NCT04353713.

Study name	Gel for early hypoglycaemia prevention in preterm infants
Methods	Multi‐centre, randomised double‐blind, placebo‐controlled trial
Participants	534 infants Inclusion criteria: Infants ≤ 32 weeks’ gestation Exclusion criteria: planned comfort care (palliative approach) after delivery Setting: Ireland
Interventions	40% oral dextrose gel (0.5 ml/L) massaged into the buccal mucosa immediately after stabilisation or resuscitation at birth prior to in‐house transport from the delivery ward to the NICU vs 2% hydroxymethylcellulose placebo gel massaged into the buccal mucosa using the same protocol and volume as the intervention
Outcomes	Primary outcome Proportion of infants with initial hypoglycaemia defined as a glucose concentration < 1.8 mmol/L at 30 to 60 minutes after birth Secondary outcomes Proportion of infants with any hypoglycaemia episode within 24 hours after birth Proportion of infants with a hypoglycaemia episode within 24 hours after birth Number of episodes of hypoglycaemia within 24 hours after birth Proportion of infants with a hyperglycaemia episode within 24 hours after birth Proportion of infants who received rescue intravenous dextrose within 24 hours after birth Tolerance of buccal gel in delivery room Incidence of symptomatic hypoglycaemia within 24 hours after birth Proportion of infants who died within 12 hours after birth Proportion of infants who died > 12 hours after birth but prior to discharge home Incidence of early bacterial sepsis and/or meningitis within 3 days after birth Incidence of necrotising enterocolitis within 6 months after birth Proportion of infants with severe retinopathy of prematurity requiring treatment within 6 months after birth Proportion of infants with severe (grade III/IV) intraventricular‐germinal matrix haemorrhage within 6 months after birth Proportion of infants with periventricular leukomalacia within 6 months after birth
Starting date	1 July 2020
Contact information	jkelleher@coombe.ie
Notes	Trial registration: NCT04353713

NICU: neonatal intensive care unit
vs: versus