Speed of Increasing Milk Feeds Trial (SIFT)

March 7, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2804

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 2
        • National Maternity Hospital, Dublin
  • United Kingdom
      • Ashford, United Kingdom, TN24 0LZ
        • William Harvey Hospital
      • Belfast, United Kingdom, BT12 6BB
        • Royal Maternity Hospital, Belfast
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, United Kingdom, B15 2TG
        • Birmingham Women's Hospital
      • Birmingham, United Kingdom, B18 7QH
        • Birmingham City Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Bristol, United Kingdom, S2 8EG
        • St Michael's Hospital
      • Chertsey, United Kingdom, KT16 0PZ
        • St Peters Hospital
      • Chester, United Kingdom
        • Countess of Chester Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Crewe, United Kingdom
        • Leighton Hospital
      • Derby, United Kingdom, DE22 3NE
        • Derbyshire Children's Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom, G31 2ER
        • Princess Royal Maternity Hospital, Glasgow
      • Glasgow, United Kingdom, G51 4TF
        • Southern General Hospital
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hosptial
      • Halifax, United Kingdom, HX3 0PW
        • Calderdale Royal Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Kettering, United Kingdom
        • Kettering General Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln, United Kingdom
        • Lincoln County Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • Londonderry, United Kingdom, BT47 6SB
        • Altnagelvin Area Hospital
      • Middlesbrough, United Kingdom, Ts4 3Bw
        • James Cook University Hospital
      • Newcastle, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Northampton, United Kingdom
        • Northampton General Hospital
      • Nottingham, United Kingdom
        • Nottingham City Hospital
      • Nottingham, United Kingdom
        • Queen's Medical Centre
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Portadown, United Kingdom
        • Craigavon Area Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital, Portsmouth
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Romford, United Kingdom, RM7 0AG
        • Queen's Hospital, Romford
      • Sheffield, United Kingdom, S10 2SF
        • Jessop Wing, Sheffield
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Southampton, United Kingdom, SO16 5YA
        • Princess Anne Hospital, Southampton
      • Stockton on Tees, United Kingdom, TS19 8PE
        • University Hospital of North Tees
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Sutton-in-Ashfield, United Kingdom
        • King's Mill Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital, Swindon
      • Thornton Heath, United Kingdom, CR7 7YE
        • Croydon University Hospital
      • Truro, United Kingdom
        • Royal Cornwall Hospital
      • Upton, United Kingdom, CH49 5PE
        • Arrowe Park Hospital, Wirral
      • Wakefield, United Kingdom
        • Pinderfields General Hospital
      • Warrington, United Kingdom
        • Warrington Hospital
      • Wishaw, United Kingdom, ML2 0DP
        • Wishaw General Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worcester, United Kingdom
        • Worcestershire Royal Hospital
      • York, United Kingdom, YO31 8HE
        • York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Dietary supplement: Milk feed (breast milk or formula milk)
Experimental: 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)
Dietary supplement: Milk feed (breast milk or formula milk)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival without moderate or severe disability
Time Frame: 24 months of age corrected for prematurity
24 months of age corrected for prematurity

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to discharge home
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

National Institute for Health Research, United Kingdom

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIFT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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