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Speed of Increasing Milk Feeds Trial (SIFT)

7 de março de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2804

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 7 meses (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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)
Suplemento dietético: Milk feed (breast milk or formula milk)
Experimental: 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)
Suplemento dietético: Milk feed (breast milk or formula milk)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Survival without moderate or severe disability
Prazo: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Survival to discharge home
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Oxford

Colaboradores

National Institute for Health Research, United Kingdom

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2013

Conclusão Primária (Real)

10 de maio de 2018

Conclusão do estudo (Real)

10 de maio de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

11 de outubro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de novembro de 2012

Primeira postagem (Estimativa)

16 de novembro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de março de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de março de 2019

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SIFT01

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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