE <EndNote><Cite><Author>Fenton</Author><Year>2003</Year><RecNum>937</RecNum><DisplayText><style face="superscript">2</style></DisplayText><record><rec-number>937</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420597689">937</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Fenton, T R</author></authors></contributors><auth-address>Department of Community Health Sciences, Faculty of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta, T2N 4N1, Canada. tanisfenton@shaw.ca</auth-address><titles><title>A new growth chart for preterm babies: Babson and Benda's chart updated with recent data and a new format</title><secondary-title>BMC Pediatrics</secondary-title><alt-title>BMC Pediatr</alt-title></titles><periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></periodical><alt-periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></alt-periodical><pages>13</pages><volume>3</volume><keywords><keyword>*Anthropometry</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Infant, Premature/*growth & development</keyword></keywords><dates><year>2003</year><pub-dates><date>Dec 16</date></pub-dates></dates><isbn>1471-2431 (Electronic)
1471-2431 (Linking)</isbn><accession-num>14678563</accession-num><urls><related-urls><url> Table of Contents TOC \o "1-3" \h \z \u Co-ordinating Centre PAGEREF _Toc299355928 \h 1Version record PAGEREF _Toc299355929 \h 2Glucose in Well Babies Study - GLOW PAGEREF _Toc299355930 \h 4Project Summary PAGEREF _Toc299355931 \h 4Aims PAGEREF _Toc299355932 \h 5Research outcome PAGEREF _Toc299355933 \h 5Specific aims PAGEREF _Toc299355934 \h 5Background and rationale PAGEREF _Toc299355935 \h 5Blood glucose screening PAGEREF _Toc299355936 \h 6Alternative cerebral fuels PAGEREF _Toc299355937 \h 6Feeding PAGEREF _Toc299355938 \h 7Research Plan PAGEREF _Toc299355939 \h 8Study design PAGEREF _Toc299355940 \h 8Study Setting PAGEREF _Toc299355941 \h 8Study population PAGEREF _Toc299355942 \h 8Recruitment PAGEREF _Toc299355943 \h 8Informed Consent PAGEREF _Toc299355944 \h 8Withdrawal from the Study PAGEREF _Toc299355945 \h 9Study Procedures (Appendix 1) PAGEREF _Toc299355946 \h 9Daily plan and review PAGEREF _Toc299355947 \h 9Blood glucose, lactate and beta-hydroxybutyrate analysis PAGEREF _Toc299355948 \h 9Sampling and Timing of the blood samples PAGEREF _Toc299355949 \h 9Continuous interstitial glucose monitor PAGEREF _Toc299355950 \h 10Feeding data PAGEREF _Toc299355951 \h 10Health information data PAGEREF _Toc299355952 \h 10Follow up PAGEREF _Toc299355953 \h 10Adverse events PAGEREF _Toc299355954 \h 10Power and Sample size PAGEREF _Toc299355955 \h 11Data Analysis PAGEREF _Toc299355956 \h 11Data security PAGEREF _Toc299355957 \h 12Significance PAGEREF _Toc299355958 \h 12Project Management PAGEREF _Toc299355959 \h 13Trial Duration PAGEREF _Toc299355960 \h 13Ethics PAGEREF _Toc299355961 \h 13Funding PAGEREF _Toc299355962 \h 13Trial Registration PAGEREF _Toc299355963 \h 13Dissemination of results PAGEREF _Toc299355964 \h 13References PAGEREF _Toc299355965 \h 14Glucose in Well Babies Study - GLOWProject SummaryNeonatal hypoglycaemia is important because it is common and linked with brain injury and poor neurological outcome. In recent years, there has been considerable interest in the detection and management of neonatal hypoglycaemia. Babies who are identified as being at risk are screened using heel-prick blood tests for the first days after birth. If hypoglycaemia is diagnosed, then treatment is usually provided. Glucose is the primary cerebral fuel and the aim of treatment is to increase the blood glucose concentration to ensure adequate cerebral energy supply. The definition of neonatal hypoglycaemia has caused considerable controversy. The current widely accepted definition of < 2.6mM has been determined using limited, but the only available data. However, the normal glucose profile of healthy appropriately grown term newborns has never been reliably described, and it is possible that many babies are being unnecessarily treated. Babies have been shown to use alternative cerebral fuels, primarily lactate and ketones, but the profiles of blood lactate and ketone concentrations in healthy newborns within the first week are also unclear.We propose a prospective observational cohort study in healthy appropriately grown term newborns to describe the normal glucose, lactate and ketone concentration profiles over the first five postnatal days. Babies enrolled in the study will be cared for as normal newborns, largely by the parents as they progress from hospital or birthing centre to home. Blood samples for analysis of glucose, lactate and ketones will be taken initially from the umbilical artery. Capillary blood tests will then be taken by heel pricks, initially matching the frequency of blood tests taken according current screening protocols for babies born at risk of neonatal hypoglycaemia, and continue for the first five postnatal days. In addition, all babies will have continuous interstitial glucose monitoring. The results of the blood and interstitial glucose measurements will not be available to clinicians caring for the baby. If “neonatal hypoglycaemia” as currently defined is shown to be common in healthy term newborns, it is possible that current clinical management of babies at risk will significantly change. AimsResearch outcomeTo describe the blood glucose, lactate and ketone concentration profiles in term, healthy, appropriately grown babies in the first five postnatal days. Specific aimsTo determinethe incidence of blood glucose concentrations < 2.6mMthe range and variation of blood and interstitial glucose concentrations the range and variation of blood lactate and ketone concentrationsthe differences, if any, between breast-fed and formula fed babies in blood glucose, lactate and ketone concentrations.Background and rationaleNeonatal hypoglycaemia is important because it is common and linked with brain injury and neurodevelopmental delay.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CdXJuczwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 3, 4 The severity, frequency and duration of hypoglycaemia required to cause brain injury remains unclear. ADDIN EN.CITE <EndNote><Cite><Author>Hay</Author><Year>2009</Year><RecNum>380</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>380</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586849">380</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hay, W W</author><author>Raju, T</author><author>Higgins, R</author><author>Kalhan, S</author><author>Devaskar, S</author></authors></contributors><titles><title>Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>612-617</pages><volume>155</volume><number>5</number><section>612</section><keywords><keyword>hypoglycaemia, fetal and neonatal glucose metabolism, brain and glucose metabolism, treatment issues</keyword></keywords><dates><year>2009</year></dates><work-type>review</work-type><urls></urls></record></Cite></EndNote>5 However, blood glucose concentrations < 2.6mM have been linked with impaired brain function and neurodevelopmental delay.