The Speed of Increasing milk Feeds: a randomised controlled trial

BMC Pediatrics

Study Protocol

Jane Abbott¹  William McGuire²  Alison Leaf³  Edmund Juszczak⁴  Ursula Bowler⁴  Louise Linsell⁴  Elaine Boyle⁵  Samantha Johnson⁵  Jon Dorling⁶  Tracy Roberts⁷  Kenny McCormick⁸  Janet Berrington⁹  Nicholas Embleton⁹  Ben Stenson^1,10 

[1] BLISS, London, UK;Centre for Reviews and Dissemination, University of York, York, UK;Child Health, Southampton, UK;Clinical Trials Unit, National Perinatal Epidemiology Unit, Oxford University, Oxford, UK;Department of Health Sciences, University of Leicester, Leicester, UK;Division of Child Health, Obstetrics and Gynaecology, School of Medicine, University of Nottingham, Nottingham, UK;Health and Population Sciences, University of Birmingham, Birmingham, UK;John Radcliffe Hospital, Oxford, UK;Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne, UK;Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK;

关键词: Preterm infants;    Milk feeds;    Milk volume;    Prematurity;    NEC;    Sepsis;    Parenteral nutrition;    Neurodevelopment;    RCT;   

DOI  :  10.1186/s12887-017-0794-z

 received in 2016-11-01, accepted in 2017-01-18,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIn the UK, 1–2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth.Methods/designTwo thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire.DiscussionExtensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal feeding strategy, and therefore if successful, the trial results could rapidly be adopted across the NHS at low cost.Trial registrationISRCTN Registry; ISRCTN76463425 on 5 March, 2013.

【 授权许可】

CC BY   
© The Author(s). 2017