Harding 2020.

Study characteristics
Methods	Randomised parallel controlled trial
Participants	2149 infants (16 infants randomised in error) Inclusion criteria: infants of diabetic mothers or late preterm infants (35 to 36 weeks' gestation) or small (< 2.5 kg or < 10th percentile) or large (> 4.5 kg or > 90th percentile) infants Exclusion criteria: major congenital abnormality; previous formula feed or intravenous fluids; previous diagnosis of hypoglycaemia; admitted to NICU; imminent admission to NICU Setting: multi‐centre Timing: January 2015 to May 2019
Interventions	40% dextrose gel massaged into buccal mucosa as a single dose (0.5 mL/kg) 1 hour after birth (n = 1070) vs Placebo gel massaged into buccal mucosa using same protocol as the intervention (n = 1063)
Outcomes	Primary outcome Admission to NICU (defined as admission to NICU (or special care baby unit (SCBU) for hospitals using that name) for > 4 hours) ‐ no difference between oral dextrose and placebo groups Secondary outcomes • Hypoglycaemia (any blood glucose concentration < 2.6 mmol/L in first 48 hours) ‐ lower incidence in oral dextrose gel group • Admission to NICU for hypoglycaemia ‐ no difference between oral dextrose and placebo groups • Hyperglycaemia (any blood glucose concentration > 10 mmol/L) ‐ no cases • Breastfeeding at discharge from hospital (full or exclusive) ‐ no difference between oral dextrose and placebo groups • Receipt of any formula before discharge from hospital ‐ no difference between oral dextrose and placebo groups • Formula feeding at 6 weeks of age ‐ no difference between oral dextrose and placebo groups • Cost of care until primary discharge home ‐ reported separately • Maternal satisfaction (via telephone questionnaire at 6 weeks) ‐ high • Neurosensory disability at 2 years’ corrected age (any of the following: legal blindness; sensorineural deafness requiring hearing aids; cerebral palsy; Bayley Scale of Infant Development Version III cognitive, language or motor score < 1 standard deviation below the mean) ‐ follow‐up in progress
Notes	Trials registration: ACTRN12614001263684
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Babies will be assigned randomly via an internet randomisation service to the dextrose or placebo group with priority stratification for collaborating centre and risk factor"
Allocation concealment (selection bias)	Low risk	Quote: "Staff at the study site accessed a centralised internet based randomisations service within the first hour after birth to receive a study number which corresponded to a study treatment pack containing a single pre‐packaged syringe of 40% dextrose gel or identical appearing 2% hydroxymethylcellulose placebo gel (1:1 ratio)"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote. "Families, study and site staff and investigators were all blinded to treatment allocation"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "...study and site staff and investigators were all blinded to treatment allocation"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "All analyses were pre‐specified and carried out using a modified intention‐to‐treat approach in which babies randomised in error (did not meet eligibility criteria at randomisation) were excluded, but all other babies were analysed in the groups which they were allocated".
Selective reporting (reporting bias)	Low risk	Yes all outcomes mentioned in the protocol were published
Other bias	Low risk	Groups were well balanced for maternal and demographic variables. We conclude that the study is not at risk of other bias.