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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Dublin、アイルランド、Dublin 2
- National Maternity Hospital, Dublin
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Ashford、イギリス、TN24 0LZ
- William Harvey Hospital
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Belfast、イギリス、BT12 6BB
- Royal Maternity Hospital, Belfast
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Birmingham、イギリス、B9 5SS
- Birmingham Heartlands Hospital
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Birmingham、イギリス、B15 2TG
- Birmingham Women's Hospital
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Birmingham、イギリス、B18 7QH
- Birmingham City Hospital
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Bradford、イギリス、BD9 6RJ
- Bradford Royal Infirmary
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Bristol、イギリス、BS10 5NB
- Southmead Hospital
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Bristol、イギリス、S2 8EG
- St Michael's Hospital
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Chertsey、イギリス、KT16 0PZ
- St Peters Hospital
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Chester、イギリス
- Countess of Chester Hospital
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Coventry、イギリス、CV2 2DX
- University Hospital Coventry
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Crewe、イギリス
- Leighton Hospital
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Derby、イギリス、DE22 3NE
- Derbyshire Children's Hospital
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Edinburgh、イギリス、EH16 4SA
- Royal Infirmary of Edinburgh
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Exeter、イギリス、EX2 5DW
- Royal Devon and Exeter Hospital
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Glasgow、イギリス、G31 2ER
- Princess Royal Maternity Hospital, Glasgow
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Glasgow、イギリス、G51 4TF
- Southern General Hospital
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Gloucester、イギリス
- Gloucestershire Royal Hosptial
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Halifax、イギリス、HX3 0PW
- Calderdale Royal Hospital
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Hull、イギリス、HU3 2JZ
- Hull Royal Infirmary
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Kettering、イギリス
- Kettering General Hospital
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Leeds、イギリス、LS9 7TF
- St James's University Hospital
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Leeds、イギリス、LS1 3EX
- Leeds General Infirmary
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Leicester、イギリス、LE1 5WW
- Leicester Royal Infirmary
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Lincoln、イギリス
- Lincoln County Hospital
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London、イギリス、SW17 0QT
- St George's Hospital
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Londonderry、イギリス、BT47 6SB
- Altnagelvin Area Hospital
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Middlesbrough、イギリス、TS4 3BW
- James Cook University Hospital
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Newcastle、イギリス、NE1 4LP
- Royal Victoria Infirmary
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Northampton、イギリス
- Northampton General Hospital
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Nottingham、イギリス
- Nottingham City Hospital
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Nottingham、イギリス
- Queen's Medical Centre
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Oxford、イギリス、OX3 9DU
- John Radcliffe Hospital
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Plymouth、イギリス
- Derriford Hospital
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Portadown、イギリス
- Craigavon Area Hospital
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Portsmouth、イギリス、PO6 3LY
- Queen Alexandra Hospital, Portsmouth
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Reading、イギリス、RG1 5AN
- Royal Berkshire Hospital
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Romford、イギリス、RM7 0AG
- Queen's Hospital, Romford
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Sheffield、イギリス、S10 2SF
- Jessop Wing, Sheffield
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Shrewsbury、イギリス、SY3 8XQ
- Royal Shrewsbury Hospital
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Southampton、イギリス、SO16 5YA
- Princess Anne Hospital, Southampton
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Stockton on Tees、イギリス、TS19 8PE
- University Hospital of North Tees
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Stoke-on-Trent、イギリス、ST4 6QG
- Royal Stoke University Hospital
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Sunderland、イギリス、SR4 7TP
- Sunderland Royal Hospital
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Sutton-in-Ashfield、イギリス
- King's Mill Hospital
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Swansea、イギリス、SA2 8QA
- Singleton Hospital
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Swindon、イギリス、SN3 6BB
- Great Western Hospital, Swindon
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Thornton Heath、イギリス、CR7 7YE
- Croydon University Hospital
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Truro、イギリス
- Royal Cornwall Hospital
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Upton、イギリス、CH49 5PE
- Arrowe Park Hospital, Wirral
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Wakefield、イギリス
- Pinderfields General Hospital
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Warrington、イギリス
- Warrington Hospital
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Wishaw、イギリス、ML2 0DP
- Wishaw General Hospital
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Wolverhampton、イギリス、WV10 0QP
- New Cross Hospital
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Worcester、イギリス
- Worcestershire Royal Hospital
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York、イギリス、YO31 8HE
- York Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Survival without moderate or severe disability
時間枠：24 months of age corrected for prematurity
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24 months of age corrected for prematurity
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Survival to discharge home
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jon Dorling, MBChB DCH MD、Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。