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2g8L0F1dGhvcj48WWVhcj4xOTg4PC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA 8, 9 Of babies at risk, half will become hypoglycaemic within the first 48 hours after birth. ADDIN EN.CITE <EndNote><Cite><Author>Harris</Author><Year>2012</Year><RecNum>19</RecNum><DisplayText><style face="superscript">10</style></DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1378269043">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Harris, D L</author><author>Weston, P J</author><author>Harding, J E</author></authors></contributors><titles><title>Incidence of neonatal hypoglycemia in babies identified as at risk</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics </alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>787-91</pages><volume>161</volume><number>5</number><edition>23 June 2012</edition><dates><year>2012</year></dates><work-type>Observational</work-type><urls><related-urls><url> However, there is no reliable evidence describing the normal blood glucose profile in the first week after birth. ADDIN EN.CITE <EndNote><Cite><Author>Hay</Author><Year>2009</Year><RecNum>380</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>380</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586849">380</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hay, W W</author><author>Raju, T</author><author>Higgins, R</author><author>Kalhan, S</author><author>Devaskar, S</author></authors></contributors><titles><title>Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>612-617</pages><volume>155</volume><number>5</number><section>612</section><keywords><keyword>hypoglycaemia, fetal and neonatal glucose metabolism, brain and glucose metabolism, treatment issues</keyword></keywords><dates><year>2009</year></dates><work-type>review</work-type><urls></urls></record></Cite></EndNote>5Older reports have shown that blood glucose concentrations in newborn babies fall immediately after birth, reaching a nadir between 30 and 90 minutes.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TcmluaXZhc2FuPC9BdXRob3I+PFllYXI+MTk4NjwvWWVh
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ADDIN EN.CITE.DATA 11-13 Following the nadir, regardless of feeding, the blood glucose concentration increases and stabilises by between 12 to 48 hours, reaching concentrations consistent with adult glucose concentrations between days 3 and 4. ADDIN EN.CITE <EndNote><Cite><Author>Cornblath</Author><Year>1965</Year><RecNum>910</RecNum><DisplayText><style face="superscript">13</style></DisplayText><record><rec-number>910</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420256840">910</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Cornblath, M</author><author>Reisner, S H</author></authors></contributors><titles><title>Blood glucose in the neonate and its clinical significance</title><secondary-title>N Engl J Med</secondary-title><alt-title>The New England Journal of Medicine</alt-title></titles><periodical><full-title>The New England Journal Medicine</full-title><abbr-1>N Engl J Med</abbr-1></periodical><alt-periodical><full-title>The New England Journal of Medicine</full-title></alt-periodical><pages>378-81</pages><volume>273</volume><number>7</number><keywords><keyword>*Blood Glucose</keyword><keyword>Glucose/therapeutic use</keyword><keyword>Humans</keyword><keyword>Hyperglycemia/drug therapy</keyword><keyword>Hypoglycemia/drug therapy</keyword><keyword>Hypoglycemic Agents/therapeutic use</keyword><keyword>Infant, Newborn/*blood</keyword><keyword>Insulin/therapeutic use</keyword><keyword>Reference Values</keyword></keywords><dates><year>1965</year><pub-dates><date>Aug 12</date></pub-dates></dates><isbn>0028-4793 (Print)
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ADDIN EN.CITE.DATA 14 Secondly, healthy babies used to remain in hospital for up to a week after birth and the nursery protocols, rather than the baby, directed the feeding regimens. Current recommendations for newborn care differ considerably from those approaches. Mothers and babies are encouraged to establish skin-to-skin contact and breast-feeding as soon as possible after birth, ADDIN EN.CITE <EndNote><Cite><Author>American Academy of Pediatrics</Author><Year>2012</Year><RecNum>955</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>955</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420948138">955</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>American Academy of Pediatrics,</author></authors></contributors><titles><title>Breastfeeding and the Use of Human Milk</title><secondary-title>Pediatrics</secondary-title><alt-title>Pediatrics</alt-title></titles><periodical><full-title>Pediatrics</full-title><abbr-1>Pediatrics</abbr-1></periodical><alt-periodical><full-title>Pediatrics</full-title><abbr-1>Pediatrics</abbr-1></alt-periodical><pages>e827-41</pages><volume>129</volume><number>3</number><dates><year>2012</year><pub-dates><date>February 27, 2012</date></pub-dates></dates><urls><related-urls><url> babies are encouraged to feed frequently, and remain in hospital only if healthcare treatment is required.Reports regarding glucose concentrations in healthy newborns are few. Comparison between studies is difficult as some studies are cross sectional,PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXdkb248L0F1dGhvcj48WWVhcj4xOTkyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 12, 18 and one study used both methods. ADDIN EN.CITE <EndNote><Cite><Author>Srinivasan</Author><Year>1986</Year><RecNum>930</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>930</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420489446">930</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Srinivasan, G</author><author>Pildes, R S</author><author>Cattamanchi, G</author><author>Voora, S</author><author>Lilien, L D</author></authors></contributors><titles><title>Plasma glucose values in normal neonates: a new look</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>114-7</pages><volume>109</volume><number>1</number><keywords><keyword>Blood Glucose/*analysis</keyword><keyword>Cesarean Section</keyword><keyword>Delivery, Obstetric/methods</keyword><keyword>Humans</keyword><keyword>Hypoglycemia/blood/diagnosis</keyword><keyword>*Infant, Newborn</keyword><keyword>Reference Values</keyword><keyword>Time Factors</keyword></keywords><dates><year>1986</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0022-3476 (Print)
