Supplementary donor breast milk versus formula as a bridge to exclusive breast milk feeds at discharge in moderate and late preterm infants

A randomised controlled trial to investigate whether in moderate and late preterm infants (33-35 weeks gestation) using supplementary donor breast milk versus formula for the first 5 days as a bridge to breast milk feeding improves exclusive breast milk feeds on discharge.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81620277

Enrollment

334

Registered

2025-11-03

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encourage breast milk feeds in moderate to late preterm infants (33 to 35 week gestation). Pregnancy and Childbirth

Interventions

This is a randomised, controlled, superiority trial. The intervention product is donor breast milk. The control will be formula milk. All infants born at 33 weeks to 35 weeks gestation at Southmead an

Eligibility

Sex/Gender

All

Age

0 Days to 5 Days

Inclusion criteria

Inclusion criteria: 1. Infants born 33 weeks +0 days to 35 weeks +6 days gestation. 2. Randomised prior to introduction of supplementary enteral feeds. 3. Infants requiring respiratory support or other medical support can be included at the discretion of the clinician caring for the infant 4. Singleton or multiple births 5. Mother intends to breast feed 6. The mother must consent for use of Donor Breast Milk (DBM)

Exclusion criteria

Exclusion criteria: 1. Known congenital abnormalities of gastrointestinal tract 2. Abnormalities that make enteral feeding unsafe e.g. metabolic condition 3. Those who qualify for DBM under present guidelines (birth weight <1500g, reverse diastolic flow on antenatal doppler) 4. Mother has no intention to breast feed 5. Mother declines use of Donor Breast Milk 6. Received any formula feed prior to randomisation 7. Consenting mother is under the age of 16 8. Unlikely to remain at recruiting NICU for duration of intervention (5 days)

Design outcomes

Primary

Measure	Time frame
Exclusive breast milk feeding on discharge from neonatal care measured using patient records	—

Secondary

Measure	Time frame
Measured using patient records: 1. The amount of donor breast milk and formula required to supplement mother's own milk in the first 5 days. 2. Exclusive breast feeding at discharge, 6 weeks, 3 months and 6 months corrected age 3. Feed tolerance (the time taken to reach full feeds) 4. Invasive interventions (intravenous access) during hospital stay 5. Health outcomes related to prematurity at discharge 6. Length of stay	—

Measure

Time frame

Measured using patient records: 1. The amount of donor breast milk and formula required to supplement mother's own milk in the first 5 days. 2. Exclusive breast feeding at discharge, 6 weeks, 3 months and 6 months corrected age 3. Feed tolerance (the time taken to reach full feeds) 4. Invasive interventions (intravenous access) during hospital stay 5. Health outcomes related to prematurity at discharge 6. Length of stay

—

Countries

England, United Kingdom

Contacts

Public ContactRichard Wach

richard.wach@nbt.nhs.uk+44 117 414 6800

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026