CTRI/2017/11/010645.

Methods	Randomised parallel controlled trial
Participants	611 infants Inclusion criteria: infants of diabetic mothers, > 35 weeks’ gestation and birthweight > 2 kg Exclusion criteria: major congenital malformation or requiring admission to NICU before randomisation for any of the following: < 35 weeks’ gestation, birthweight < 2 kg, respiratory distress, major lethal congenital malformation, antenatal ultrasound findings with absent/reversal of diastolic mesenteric flow, Rh negative mother with DCT positive baby and indication suggested by consultants Setting: India
Interventions	40% dextrose gel (0.5 ml/L) massaged into the buccal mucosa after birth followed by a breast feed within 30 minutes after birth vs Breast feed within 30 minutes after birth
Outcomes	Primary outcome Incidence of hypoglycaemia until 24 hours after birth Secondary outcomes Reduction in admission rate due to hypoglycaemia until 24 hours after birth Formulation of scoring system to predict the responder and non‐responder to oral dextrose gel based on prespecified risk factors at 1.5 hours after birth Rate of exclusive breastfeeding until discharge Rate of exclusive breastfeeding up to 6 months of age Maternal satisfaction at discharge Incidence of sepsis without antenatal risk of sepsis until discharge Reduction in admission rate due to hypoglycaemia until 24 hours after birth Maximum requirement of glucose infusion rate until 24 hours after birth Incidence of rebound hypoglycaemia until 24 hours after birth Incidence of hyperglycaemia until 24 hours after birth Incidence of late hyperglycaemia until 24 hours after birth Incidence of feeding intolerance until 24 hours after birth Incidence of necrotising enterocolitis until 24 hours after birth Number needed to treat until 24 hours after birth Compliance of care until 24 hours after birth Onset of action and duration of action of oral dextrose gel until 24 hours after birth Rate of rise of glucose due to oral dextrose gel until 24 hours after birth Duration of hospital stay within 28 days after birth
Notes	Trial registration: CTRI/2017/11/010645. Trial completed but unpublished ‐ authors contacted in May 2023 for additional information.