0022-3476 (Linking)</isbn><accession-num>3723230</accession-num><urls><related-urls><url> is important work. However the results are limited by the mothers all had intravenous fluids (5% dextrose and saline @ 125ml/h) during labour and more if they required C. section. All babies were admitted to the observational nursery, washed and not fed for three hours. The first part of the study is longitudinal and the remaining part is cross sectional.</research-notes></record></Cite></EndNote>11 Furthermore, all reports have used differing feeding regimes.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EaXdha2FyPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48
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ADDIN EN.CITE.DATA 11, 12, 16-18 Thus, changes in blood glucose concentrations between sampling are not captured. Hence, the current descriptions of normal glucose profiles provide only a ‘snap shot’ and the longitudinal profile remains undescribed. We have developed considerable experience using continuous glucose monitoring in babies at risk of neonatal hypoglycaemia.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJyaXM8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 20, 21 Continuous glucose monitoring is safe and reliable in at-risk babies and provides the opportunity to measure the continuous relationship between glucose concentrations and feeding even in the most fragile extremely preterm babies.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZWFyZHNhbGw8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFy
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ADDIN EN.CITE.DATA 22 There have been no reports that we are aware of using continuous glucose monitoring in healthy term newborn babies. A recent report has highlighted the need for continuous glucose monitoring data in healthy babies. ADDIN EN.CITE <EndNote><Cite><Author>Mola-Schenzle</Author><Year>2014</Year><RecNum>932</RecNum><DisplayText><style face="superscript">23</style></DisplayText><record><rec-number>932</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420584834">932</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mola-Schenzle, E</author><author>Staffler, A</author><author>Klemme, M</author><author>Pellegrini, F</author><author>Molinaro, G</author><author>Parhofer, K G</author><author>Messner, H</author><author>Schulze, A</author><author>Flemmer, A W</author></authors></contributors><auth-address>Division of Neonatology, Dr von Hauner Children's Hospital and Perinatal Center, Ludwig Maximilian University Munich-Grosshadern, Munich, Germany.
Division of Neonatology, Regional Hospital Bolzano, Bolzano, Italy.
Department of Internal Medicine, Ludwig-Maximilian-University Munich-Grosshadern, Munich, Germany.</auth-address><titles><title>Clinically stable very low birthweight infants are at risk for recurrent tissue glucose fluctuations even after fully established enteral nutrition</title><secondary-title>Arch Dis Child Fetal Neonatal Ed</secondary-title><alt-title>Archives of Disease in Childhood. Fetal and Neonatal Edition</alt-title></titles><periodical><full-title>Archives of Diseases in Childhood Fetal and Neonatal Edition</full-title><abbr-1>Arch Dis Child Fetal Neonatal Ed</abbr-1></periodical><alt-periodical><full-title>Archives of Disease in Childhood. Fetal and neonatal edition</full-title></alt-periodical><dates><year>2014</year><pub-dates><date>Nov 7</date></pub-dates></dates><isbn>1468-2052 (Electronic)
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ADDIN EN.CITE.DATA 8, 9 In most Australasian nurseries, babies at risk of hypoglycaemia are required to have three pre-feed blood glucose concentrations ≥ 2.6mM at least three hours apart, before screening is discontinued. We are unaware of any data describing blood glucose concentrations in healthy term babies at the time that at-risk babies are screened. However, there have been repeated calls from high-level research ADDIN EN.CITE <EndNote><Cite><Author>Hay</Author><Year>2009</Year><RecNum>380</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>380</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586849">380</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hay, W W</author><author>Raju, T</author><author>Higgins, R</author><author>Kalhan, S</author><author>Devaskar, S</author></authors></contributors><titles><title>Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>612-617</pages><volume>155</volume><number>5</number><section>612</section><keywords><keyword>hypoglycaemia, fetal and neonatal glucose metabolism, brain and glucose metabolism, treatment issues</keyword></keywords><dates><year>2009</year></dates><work-type>review</work-type><urls></urls></record></Cite></EndNote>5 and professional groups ADDIN EN.CITE <EndNote><Cite><Author>New Zealand College of Midwives</Author><RecNum>1038</RecNum><DisplayText><style face="superscript">24</style></DisplayText><record><rec-number>1038</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1426926531">1038</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>New Zealand College of Midwives,</author></authors></contributors><titles><title>Submission on the Draft Guidelines for the treatment of hypoglycaemia with dextrose gel, within the first 48 hours after birth in late-preterm and term infants</title></titles><pages>1-7</pages><dates><year>2015</year><pub-dates><date>Jan 15 </date></pub-dates></dates><pub-location>Christchurch, (NZ)</pub-location><urls></urls></record></Cite></EndNote>24 identifying an urgent need for these data. There may be very little difference in the measured glucose concentration between healthy term babies and those identified as being at risk for neonatal hypoglycaemia. Furthermore, there is no evidence that treating transitional hypoglycaemia improves neurological outcome in at-risk babies. ADDIN EN.CITE <EndNote><Cite><Author>Hay</Author><Year>2009</Year><RecNum>380</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>380</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586849">380</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hay, W W</author><author>Raju, T</author><author>Higgins, R</author><author>Kalhan, S</author><author>Devaskar, S</author></authors></contributors><titles><title>Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>612-617</pages><volume>155</volume><number>5</number><section>612</section><keywords><keyword>hypoglycaemia, fetal and neonatal glucose metabolism, brain and glucose metabolism, treatment issues</keyword></keywords><dates><year>2009</year></dates><work-type>review</work-type><urls></urls></record></Cite></EndNote>5 If the blood glucose concentrations are similar in babies at risk, and those not at risk, this may lead to a considerable change in the management of newborn babies in relation