Speed of Increasing Milk Feeds Trial (SIFT)
A Multi-centre Randomised Controlled Trial of Two Speeds of Daily Increment of Milk Feeding in Very Preterm or Very Low Birth Weight Infants
Survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these babies and to avoid serious complications. The way babies are fed in early life affects short and long-term health and survival.
Because the bowels of preterm infants have not matured, they cannot digest large volumes of milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip while the amount of milk given is gradually increased over time. Increasing the amount of milk rapidly may increase the risk of gut complications. Increasing the amount of milk given more slowly means that intravenous nutrition is needed for longer; there is an associated risk of infection proportional to the time the intravenous line is present in the bloodstream of these infants. Despite the importance of milk feeding preterm infants, there have been few studies to inform how best to balance these risks, and what the best way to increase feeds in these infants is - this study sets out to address this missing information.
The study will compare two different speeds of milk feed increase, one 'faster' and one 'slower', both within rates currently used in United Kingdom neonatal units. The study aims to find out if either speed of milk feed increase gives better outcomes for the infants. Investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the National Health Service, including costs.
The study is being led by an established team of researchers who have run similar studies before, and uses an established network of neonatal units that have taken part in previous studies.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dublin、爱尔兰、Dublin 2
- National Maternity Hospital, Dublin
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Ashford、英国、TN24 0LZ
- William Harvey Hospital
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Belfast、英国、BT12 6BB
- Royal Maternity Hospital, Belfast
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Birmingham、英国、B9 5SS
- Birmingham Heartlands Hospital
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Birmingham、英国、B15 2TG
- Birmingham Women's Hospital
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Birmingham、英国、B18 7QH
- Birmingham City Hospital
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Bradford、英国、BD9 6RJ
- Bradford Royal Infirmary
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Bristol、英国、BS10 5NB
- Southmead Hospital
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Bristol、英国、S2 8EG
- St Michael's Hospital
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Chertsey、英国、KT16 0PZ
- St Peters Hospital
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Chester、英国
- Countess of Chester Hospital
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Coventry、英国、CV2 2DX
- University Hospital Coventry
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Crewe、英国
- Leighton Hospital
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Derby、英国、DE22 3NE
- Derbyshire Children's Hospital
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Edinburgh、英国、EH16 4SA
- Royal Infirmary of Edinburgh
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Exeter、英国、EX2 5DW
- Royal Devon and Exeter Hospital
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Glasgow、英国、G31 2ER
- Princess Royal Maternity Hospital, Glasgow
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Glasgow、英国、G51 4TF
- Southern General Hospital
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Gloucester、英国
- Gloucestershire Royal Hosptial
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Halifax、英国、HX3 0PW
- Calderdale Royal Hospital
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Hull、英国、HU3 2JZ
- Hull Royal Infirmary
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Kettering、英国
- Kettering General Hospital
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Leeds、英国、LS9 7TF
- St James's University Hospital
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Leeds、英国、LS1 3EX
- Leeds General Infirmary
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Leicester、英国、LE1 5WW
- Leicester Royal Infirmary
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Lincoln、英国
- Lincoln County Hospital
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London、英国、SW17 0QT
- St George's Hospital
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Londonderry、英国、BT47 6SB
- Altnagelvin Area Hospital
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Middlesbrough、英国、TS4 3BW
- James Cook University Hospital
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Newcastle、英国、NE1 4LP
- Royal Victoria Infirmary
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Northampton、英国
- Northampton General Hospital
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Nottingham、英国
- Nottingham City Hospital
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Nottingham、英国
- Queen's Medical Centre
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Oxford、英国、OX3 9DU
- John Radcliffe Hospital
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Plymouth、英国
- Derriford Hospital
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Portadown、英国
- Craigavon Area Hospital
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Portsmouth、英国、PO6 3LY
- Queen Alexandra Hospital, Portsmouth
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Reading、英国、RG1 5AN
- Royal Berkshire Hospital
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Romford、英国、RM7 0AG
- Queen's Hospital, Romford
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Sheffield、英国、S10 2SF
- Jessop Wing, Sheffield
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Shrewsbury、英国、SY3 8XQ
- Royal Shrewsbury Hospital
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Southampton、英国、SO16 5YA
- Princess Anne Hospital, Southampton
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Stockton on Tees、英国、TS19 8PE
- University Hospital of North Tees
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Stoke-on-Trent、英国、ST4 6QG
- Royal Stoke University Hospital
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Sunderland、英国、SR4 7TP
- Sunderland Royal Hospital
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Sutton-in-Ashfield、英国
- King's Mill Hospital
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Swansea、英国、SA2 8QA
- Singleton Hospital
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Swindon、英国、SN3 6BB
- Great Western Hospital, Swindon
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Thornton Heath、英国、CR7 7YE
- Croydon University Hospital
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Truro、英国
- Royal Cornwall Hospital
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Upton、英国、CH49 5PE
- Arrowe Park Hospital, Wirral
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Wakefield、英国
- Pinderfields General Hospital
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Warrington、英国
- Warrington Hospital
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Wishaw、英国、ML2 0DP
- Wishaw General Hospital
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Wolverhampton、英国、WV10 0QP
- New Cross Hospital
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Worcester、英国
- Worcestershire Royal Hospital
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York、英国、YO31 8HE
- York Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Gestational age at birth <32 weeks, or birth weight less than 1,500 g
- Receiving ≤30 ml/kg/day of milk at randomisation
- Written informed parental consent is obtained
To ensure the widest applicability to preterm infants across the United Kingdom, those exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included
Exclusion Criteria:
- Infants with a severe congenital anomaly
- Infants who, in the opinion of the treating clinician, have no realistic chance of survival
- Infants who are unlikely to be traceable for follow-up at 24 months of age corrected for prematurity (for example, infants of non-United Kingdom residents)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Slower milk feed increment
Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
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实验性的：Faster milk feed increment
Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Survival without moderate or severe disability
大体时间：24 months of age corrected for prematurity
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24 months of age corrected for prematurity
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Survival to discharge home
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Incidence of necrotizing enterocolitis (Bell stage 2 or 3)
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Growth (weight and head circumference) at hospital discharge
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Measured by weight and head circumference z-scores
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Duration of parenteral feeding before hospital discharge
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Length of time in intensive care
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Length of hospital stay
大体时间：Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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合作者和调查者
调查人员
- 首席研究员：Jon Dorling, MBChB DCH MD、Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.