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Speed of Increasing Milk Feeds Trial (SIFT)

7. marts 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2804

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 7 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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)
Kosttilskud: Milk feed (breast milk or formula milk)
Eksperimentel: 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)
Kosttilskud: Milk feed (breast milk or formula milk)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Survival without moderate or severe disability
Tidsramme: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival to discharge home
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oxford

Samarbejdspartnere

National Institute for Health Research, United Kingdom

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2013

Primær færdiggørelse (Faktiske)

10. maj 2018

Studieafslutning (Faktiske)

10. maj 2018

Datoer for studieregistrering

Først indsendt

11. oktober 2012

Først indsendt, der opfyldte QC-kriterier

12. november 2012

Først opslået (Skøn)

16. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2019

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SIFT01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med For tidlig fødsel

Kliniske forsøg med Milk feed (breast milk or formula milk)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Djibouti

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner