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Speed of Increasing Milk Feeds Trial (SIFT)

7 de marzo de 2019 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2804

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 7 meses (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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)

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Survival to discharge home
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2013

Finalización primaria (Actual)

10 de mayo de 2018

Finalización del estudio (Actual)

10 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

11 de octubre de 2012

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2012

Publicado por primera vez (Estimar)

16 de noviembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de marzo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

7 de marzo de 2019

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SIFT01

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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