A multi-centre randomised controlled trial of two speeds of daily increment of milk feeding in very preterm or very low birth weight infants

niversity of Oxford (UK)0 sites2,804 target enrollmentMarch 14, 2013

Overview

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)

Registry

who.int

Start Date

March 14, 2013

End Date

May 10, 2018

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Oxford (UK)

•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.

•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)