to hypoglycaemia. The definition of neonatal hypoglycaemia has caused considerable controversy, and the clinical significance hypoglycaemia remains unclear. ADDIN EN.CITE <EndNote><Cite><Author>Hay</Author><Year>2009</Year><RecNum>380</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>380</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586849">380</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hay, W W</author><author>Raju, T</author><author>Higgins, R</author><author>Kalhan, S</author><author>Devaskar, S</author></authors></contributors><titles><title>Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>612-617</pages><volume>155</volume><number>5</number><section>612</section><keywords><keyword>hypoglycaemia, fetal and neonatal glucose metabolism, brain and glucose metabolism, treatment issues</keyword></keywords><dates><year>2009</year></dates><work-type>review</work-type><urls></urls></record></Cite></EndNote>5 At-risk babies with a blood glucose concentration < 2.6mM are usually treated, with the aim of treatment being to reduce the risk of neurological impairment. 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ADDIN EN.CITE.DATA 16, 17, which is likely to be an underestimate due to the intermittent nature of blood glucose sampling. There are no data about the frequency, severity, and duration of low blood glucose concentrations in healthy newborns.Alternative cerebral fuelsGlucose is the primary metabolic fuel for cerebral oxidation. However, babies are known to use alternative cerebral fuels, primarily lactate and ketones. There is a paucity of data about these fuels in newborn babies ADDIN EN.CITE <EndNote><Cite><Author>Hawdon</Author><Year>1992</Year><RecNum>143</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>143</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586847">143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hawdon, J M</author><author>Ward-Platt, M P</author><author>Aynsley-Green, A</author></authors></contributors><titles><title>Patterns of metabolic adaption for preterm and term infants in the first neonatal week</title><secondary-title>Arch Dis Child Educ Pract Ed</secondary-title><alt-title>Archives of Disease in Childhood</alt-title></titles><periodical><full-title>Arch Dis Child Educ Pract Ed</full-title><abbr-1>Archives of disease in childhood. Education and practice edition</abbr-1></periodical><alt-periodical><full-title>Archives of Disease in Childhood</full-title><abbr-1>Arch Dis Childhood</abbr-1></alt-periodical><pages>357-365</pages><volume>67</volume><keywords><keyword>metabolic adaption, ketone bodies, lactate, preterm term, reference data</keyword></keywords><dates><year>1992</year></dates><urls></urls></record></Cite></EndNote>16, and even fewer reports in healthy babies. Consequently, the relationship between these fuels and cerebral function remains unclear. However, there is increasing clinical interest in alternative cerebral fuels ADDIN EN.CITE <EndNote><Cite><Author>Ward Platt</Author><Year>2015</Year><RecNum>1223</RecNum><DisplayText><style face="superscript">25</style></DisplayText><record><rec-number>1223</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1432115313">1223</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ward Platt, M </author></authors></contributors><titles><title>Lactate, glucose and the neonatal brain: it's time to challenge the paradigm</title><secondary-title>Arch Dis Child Fetal Neonatal Ed</secondary-title><alt-title>Archives of Disease in Childhood Fetal and Neonatal Ed</alt-title></titles><periodical><full-title>Archives of Diseases in Childhood Fetal and Neonatal Edition</full-title><abbr-1>Arch Dis Child Fetal Neonatal Ed</abbr-1></periodical><pages>F 96-97</pages><volume>100</volume><section>96</section><dates><year>2015</year></dates><urls></urls></record></Cite></EndNote>25, including a recent recommendation that the blood concentrations of ketone should be measured during neonatal hypoglycaemia.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaG9ybnRvbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+
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ADDIN EN.CITE.DATA 26 Therefore, there is an urgent need to describe the normal blood ketone and lactate concentrations in healthy newborns.One of the reasons for the lack of data is that until recently, it has been impossible to accurately measure blood glucose, lactate, and ketone concentrations simultaneously using a small amount of blood. However, we now have the ability to measure glucose, lactate and ketones using 0.1ml of blood. Therefore we have an opportunity to measure and describe the normal concentrations and variations in healthy newborns. FeedingFeeding appears to be the most effective way of preventing hypoglycaemia. Historical reports have shown that prolonged fasting in babies is linked with a progressive fall in blood glucose concentration. ADDIN EN.CITE <EndNote><Cite><Author>Beard</Author><Year>1966</Year><RecNum>415</RecNum><DisplayText><style face="superscript">27</style></DisplayText><record><rec-number>415</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406588159">415</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Beard, A G</author><author>Panos, T C</author><author>Marasigan, B V</author><author>Eminians, J</author><author>Kennedy, H F</author><author>Lamb, J</author></authors></contributors><titles><title>Perinatal stress and the premature neonate. II. Effect of fluid and calorie deprivation on blood glucose</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>329-43</pages><volume>68</volume><number>3</number><edition>1966/03/01</edition><keywords><keyword>Anoxia</keyword><keyword>*Blood Glucose</keyword><keyword>Epinephrine/pharmacology</keyword><keyword>Female</keyword><keyword>Glucagon/pharmacology</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>*Infant, Premature</keyword><keyword>Nutritional Physiological Phenomena</keyword><keyword>Pregnancy</keyword><keyword>Stress, Physiological</keyword></keywords><dates><year>1966</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0022-3476 (Print)
