Hypoglycaemia Prevention in Newborns with Oral Dextrose: the dosage trial

Phase 3

Active, not recruiting

• Conditions: eonatal Hypoglycaemia; Neonatal Hypoglycaemia; Metabolic and Endocrine - Other metabolic disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12613000322730
• Lead Sponsor: niversity of Auckland

Brief Summary

Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo. A single dose of 200mg/kg dextrose gel was most effective and best tolerated. Rates of NICU admission were similar, but admission for hypoglycaemia was less common in babies randomised to dextrose gel. Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. At two years of age there was no difference between any of the groups in the risk of neurosensory impairment or low executive function, or in any of the secondary outcomes. Prophylactic dextrose gel appears safe to two years' corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-22
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 416

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)
5. Other risk e.g. maternal medication

AND satisfy ALL of the following:
1. > or = 35+0 weeks' gestation
2. Birthweight > 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/SCB

Study & Design

• Study Type: Interventional
• Study Design: Not specified