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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)

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Mitchell, Eleanor J., Meakin, Garry, Anderson, Josie, Dorling, Jon, Gale, Chris, Haines, Rachel, Kenyan, Charlotte, Johnson, Mark J., McGuire, William, Mistry, Hema, Montgomery, Alan, Oddie, Sam, Ogollah, Reuben, Pallotti, Phoebe, Partlett, Christopher, Walker, Kate F. and Ojha, Shalini (2022) 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). Trials, 23 (1). 64. doi:10.1186/s13063-021-05994-z

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Official URL: https://doi.org/10.1186/s13063-021-05994-z

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Abstract

Background: In 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. Methods: FEED1 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 hospital stay between groups, adjusting for minimisation variables and accounting for multiple births. Discussion: This trial will provide high-quality evidence on feeding practices for preterm infants. Full milk feeds from day of birth could result in infants being discharged sooner. Trial registration: ISRCTN ISRCTN89654042. Prospectively registered on 23 September 2019: ISRCTN is a primary registry of the WHO ICTRP network, and all items from the WHO Trial Registration dataset are included.

Item Type: Journal Article
Subjects: R Medicine > RJ Pediatrics
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
SWORD Depositor: Library Publications Router
Library of Congress Subject Headings (LCSH): Premature infants -- Nutrition, Enteral feeding, Premature infants -- Care
Journal or Publication Title: Trials
Publisher: BioMed Central
ISSN: 1745-6215
Official Date: 20 January 2022
Dates:
DateEvent
20 January 2022Published
30 December 2021Accepted
Volume: 23
Number: 1
Article Number: 64
DOI: 10.1186/s13063-021-05994-z
Status: Peer Reviewed
Publication Status: Published
Reuse Statement (publisher, data, author rights): ** From Springer Nature via Jisc Publications Router ** History: received 12-04-2021; accepted 30-12-2021; registration 31-12-2021; pub-electronic 20-01-2022; online 20-01-2022; collection 12-2022. ** Licence for this article: http://creativecommons.org/licenses/by/4.0/
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
17/94/31[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
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