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ADDIN EN.CITE.DATA 28, 29, and others show the opposite. ADDIN EN.CITE <EndNote><Cite><Author>Heck</Author><Year>1987</Year><RecNum>860</RecNum><DisplayText><style face="superscript">12</style></DisplayText><record><rec-number>860</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1415837120">860</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Heck, L J</author><author>Erenberg, A</author></authors></contributors><titles><title>Serum glucose levels in term neonates during the first 48 hours of life</title><secondary-title>J Pediatr Endocrinol Metab</secondary-title><alt-title>The Journal of Pediatrics</alt-title></titles><periodical><full-title>J Pediatr Endocrinol Metab</full-title><abbr-1>Journal of pediatric endocrinology & metabolism : JPEM</abbr-1></periodical><alt-periodical><full-title>The Journal of Pediatrics</full-title></alt-periodical><pages>119-22</pages><volume>110</volume><number>1</number><keywords><keyword>Birth Weight</keyword><keyword>Blood Glucose/*analysis</keyword><keyword>Bottle Feeding</keyword><keyword>Breast Feeding</keyword><keyword>Gestational Age</keyword><keyword>Humans</keyword><keyword>Infant, Newborn/*blood</keyword><keyword>Infant, Small for Gestational Age</keyword><keyword>Reference Values</keyword></keywords><dates><year>1987</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0022-3476 (Print)
0022-3476 (Linking)</isbn><accession-num>3794870</accession-num><urls><related-urls><url> glucose taken post feeds. Combination of both bottle and breast feeds.</research-notes></record></Cite></EndNote>12The original cross-sectional study reported by Hawdon ADDIN EN.CITE <EndNote><Cite><Author>Hawdon</Author><Year>1992</Year><RecNum>143</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>143</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586847">143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hawdon, J M</author><author>Ward-Platt, M P</author><author>Aynsley-Green, A</author></authors></contributors><titles><title>Patterns of metabolic adaption for preterm and term infants in the first neonatal week</title><secondary-title>Arch Dis Child Educ Pract Ed</secondary-title><alt-title>Archives of Disease in Childhood</alt-title></titles><periodical><full-title>Arch Dis Child Educ Pract Ed</full-title><abbr-1>Archives of disease in childhood. Education and practice edition</abbr-1></periodical><alt-periodical><full-title>Archives of Disease in Childhood</full-title><abbr-1>Arch Dis Childhood</abbr-1></alt-periodical><pages>357-365</pages><volume>67</volume><keywords><keyword>metabolic adaption, ketone bodies, lactate, preterm term, reference data</keyword></keywords><dates><year>1992</year></dates><urls></urls></record></Cite></EndNote>16 included healthy term newborns within the first week after birth and showed that breast-fed babies (n =71) had lower blood glucose and higher ketone concentrations over the first four days, when compared with formula feed babies (n= 61). These data have been used to suggest that breast fed babies are protected from the risk of neurological damage because of the increased availability of ketones when compared to formula fed babies. Yet, we have shown in a cohort born 2010 - 2012 that hypoglycaemic newborns have low concentrations of ketones in the first 48 hours.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJyaXM8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 30, 31 Therefore there is an urgent need to determine normal concentrations of lactate and ketones in the context of current feeding recommendations, using a more robust research method. We propose a prospective observational cohort study in healthy term appropriately grown newborns. We will describe the normal blood glucose, lactate and ketone concentrations, using standard blood testing and also continuous interstitial glucose monitoring from soon after birth to the completion of five postnatal days, while also capturing information about feeding.Research PlanStudy designProspective observational cohort studyStudy SettingIt is expected that most babies will be in their own homes for much of the duration of the study. However, babies may start the study at Waikato Women’s Hospital or a primary birthing centre.Study populationInclusion criteriaSingletons37 to 42 completed weeks’ gestation Appropriate weight for gestation age (birthweight ≥ 10th centile and ≤ 90th centile). ADDIN EN.CITE <EndNote><Cite><Author>Fenton</Author><Year>2003</Year><RecNum>937</RecNum><DisplayText><style face="superscript">2</style></DisplayText><record><rec-number>937</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420597689">937</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Fenton, T R</author></authors></contributors><auth-address>Department of Community Health Sciences, Faculty of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta, T2N 4N1, Canada. tanisfenton@shaw.ca</auth-address><titles><title>A new growth chart for preterm babies: Babson and Benda's chart updated with recent data and a new format</title><secondary-title>BMC Pediatrics</secondary-title><alt-title>BMC Pediatr</alt-title></titles><periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></periodical><alt-periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></alt-periodical><pages>13</pages><volume>3</volume><keywords><keyword>*Anthropometry</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Infant, Premature/*growth & development</keyword></keywords><dates><year>2003</year><pub-dates><date>Dec 16</date></pub-dates></dates><isbn>1471-2431 (Electronic)
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ADDIN EN.CITE.DATA 32RecruitmentInformed ConsentAll parents identified before birth as expecting a healthy baby will be provided with an information pamphlet in antenatal areas, midwifery clinics or delivery suite. After discussion with a member of the research team, written informed consent will be sought. A copy of the consent form will be kept with the mother’s midwifery notes and the Lead Maternity Care provider will also receive a letter that will provide details about the study. In addition, consented families will be given information about how to contact a member of the research team prior to the birth of the baby. Babies will be enrolled in the study once eligibility is confirmed immediately after birth.Withdrawal from the StudyParents will be able to discontinue participation in the study at any time. It is expected that some families will withdraw from the study prior the completion of five days. If parents do choose to withdraw, we will seek permission to include all data collected in analysis. If parents do not want their data to be included in the analysis, all data will be returned to the family.Study Procedures (Appendix 1)Daily plan and reviewFollowing the birth of an eligible baby, each family will receive an individual plan, which will outline the time frames in which the research staff will be visiting the baby to perform the blood tests and daily review. A member of the research team will be on call for the parents at all times. In the unlikely event of a baby becoming unwell for any reason, the Lead Maternity Carer will be notified and organise any required referral. Any required investigations, including blood samples, will be taken as clinically indicated, independent of the study protocol, and the baby will remain in the study, unless