TCTR20190805003.
Methods | Randomised double‐blind, placebo‐controlled trial |
Participants | 600 infants Inclusion criteria: late preterm (34 to 37 weeks' gestation), small (< 10th centile) or large‐for‐gestational age (> 90th centile), infants of diabetic mothers, low birthweight (< 2500 g) or macrosomia ( > 4000 g). Exclusion criteria: received oral feed or intravenous treatment for hypoglycaemia, congenital abnormality, admission to NICU, birthweight < 1800 grams. Setting: Thailand |
Interventions | 40% dextrose gel (0.5 ml/L) applied into the buccal mucosa within 48 hours after birth vs arboxymethyl cellulose placebo gel massaged into the buccal mucosa using the same protocol as the intervention |
Outcomes |
Primary outcome
Secondary outcomes
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Notes | Trial registration: TCTR20190805003. Trial completed but unpublished ‐ authors contacted in October 2020 for additional information |
BMI: body mass index; DCT: Direct Coombs Test; NICU: neonatal intensive care unit; Rh: rhesus; vs: versus.