NCT04185766.

Methods	Randomised parallel controlled trial
Participants	172 infants  Inclusion criteria: late preterm and term infants (34 to 42 weeks’ gestation), small (< 10th centile) or large‐for‐gestational age (> 90thcentile), natural birth, rooming‐in and body temperature between 36.5 to 37.5 degrees. Mother intends to breastfeed and has a BMI between 19 and 24. Exclusion criteria: major congenital malformations, blood glucose concentration < 47 mg/dL (2.6 mmol/L), NICU admission, milk intake in formula, intravenous infusion of 10% glucose solution, metabolic and respiratory acidosis (pH: 7.28 to 7.38) or mother taking medications during pregnancy.  Setting: Poliambulanza Foundation Hospital Institute, Brescia, Italy.
Interventions	40% Destrogel as a single dose (0.5 mL/kg or 1 mL/kg) massaged into the buccal mucosa at one hour after birth (n = 86) vs Placebo gel massaged into the buccal mucosa using the same protocol and volume as the intervention (n = 86)
Outcomes	Primary outcome  The incidence of hypoglycaemia until 48 hours after birth  Secondary outcomes Incidence of the use of formula milk until 48 hours after birth Incidence of the administration of 10% intravenous glucose solution until 48 hours after birth Reducing artificial breastfeeding until 48 hours after birth Reducing the pain of the infant during the execution of peripheral venous access for the administration of hypoglycaemia therapy until 48 hours after birth
Notes	Trial registration: NCT04185766. Trial completed but unpublished ‐ authors contacted in August 2020 for additional information