the parents request otherwise.Blood glucose, lactate and beta-hydroxybutyrate analysisBlood glucose and lactate samples will be analysed using glucose oxidase and lactate oxidase on the portable epoc? analyser (Epocal Inc. Ottawa, Canada). Beta-hydroxybutyrate will be analysed using beta-hydroxybutyrate dehydrogenase on the hand held StatStrip? meter (Nova Biomedical, Waltham, MA, USA).The results screen of both analysers will be covered so that the researcher taking the blood sample will be unaware of the results. Sampling and Timing of the blood samplesDay 1The first blood sample (0.1 ml) will be taken from the umbilical artery immediately after birth. One to two hours following birth, in accordance with the blood glucose screening protocol for at-risk babies at Waikato Hospital, the first heel-prick blood sample will be taken (0.1ml) and will be followed by 3 pre-feed heel-prick samples, at least three to four hours apart. ADDIN EN.CITE <EndNote><Cite><Author>Harris</Author><Year>2012</Year><RecNum>19</RecNum><DisplayText><style face="superscript">10</style></DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1378269043">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Harris, D L</author><author>Weston, P J</author><author>Harding, J E</author></authors></contributors><titles><title>Incidence of neonatal hypoglycemia in babies identified as at risk</title><secondary-title>J Pediatr</secondary-title><alt-title>Journal of Pediatrics </alt-title></titles><periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>787-91</pages><volume>161</volume><number>5</number><edition>23 June 2012</edition><dates><year>2012</year></dates><work-type>Observational</work-type><urls><related-urls><url> Days 2 to 5 Heel-prick blood samples will be measured every 10 to 12 hours. It is standard practice for blood to be collected for the Newborn Screening Card on Day 3 after birth. Every attempt will be made to take one of the study blood samples at the same time. An experienced neonatal nurse will warm the baby’s heel prior to each sample being taken to aid blood flow. In addition, each blood test will be taken just as a feed is being initiated, in order to reduce the pain and discomfort. ADDIN EN.CITE <EndNote><Cite><Author>Carbajal</Author><Year>2003</Year><RecNum>954</RecNum><DisplayText><style face="superscript">33</style></DisplayText><record><rec-number>954</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1420598636">954</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carbajal, R</author><author>Veerapen, S</author><author>Couderc, S</author><author>Jugie, M</author><author>Ville, Y</author></authors></contributors><auth-address>Department of Paediatrics, Poissy-Saint Germain Hospital, 78300 Poissy, France. carbajal@club-internet.fr</auth-address><titles><title>Analgesic effect of breast feeding in term neonates: randomised controlled trial</title><secondary-title>BMJ</secondary-title><alt-title>BMJ</alt-title></titles><periodical><full-title>British Medical Journal</full-title><abbr-1>BMJ</abbr-1></periodical><alt-periodical><full-title>British Medical Journal</full-title><abbr-1>BMJ</abbr-1></alt-periodical><pages>13</pages><volume>326</volume><number>7379</number><keywords><keyword>Analgesia/*methods</keyword><keyword>*Breast Feeding</keyword><keyword>Glucose/administration & dosage</keyword><keyword>Humans</keyword><keyword>*Infant, Newborn</keyword><keyword>Pacifiers</keyword><keyword>Pain/*prevention & control</keyword><keyword>Pain Measurement</keyword><keyword>Phlebotomy/*adverse effects</keyword></keywords><dates><year>2003</year><pub-dates><date>Jan 4</date></pub-dates></dates><isbn>1756-1833 (Electronic)
0959-535X (Linking)</isbn><accession-num>12511452</accession-num><urls><related-urls><url> There will be a maximum of 16 heel-prick blood tests and 1.6 ml of blood sampled over the five days.Continuous interstitial glucose monitorAs soon after birth as possible an Ipro2 continuous glucose monitor (Medtronic, Minimed?, Northridge, USA) will be inserted subcutaneously into the baby’s thigh using the insertion device and remain in place for five days. The sensor will be secured with a transparent dressing. A RemoveTM(Smith & Nephew, Inc., St Petersburg, USA) wipe will be used to remove the dressing and sensor at the end of the study, in order to decrease the potential discomfort of removing the dressing. Following removal of the continuous glucose sensor the skin underneath the sensor will be assessed and cleaned. In the event of the sensor becoming dislodged, we will ask the parents if the sensor can be replaced. If the sensor requires replacement, an addition heel-prick blood test will be required 1 to 2 hours after the insertion of the new sensor.Feeding dataParents will be encouraged to enter details of all feeds (breast or bottle) into a commonly used breastfeeding software application (Feed Baby Pro, Penguin Apps, Version 21.0.5, Victoria, Australia) on a small hand held computer device. At the completion of the five-day study period, data will be exported as a CVS file and stored in a secure database for later analysis. If the parents wish to have a copy of the feeding data in order to continue using the application on a personal device, we will email this information to them.Health information data Maternal dataDemographic details regarding the mothers’ health, previous obstetric history and current pregnancy will be collected from the mothers’ clinical records.Neonatal dataDemographic details about the birth, and weight, length and head circumference will be collected soon after birth and at the end of the study. Follow upBoth parents will be invited independently to complete a short questionnaire about their experience of the study within one week after the completion of the study. The questionnaire will be left for each of the parents at the end of the study. A member of the research team will collect both questionnaires, within the following week.Adverse eventsAll adverse events or concerns will be reported to the Steering Committee Adverse eventRedness or swelling at the insertion site of the continuous glucose monitor.Baby becoming unwell and requiring medical attention.Power and Sample size Approximately 5,800 babies are born within the Waikato region each year. Of these babies 30 % are likely to be at risk of hypoglycaemia and therefore excluded from our possible study population, leaving approximately 4060 babies. The Sugar Babies Study was performed at Waikato Hospital and surrounding Birthing Centres and achieved a 59 % recruitment rate (588/1002). While the population for the GLOW study differs, discussions with both parent groups and Waikato health services about the GLOW study have been supportive of the study. Our first aim is to determine