BibTex format
@article{Mitchell:2022:10.1186/s13063-021-05994-z,
author = {Mitchell, EJ and Meakin, G and Anderson, J and Dorling, J and Gale, C and Haines, R and Kenyan, C and Johnson, MJ and McGuire, W and Mistry, H and Montgomery, A and Oddie, S and Ogollah, R and Pallotti, P and Partlett, C and Walker, KF and Ojha, S},
doi = {10.1186/s13063-021-05994-z},
journal = {Trials},
pages = {1--12},
title = {The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age)},
url = {http://dx.doi.org/10.1186/s13063-021-05994-z},
volume = {23},
year = {2022}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - BackgroundIn the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units’ workload. Neonatologists are cautious in initiating full milk feeds for preterm infants due to fears of necrotising enterocolitis (NEC). There is now evidence to dispute this fear. Small studies have shown that feeding preterm infants full milk feeds enterally from birth could result in a shorter length of hospital stay, which is important to parents, clinicians and NHS services without increasing the risk of NEC. This trial aims to investigate whether full milk feeds initiated in the first 24 h after birth reduces the length of hospital stay in comparison to introduction of gradual milk feeding with IV fluids or parenteral nutrition.MethodsFEED1 is a multi-centre, open, parallel group, randomised, controlled superiority trial of full milk feeds initiated on the day of birth versus gradual milk feeds for infants born at 30+0 to 32+6 (inclusive) weeks gestation. Recruitment will take place in around 40 UK neonatal units. Mothers will be randomised 1:1 to full milk feeds, starting at 60 ml/kg day, or gradual feeds, as per usual local practice. Mother’s expressed breast milk will always be the first choice of milk, though will likely be supplemented with formula or donor breast milk in the first few days. Feeding data will be collected until full milk feeds are achieved (≥ 140 ml/kg/day for 3 consecutive days). The primary outcome is length of infant hospital stay. Additional data will be collected 6 weeks post-discharge. Follow-up at 2 years (corrected gestational age) is planned. The sample size is 2088 infants to detect a between group difference in length of stay of 2 days. Accounting for multiple births, this requires 1700 women to be recruited. Primary analysis will compare the length of
AU - Mitchell,EJ
AU - Meakin,G
AU - Anderson,J
AU - Dorling,J
AU - Gale,C
AU - Haines,R
AU - Kenyan,C
AU - Johnson,MJ
AU - McGuire,W
AU - Mistry,H
AU - Montgomery,A
AU - Oddie,S
AU - Ogollah,R
AU - Pallotti,P
AU - Partlett,C
AU - Walker,KF
AU - Ojha,S
DO - 10.1186/s13063-021-05994-z
EP - 12
PY - 2022///
SN - 1745-6215
SP - 1
TI - The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age)
T2 - Trials
UR - http://dx.doi.org/10.1186/s13063-021-05994-z
UR - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05994-z
UR - http://hdl.handle.net/10044/1/93867
VL - 23
ER -
