hPOD - Hypoglycaemia Prevention in newborns with Oral Dextrose

Conditions

None listed

Brief summary

Hypoglycaemia is the commonest metabolic condition of the newborn. It affects up to 15% of babies, and the incidence is increasing as risk factors such as maternal diabetes and preterm birth are becoming more common. Neonatal hypoglycaemia frequently leads to neonatal intensive care unit (NICU) admission and may cause long-term brain damage. There currently are no evidence-based strategies to prevent hypoglycaemia and its adverse consequences. The purpose of this trial is to determine whether prophylactic dextrose gel prevents admission to NICU.

Jane E. Harding, Jane M. Alsweiler, Gavin Brown, Gregory D. Gamble, Alicia McNeill et al. (26 authors)

JAMA Pediatrics2026-06-29

10.1001/jamapediatrics.2026.2486

Prophylactic Oral Dextrose Gel and Neurosensory Impairment at 2-Year Follow-up of Participants in the hPOD Randomized Trial

Taygen Edwards, Jane M. Alsweiler, Caroline A Crowther, Richard Edlin, Greg Gamble et al. (12 authors)

JAMA2022-03-2230 citations

10.1001/jama.2022.2363

Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study)

Joanne E Hegarty, Jane E. Harding, Gregory D. Gamble, Caroline A Crowther, Richard Edlin et al. (6 authors)

PLoS Medicine2016-10-2598 citations

10.1371/journal.pmed.1002155

Interventions

40% dextrose gel. Dose of 200mg/kg (0.5ml/kg), given at 1 hour of age, followed by breastfeed. Administered by massage into the buccal mucosa. The dose of 40% dextrose gel in this trial has been informed by the pre-hPOD dosage trial (ACTRN12613000322730).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to 1 Hours

Healthy volunteers

No

Inclusion criteria

Babies who are at risk of hypoglycaemia, defined as satisfying AT LEAST ONE of the following: 1. Infants of diabetic mothers (any type of diabetes) 2. Preterm (< 37 weeks' gestation) 3. Small (< 2.5kg or < 10th centile on population or customised birthweight chart) 4. Large (> 4.5kg or > 90th centile on population or customised birthweight chart) AND satisfy ALL of the following: 1. > or = 35+0 weeks' gestation 2. Birthweight > or = 2.2kg 3. < 1 hour old 4. No apparent indication for NICU/SCBU admission at time of randomisation 5. Unlikely to require admission to NICU/SCBU for any other reason e.g. respiratory distress 6. Mother intending to breastfeed

Exclusion criteria

1. Major congenital abnormality 2. Previous formula feed or intravenous fluids 3. Previous diagnosis of hypoglycaemia 4. Admitted to NICU/SCBU 5. Imminent admission to NICU/SCBU

Outcome results