the incidence of neonatal hypoglycaemia within the first 48 hours, using the current definition of < 2.6mM. In the CHYLD Study the incidence of hypoglycaemia in term babies born at risk was 56% (240/258). In the healthy newborn population the incidence of hypoglycaemia is reported to be 15% ADDIN EN.CITE <EndNote><Cite><Author>Hawdon</Author><Year>1992</Year><RecNum>143</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>143</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1406586847">143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hawdon, J M</author><author>Ward-Platt, M P</author><author>Aynsley-Green, A</author></authors></contributors><titles><title>Patterns of metabolic adaption for preterm and term infants in the first neonatal week</title><secondary-title>Arch Dis Child Educ Pract Ed</secondary-title><alt-title>Archives of Disease in Childhood</alt-title></titles><periodical><full-title>Arch Dis Child Educ Pract Ed</full-title><abbr-1>Archives of disease in childhood. Education and practice edition</abbr-1></periodical><alt-periodical><full-title>Archives of Disease in Childhood</full-title><abbr-1>Arch Dis Childhood</abbr-1></alt-periodical><pages>357-365</pages><volume>67</volume><keywords><keyword>metabolic adaption, ketone bodies, lactate, preterm term, reference data</keyword></keywords><dates><year>1992</year></dates><urls></urls></record></Cite></EndNote>16. Using a two-tailed design with alpha at 0.05 and beta at 0.2 we will therefore need 19 babies to demonstrate that the incidence of hypoglycaemia in term healthy babies is significantly lower than in term babies born at risk. However, our major aim is to reliably describe the range and variation of blood glucose concentrations in healthy term babies within the first five postnatal days. The 258 term babies within the CHYLD study had mean glucose concentrations at 12 hours of age of 3.3mM (SD 0.7). In order to have a 95% level of confidence to detect the mean blood glucose concentration to a precision equivalent to a standard error of 0.17mM, we would need to recruit 50 babies. However, we expect some families not to complete the study, so allowing for a 25 % withdrawal rate we will need to recruit 63 babies. Data Analysis Categorical variables will be analysed using number and percent. Continuous variables will be analysed to determine the distribution, range, and variance. Interstitial glucose concentration profiles will be recalibrated PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaWduYWw8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 34, examined for episodes of hypoglycaemia, and quantified for frequency, duration, and severity. ADDIN EN.CITE <EndNote><Cite><Author>Harris</Author><Year>2010</Year><RecNum>21</RecNum><DisplayText><style face="superscript">20</style></DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="wewef20x0xa2z4exet2v55pjvd02f920dwsp" timestamp="1378269044">21</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Harris, D L</author><author>Weston, P J</author><author>Battin, M R</author><author>Harding, J E</author></authors></contributors><titles><title>Continuous glucose monitoring in newborn babies at risk of neonatal hypoglycemia</title><secondary-title>J Pediatr Endocrinol Metab</secondary-title><alt-title>Journal of Pediatrics</alt-title></titles><periodical><full-title>J Pediatr Endocrinol Metab</full-title><abbr-1>Journal of pediatric endocrinology & metabolism : JPEM</abbr-1></periodical><alt-periodical><full-title>Journal of Pediatrics</full-title><abbr-1>J Pediatr</abbr-1></alt-periodical><pages>198-202</pages><volume>157</volume><number>2</number><edition>24 March 2010</edition><dates><year>2010</year></dates><urls><related-urls><url> Feeding data will be time matched with the interstitial glucose profiles and examined for feed-related variation using regression analysis, box plots and area under the curve analyses.Our secondary analysis will include comparing the GLOW glucose and feeding data with data from subgroups of at risk babies (late, preterm, infants of diabetic mothers, small or large for gestation age) previously obtained from the Babies and Sugar Babies studies.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJyaXM8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 20, 21 Data with repeated points, including blood glucose, lactate and ketone concentrations will be compared between babies and within babies, using a mixed model approach. Continuous data will be compared by Student’s t test or the Mann-Whitney U test if the data are not normally distributed and cannot be converted to near-normality by simple transformation. Prior to analysis commencing a statistical analysis plan will be completed.Data security Healthcare professionals involved in the care of pregnant women will identify eligible families. All data collected including NHI number, expected date of delivery, entry criteria meet, and the signed consent form will be held by the principal investigator in a locked office or on a password protected computer. All data collected about families whose babies are not ultimately recruited to the study will be destroyed, although signed consent forms will be retained.Access to health information collected during the study will be limited to recruitment staff. A secure database will hold any identifiable data separately from the trial data and access to this will be limited to the investigators. Only a study number will identify all study data.Research data and all study records will be retained for 10 years after the age of majority.SignificancePresently, there is no reliable description of the normal glucose, lactate and ketone profiles in the first week after birth in healthy, term babies cared for according to contemporary practice. However, babies identified as being at risk for hypoglycaemia soon after birth, most of whom are otherwise healthy, are usually treated for hypoglycaemia if the blood glucose concentration is < 2.6mM. Furthermore, there is no evidence that treating transitional neonatal hypoglycaemia improves the neurological outcome for children or adolescents.