Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Speed of Increasing Milk Feeds Trial (SIFT)

7. mars 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2804

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 7 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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)
Kosttilskudd: Milk feed (breast milk or formula milk)
Eksperimentell: 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)
Kosttilskudd: Milk feed (breast milk or formula milk)

Hva måler studien?

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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oxford

Samarbeidspartnere

National Institute for Health Research, United Kingdom

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2013

Primær fullføring (Faktiske)

10. mai 2018

Studiet fullført (Faktiske)

10. mai 2018

Datoer for studieregistrering

Først innsendt

11. oktober 2012

Først innsendt som oppfylte QC-kriteriene

12. november 2012

Først lagt ut (Anslag)

16. november 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2019

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SIFT01

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på For tidlig fødsel

Kliniske studier på Milk feed (breast milk or formula milk)

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Ethiopia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere