A randomised controlled trial of full milk feeds versus intravenous nutrition with gradual feeding for preterm infants (30-33 weeks gestational age)

niversity Hospitals of Derby and Burton NHS Foundation Trust0 sites2,088 target enrollmentSeptember 23, 2019

Overview

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35057837/ (added 24/01/2022)

Registry

who.int

Start Date

September 23, 2019

End Date

September 30, 2027

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals of Derby and Burton NHS Foundation Trust

•1\. Infant born at 30 weeks \+ 0 days to 32 weeks \+ 6 days gestation, inclusive
•2\. Infant \<3 hours (180 minutes) old (since recorded time of birth)
•(Infants requiring respiratory support (such as via continuous positive airway pressure) or other supportive treatments will be included in the study if the attending clinician is in equipoise about the infant being randomised to either the full milk” or the gradual milk” arm. Similarly, well infants should only be included if the attending clinician is in equipoise about the best feeding regime and the infant being randomised to either full milk” or gradual milk” groups.)

•1\. Infant with known congenital abnormalities of the gastrointestinal tract or other congenital conditions that make enteral feeding unsafe
•2\. Infant who are small for gestational age (birth weight \<10th centile) AND evidence of reversed end\-diastolic flow on antenatal umbilical artery Doppler ultrasound\*
•3\. Mother has participated in the trial during a previous pregnancy\#
•\*Small for gestational age infants with antenatal Doppler ultrasound scan showing absent umbilical artery flow or whose mother’s did not have antenatal umbilical Doppler ultrasound may be eligible for the trial if they meet the other inclusion criteria.
•\#The trial will recruit over 36 months. It is possible that the mother of an infant(s) who has already participated in the trial has another pregnancy in this duration. In such circumstances, the infant(s) born in subsequent pregnancies will be excluded to avoid bias due to the experience of previous participation.