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaW48L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA 5, 35 If this study shows that low blood glucose concentrations are common in healthy term babies, it is possible that the current management of neonatal hypoglycaemia will alter considerably, as fewer babies may be screened and treated for hypoglycaemia. This will have significant implications for babies, their families and health care resources. Project ManagementSteering CommitteeDr Deborah Harris (Chair)Dr Phil WestonDistinguished Professor Jane HardingDuties of the Steering CommitteeThe Steering Committee will take overall responsibility for all aspects of the study. Trial DurationRecruitment is expected to commence in October 2015 and is expected to take one year. EthicsThe Northern A Health and Disability Ethics Committee approved the GLOW study on the 19 August 2015 (Number:15/NTA/104)FundingThe Waikato Sick Babies Trust has provided funding for the purchase of the portable epoc? analyser (Epocal Inc. Ottawa. Canada). Waikato Medical Research Foundation have provided funds $30,060.00 which will allow for GLOW to commence. Trial Registration The study will be registered with the Australian and New Zealand Clinical trials Registry (ANZCTR) before recruitment begins.Dissemination of resultsFindings will be presented at local research and community meetings. We will also present findings at both at national and international meetings and publish in international medical journals.References ADDIN EN.REFLIST 1. Villar J, Cheikh Ismail L, Victora CG, Ohuma EO, Bertino E, Altman DG, et al. International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project. Lancet. 2014;384(9946):857-68.2. Fenton TR. A new growth chart for preterm babies: Babson and Benda's chart updated with recent data and a new format. BMC Pediatrics. 2003;3:13.3. Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycaemia. Pediatrics. 2008;122(1):65-74.4. Kerstjens JM, Bocca-Tjeertes IF, de Winter AF, Reijneveld SA, Bos AF. Neonatal morbidities and developmental delay in moderately preterm-born children. Pediatrics. 2012;130(2):265-72.5. Hay WW, Raju T, Higgins R, Kalhan S, Devaskar S. Knowledge gaps and research needs for understanding and treating neonatal hypoglycaemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development. J Pediatr. 2009;155(5):612-7.6. Koh TH, Aynsley-Green A, Tarbit M, Eyre JA. Neural dysfunction during hypoglycaemia. Arch Dis Child. 1988;63:1353-8.7. Lucas A, Morley R, Cole TJ. Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia. BMJ. 1988;297:1304-8.8. Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011;127(3):575-9.9. Canadian Pediatric Society. Screening guidelines for newborns at risk for low blood glucose. Paediatr Child Health. 2004;9(10):723-9.10. Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012;161(5):787-91.11. Srinivasan G, Pildes RS, Cattamanchi G, Voora S, Lilien LD. Plasma glucose values in normal neonates: a new look. J Pediatr. 1986;109(1):114-7.12. Heck LJ, Erenberg A. Serum glucose levels in term neonates during the first 48 hours of life. J Pediatr Endocrinol Metab. 1987;110(1):119-22.13. Cornblath M, Reisner SH. Blood glucose in the neonate and its clinical significance. N Engl J Med. 1965;273(7):378-81.14. Alkalay AL, Sarnat HB, Flores-Sarnat L, Elashoff JD, Farber SJ, Simmons CF. Population meta-analysis of low plasma glucose thresholds in full-term normal newborns. Am J Perinatol. 2006;23(2):115-9.15. American Academy of Pediatrics. Breastfeeding and the Use of Human Milk. Pediatrics. 2012;129(3):e827-41.16. Hawdon JM, Ward-Platt MP, Aynsley-Green A. Patterns of metabolic adaption for preterm and term infants in the first neonatal week. Arch Dis Child Educ Pract Ed. 1992;67:357-65.17. Hoseth E, Joergensen A, Ebbesen F, Moeller M. Blood glucose levels in a population of healthy, breast fed, term infants of appropriate size for gestational age. Arch Dis Child Fetal Neonatal Ed. 2000;83(2):F117-9.18. Diwakar KK, Sasidhar MV. Plasma glucose levels in term infants who are appropriate size for gestation and exclusively breast fed. Arch Dis Child Fetal Neonatal Ed. 2002;87(1):F46-8.19. Hawdon JM, Ward Platt MP, Aynsley-Green A. Patterns of metabolic adaptation for preterm and term infants in the first neonatal week. Arch Dis Child. 1992;67(4 Spec No):357-65.20. Harris DL, Weston PJ, Battin MR, Harding JE. Continuous glucose monitoring in newborn babies at risk of neonatal hypoglycemia. J Pediatr Endocrinol Metab. 2010;157(2):198-202.21. Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. Lancet. 2013;382(9910):2077-83.22. Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer C, van Weissenbruch M, et al. Early insulin therapy in very low birth weight infants. NEMJ. 2008;359(18):1873-84.23. Mola-Schenzle E, Staffler A, Klemme M, Pellegrini F, Molinaro G, Parhofer KG, et al. Clinically stable very low birthweight infants are at risk for recurrent tissue glucose fluctuations even after fully established enteral nutrition. Arch Dis Child Fetal Neonatal Ed. 2014.24. New Zealand College of Midwives. Submission on the Draft Guidelines for the treatment of hypoglycaemia with dextrose gel, within the first 48 hours after birth in late-preterm and term infants. Christchurch, (NZ): 2015.25. Ward Platt M. Lactate, glucose and the neonatal brain: it's time to challenge the paradigm. Arch Dis Child Fetal Neonatal Ed. 2015;100:F 96-7.26. Thornton PS, Stanley CA, De Leon DD, Harris DL, Haymond MW, Hussain K, et al. Recommendations from the Pediatric Endocrine Society for Evaluation and Management of Persistent Hypoglycemia in Neonates, Infants, and Children. J Pediatr. 2015. doi:10.1016/j.jpeds.2015.03.05727. Beard AG, Panos TC, Marasigan BV, Eminians J, Kennedy HF, Lamb J. Perinatal stress and the premature neonate. II. Effect of fluid and calorie deprivation on blood glucose. J Pediatr. 1966;68(3):329-43.28. Wight NE. Hypoglycemia in breastfed neonates. Breastfeeding Medicine. 2006;1(4):253-62.29. Swenne I, Ewald U, Gustafsson J, Sandberg E, Ostenson CG. Inter-relationship between serum concentrations of glucose, glucagon and insulin during the first two days of life in healthy newborns. Acta Paediatrica. 1994;83(9):915-9.30. Harris DL, Weston PJ, Harding JE. Lactate, rather than ketones, may provide alternative cerebral fuel in hypoglycaemic newborns. Arch Dis Child Fetal Neonatal Ed. 2015;100(2):F161-F4.31. Harris DL, Weston PJ, Williams CE, Pleasants AB, Battin MR, Spooner CG, et al. Cot-side electroencephalography monitoring is not clinically useful in the detection of mild neonatal hypoglycemia. J Pediatr. 2011;159(5):755-60.e1.32. Doherty DA, Magann EF, Francis J, Morrison JC, Newnham JP. Pre-pregnancy body mass index and pregnancy outcomes. Int J Gynaecol Obstet. 2006;95(3):242-7.33. Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003;326(7379):13.34. Signal M, Le Compte A, Harris DL, Weston PJ, Harding JE, Chase JG, et al. Impact of retrospective calibration algorithms on hypoglycemia detection in newborn infants using continuous glucose monitoring. Diabetes Technol Ther. 2012;14(10):883-90.35. Tin W, Brunskill G, Kelly T, Fritz S. 15-year follow-up of recurrent "hypoglycemia" in preterm infants. Pediatrics. 2012;130(6):e1497-503.Appendix 1: Procedures for babies participating in GLOW-1262380127571500 ................
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