Support with or without formula trial for infants at risk of hypoglycaemia
Not Applicable
- Conditions
- ewborn infants with risk factors for hypoglycaemiaPregnancy and Childbirth
- Registration Number
- ISRCTN16997288
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Newborn infants <24 hours of age who do not require admission for neonatal intensive care or intravenous therapy but who are at risk factors for hypoglycaemia:
1. Born at 32-36 weeks gestation
2. In-utero growth restriction (defined by unit guidelines)
3. Birthweight <2.5kg
4. Maternal use of B-blockers
5. Maternal diabetes
6. Other conditions where in the opinion of the medical and nursing team the infant requires additional milk to protect the infant’s health
Exclusion Criteria
1. Parents unwilling to accept donated human milk
2. Mother’s not wishing to breastfeed
3. Infant requiring intravenous fluids at birth
4. Inability to randomise within 24 hours of birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breastfeeding rate measured using electronic medical records at hospital discharge. This outcome is also met if a mother is actively expressing breastmilk which the infant receives wholly or in part via a bottle.
- Secondary Outcome Measures
Name Time Method