Hypoglycaemia Prevention in Newborns with Oral Dextrose: the dosage trial

INTERVENTION: This trial is a dosage trial to determine the most effective dose and frequency of 40% dextrose gel in preventing hypoglycaemia. There will be 8 arms, 4 intervention and 4 placebo. All doses will be administered by massage into the buccal mucosa immediately prior to a breastfeed, beginning with the first feed no later than one hour after birth. Intervention arms ‐ 40% dextrose: Arm 1 Single dose arm; 200mg/kg (0.5ml/kg) before first feed Arm 2 Multiple dose arm; 200mg/kg (0.5ml/kg) given pre‐feed, before the first four feeds Arm 3 Single, higher dose arm; 400mg/kg (1ml/kg) before first feed Arm 4 Multiple, higher dose arm; 400mg/kg (1ml/kg) before first feed, followed by 200mg/kg (0.5ml/kg), given pre‐feed, before the next three feeds The most effective dose will subsequently be used in a multicentre trial with a primary outcome of reduction in admission to NICU. The multicentre trial will be registered with ANZCTR separately. CONDITION: Neonatal Hypoglycaemia PRIMARY OUTCOME: Incidence of neonatal hypoglycaemia (any blood glucose concentration <2.6mM measured by the glucose oxidase method). SECONDARY OUTCOME: Admission to NICU or SCBU for > 4 hours duration, where the primary reason for admission is hypoglycaemia. Admission to NICU, defined as admission to Neonatal Intensive Care Unit (NICU), or Special Care Baby Unit (SCBU) for the hospitals which use that name, for > 4 hours, determined from medical records. Breastfeeding (full or exclusive), determined by parental questionnaire. Economic cost of healthcare to discharge, determined using resource utilisation data from clinical records. Formula feeding at day 3 and 6 weeks after birth, determined by parental questionnaire. Hyperglycaemia (any blood glucose concentration of > 10mmol/l measured by the glucose oxidase method). Maternal satisfaction, determined by parental questionnaire. Received any formula before day 3 and 6 weeks after birth, determined by parental questionnaire. INCLUSION CRITERIA: Babies who are at risk of hypoglycaemia, defined as satisfying AT LEAST ONE of the following: 1. Infants of diabetic mothers (any type of diabetes) 2. Preterm (< 37 weeks' gestation) 3. Small (< 2.5kg or < 10th centile on population or customised birthweight chart) 4. Large (> 4.5kg or > 90th centile on population or customised birthweight chart) 5. Other risk e.g. maternal medication AND satisfy ALL of the following: 1. > or = 35+0 weeks' gestation 2. Birthweight > 2.2kg 3. < 1 hour old 4. No apparent indication for NICU/SCBU admission at time of randomisation 5. Unlikely to require admission to NICU/SCBU for any other reason e.g. respiratory distress 6. Mother intending to breastfeed.