Speed of Increasing milk Feeds Trial

Phase 3

Completed

• Conditions: eonatal feeding, preterm infants, very low birth weight infants, necrotising enterocolitis, late-onset invasive infection; Pregnancy and Childbirth; Other preterm infants

• Registration Number: ISRCTN76463425
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28129748 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31597020 results (added 10/10/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32342857 results (added 29/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34419121/ Study Within A Trial (SWAT) (added 23/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Study Completion: 2018-05-10
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2804

Inclusion Criteria

1. Gestational age at birth <32 weeks, or birth weight <1,500 g
2. The infant is receiving =30 ml/kg/day of milk at randomisation
3. Written informed parental consent is obtained
To ensure the widest applicability to preterm infants across the UK, those exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included.

Exclusion Criteria

1. Infants with a severe congenital anomaly
2. Infants who, in the opinion of the treating clinician, have no realistic chance of survival
3. Infants who are unlikely to be traceable for follow-up at 24 months of age (for example, infants of non-UK residents)

Study & Design

• Study Type: Interventional
• Study Design: Not specified