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Speed of Increasing Milk Feeds Trial (SIFT)

7 mars 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

2804

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 7 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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)
Kosttillskott: Milk feed (breast milk or formula milk)
Experimentell: 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)
Kosttillskott: Milk feed (breast milk or formula milk)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Survival without moderate or severe disability
Tidsram: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Survival to discharge home
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Oxford

Samarbetspartners

National Institute for Health Research, United Kingdom

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2013

Primärt slutförande (Faktisk)

10 maj 2018

Avslutad studie (Faktisk)

10 maj 2018

Studieregistreringsdatum

Först inskickad

11 oktober 2012

Först inskickad som uppfyllde QC-kriterierna

12 november 2012

Första postat (Uppskatta)

16 november 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 mars 2019

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SIFT01

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