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Speed of Increasing Milk Feeds Trial (SIFT)

7 mars 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

2804

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 7 mois (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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)
Complément alimentaire: Milk feed (breast milk or formula milk)
Expérimental: 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)
Complément alimentaire: Milk feed (breast milk or formula milk)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Survival without moderate or severe disability
Délai: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Survival to discharge home
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oxford

Collaborateurs

National Institute for Health Research, United Kingdom

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2013

Achèvement primaire (Réel)

10 mai 2018

Achèvement de l'étude (Réel)

10 mai 2018

Dates d'inscription aux études

Première soumission

11 octobre 2012

Première soumission répondant aux critères de contrôle qualité

12 novembre 2012

Première publication (Estimation)

16 novembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mars 2019

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SIFT01

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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