hPOD - Hypoglycaemia Prevention in newborns with Oral Dextrose

Phase 3

Active, not recruiting

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

• Registration Number: ACTRN12614001263684
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2149

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/SCB

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Admission to NICU, defined as admission to Neonatal Intensive Care Unit (NICU), or Special Care Baby Unit (SCBU) for the hospitals which use that name, for > 4 hours, determined from medical records. [ Prior to discharge home.]