Newborn infants with risk factors for hypoglycaemia Pregnancy and Childbirth
Conditions
Interventions
The SWIFT (Supplementation with or without formula trial) study is a pilot and feasibility trial, designed to compare the intended or actual use of donor human milk (DHM) where there is a medically in
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Breastfeeding rates and adverse outcomes measured daily using electronic medical records 1. Episodes of hypoglycaemia (Glucose <2.6mmol/L) 2. Adverse outcomes, for example, admission to the neonatal unit 3. Breastfeeding duration (any and exclusive) at discharge and by telephone call at 6 weeks, 3 months post-discharge 4. Use of nasogastric tube feeding or other supplemental feeding methods 5. Length of hospital stay 6. Stools day 0, day 3, 6 weeks corrected age (sent via post) by collection from nappy analysed for: 6.1. Microbiome (16s) 6.2. Calprotectin Trial feasibility outcomes measured monthly using electronic medical and study records: 1. Recruitment rates/eligible infants per month 2. Numbers of infants: 2.1. Recruited before or after delivery 2.2. Recruited during normal working hours 2.3. Receiving non-MOM milk or hypoglycaemic before trial enrolment 3. Numbers of mothers: 3.1. Declining enrolment 3.2. Not returning completed questionnaires 3.3. Unable to contact by telephone post-discharge (lost to follow-up) | — |
Countries
England, United Kingdom
Contacts
Public ContactNicholas Embleton
Outcome results
None listed