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Speed of Increasing Milk Feeds Trial (SIFT)

7 marzo 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2804

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 7 mesi (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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)
Integratore alimentare: Milk feed (breast milk or formula milk)
Sperimentale: 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)
Integratore alimentare: Milk feed (breast milk or formula milk)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Survival without moderate or severe disability
Lasso di tempo: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Survival to discharge home
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Oxford

Collaboratori

National Institute for Health Research, United Kingdom

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2013

Completamento primario (Effettivo)

10 maggio 2018

Completamento dello studio (Effettivo)

10 maggio 2018

Date di iscrizione allo studio

Primo inviato

11 ottobre 2012

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2012

Primo Inserito (Stima)

16 novembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 marzo 2019

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SIFT01

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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