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)
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...
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| Format: | Article |
| Language: | English |
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BMC
2022-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05994-z |
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| author | Eleanor J. Mitchell Garry Meakin Josie Anderson Jon Dorling Chris Gale Rachel Haines Charlotte Kenyan Mark J. Johnson William McGuire Hema Mistry Alan Montgomery Sam Oddie Reuben Ogollah Phoebe Pallotti Christopher Partlett Kate F. Walker Shalini Ojha |
| author_facet | Eleanor J. Mitchell Garry Meakin Josie Anderson Jon Dorling Chris Gale Rachel Haines Charlotte Kenyan Mark J. Johnson William McGuire Hema Mistry Alan Montgomery Sam Oddie Reuben Ogollah Phoebe Pallotti Christopher Partlett Kate F. Walker Shalini Ojha |
| author_sort | Eleanor J. Mitchell |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T13:49:50Z |
| format | Article |
| id | doaj.art-236d43d743eb4904826dfc81301df5f8 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T13:49:50Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-236d43d743eb4904826dfc81301df5f82022-12-21T23:43:16ZengBMCTrials1745-62152022-01-0123111210.1186/s13063-021-05994-zThe 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)Eleanor J. Mitchell0Garry Meakin1Josie Anderson2Jon Dorling3Chris Gale4Rachel Haines5Charlotte Kenyan6Mark J. Johnson7William McGuire8Hema Mistry9Alan Montgomery10Sam Oddie11Reuben Ogollah12Phoebe Pallotti13Christopher Partlett14Kate F. Walker15Shalini Ojha16Nottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamNottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamBliss, 4th Floor Maya HouseDepartment of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust and NIHR Biomedical research Centre Southampton, University Hospital Southampton NHS Foundation Trust and University of SouthamptonNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital campusNottingham Clinical Trials Unit, Building 42, University Park, University of Nottinghamc/o Nottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamDepartment of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust and NIHR Biomedical research Centre Southampton, University Hospital Southampton NHS Foundation Trust and University of SouthamptonCentre for Reviews and Dissemination, University of YorkWarwick Clinical Trials Unit, Warwick Medical School, University of WarwickNottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamDepartment of Neonatal Medicine, Bradford Teaching Hospitals NHS Foundation TrustNottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamDivision of Midwifery, School of Health Sciences, University Park, University of NottinghamNottingham Clinical Trials Unit, Building 42, University Park, University of NottinghamPopulation and Applied Health Sciences, School of Medicine University of Nottingham, University ParkPopulation and Applied Health Sciences, School of Medicine University of Nottingham, University ParkAbstract 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.https://doi.org/10.1186/s13063-021-05994-zClinical trialProtocolPreterm infantFeedingNeonatalFull milk |
| spellingShingle | Eleanor J. Mitchell Garry Meakin Josie Anderson Jon Dorling Chris Gale Rachel Haines Charlotte Kenyan Mark J. Johnson William McGuire Hema Mistry Alan Montgomery Sam Oddie Reuben Ogollah Phoebe Pallotti Christopher Partlett Kate F. Walker Shalini Ojha 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 Clinical trial Protocol Preterm infant Feeding Neonatal Full milk |
| 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Clinical trial Protocol Preterm infant Feeding Neonatal Full milk |
| url | https://doi.org/10.1186/s13063-021-05994-z |
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