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Speed of Increasing Milk Feeds Trial (SIFT)

2019년 3월 7일 업데이트: University of Oxford

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

2804

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 아일랜드
      • Dublin, 아일랜드, Dublin 2
        • National Maternity Hospital, Dublin
  • 영국
      • Ashford, 영국, TN24 0LZ
        • William Harvey Hospital
      • Belfast, 영국, BT12 6BB
        • Royal Maternity Hospital, Belfast
      • Birmingham, 영국, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, 영국, B15 2TG
        • Birmingham Women's Hospital
      • Birmingham, 영국, B18 7QH
        • Birmingham City Hospital
      • Bradford, 영국, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, 영국, BS10 5NB
        • Southmead Hospital
      • Bristol, 영국, S2 8EG
        • St Michael's Hospital
      • Chertsey, 영국, KT16 0PZ
        • St Peters Hospital
      • Chester, 영국
        • Countess of Chester Hospital
      • Coventry, 영국, CV2 2DX
        • University Hospital Coventry
      • Crewe, 영국
        • Leighton Hospital
      • Derby, 영국, DE22 3NE
        • Derbyshire Children's Hospital
      • Edinburgh, 영국, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Exeter, 영국, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Glasgow, 영국, G31 2ER
        • Princess Royal Maternity Hospital, Glasgow
      • Glasgow, 영국, G51 4TF
        • Southern General Hospital
      • Gloucester, 영국
        • Gloucestershire Royal Hosptial
      • Halifax, 영국, HX3 0PW
        • Calderdale Royal Hospital
      • Hull, 영국, HU3 2JZ
        • Hull Royal Infirmary
      • Kettering, 영국
        • Kettering General Hospital
      • Leeds, 영국, LS9 7TF
        • St James's University Hospital
      • Leeds, 영국, LS1 3EX
        • Leeds General Infirmary
      • Leicester, 영국, LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln, 영국
        • Lincoln County Hospital
      • London, 영국, SW17 0QT
        • St George's Hospital
      • Londonderry, 영국, BT47 6SB
        • Altnagelvin Area Hospital
      • Middlesbrough, 영국, TS4 3BW
        • James Cook University Hospital
      • Newcastle, 영국, NE1 4LP
        • Royal Victoria Infirmary
      • Northampton, 영국
        • Northampton General Hospital
      • Nottingham, 영국
        • Nottingham City Hospital
      • Nottingham, 영국
        • Queen's Medical Centre
      • Oxford, 영국, OX3 9DU
        • John Radcliffe Hospital
      • Plymouth, 영국
        • Derriford Hospital
      • Portadown, 영국
        • Craigavon Area Hospital
      • Portsmouth, 영국, PO6 3LY
        • Queen Alexandra Hospital, Portsmouth
      • Reading, 영국, RG1 5AN
        • Royal Berkshire Hospital
      • Romford, 영국, RM7 0AG
        • Queen's Hospital, Romford
      • Sheffield, 영국, S10 2SF
        • Jessop Wing, Sheffield
      • Shrewsbury, 영국, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Southampton, 영국, SO16 5YA
        • Princess Anne Hospital, Southampton
      • Stockton on Tees, 영국, TS19 8PE
        • University Hospital of North Tees
      • Stoke-on-Trent, 영국, ST4 6QG
        • Royal Stoke University Hospital
      • Sunderland, 영국, SR4 7TP
        • Sunderland Royal Hospital
      • Sutton-in-Ashfield, 영국
        • King's Mill Hospital
      • Swansea, 영국, SA2 8QA
        • Singleton Hospital
      • Swindon, 영국, SN3 6BB
        • Great Western Hospital, Swindon
      • Thornton Heath, 영국, CR7 7YE
        • Croydon University Hospital
      • Truro, 영국
        • Royal Cornwall Hospital
      • Upton, 영국, CH49 5PE
        • Arrowe Park Hospital, Wirral
      • Wakefield, 영국
        • Pinderfields General Hospital
      • Warrington, 영국
        • Warrington Hospital
      • Wishaw, 영국, ML2 0DP
        • Wishaw General Hospital
      • Wolverhampton, 영국, WV10 0QP
        • New Cross Hospital
      • Worcester, 영국
        • Worcestershire Royal Hospital
      • York, 영국, YO31 8HE
        • York Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

7개월 이하 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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)
건강 보조 식품: Milk feed (breast milk or formula milk)
실험적: 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)
건강 보조 식품: Milk feed (breast milk or formula milk)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Survival without moderate or severe disability
기간: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

2차 결과 측정

결과 측정
측정값 설명
기간
Survival to discharge home
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Incidence of necrotizing enterocolitis (Bell stage 2 or 3)
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Growth (weight and head circumference) at hospital discharge
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Measured by weight and head circumference z-scores
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Duration of parenteral feeding before hospital discharge
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Length of time in intensive care
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Length of hospital stay
기간: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Oxford

협력자

National Institute for Health Research, United Kingdom

수사관

  • 수석 연구원: Jon Dorling, MBChB DCH MD, Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 6월 1일

기본 완료 (실제)

2018년 5월 10일

연구 완료 (실제)

2018년 5월 10일

연구 등록 날짜

최초 제출

2012년 10월 11일

QC 기준을 충족하는 최초 제출

2012년 11월 12일

처음 게시됨 (추정)

2012년 11월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 7일

마지막으로 확인됨

2018년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SIFT01

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Milk feed (breast milk or formula milk)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Oman

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다