Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2804 participants
INTERVENTIONAL
2013-06-30
2018-05-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Milk feed (breast milk or formula milk)
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)
Milk feed (breast milk or formula milk)
Interventions
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Milk feed (breast milk or formula milk)
Eligibility Criteria
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Inclusion Criteria
* 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 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)
32 Weeks
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Jon Dorling, MBChB DCH MD
Role: PRINCIPAL_INVESTIGATOR
Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
Locations
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National Maternity Hospital, Dublin
Dublin, , Ireland
William Harvey Hospital
Ashford, , United Kingdom
Royal Maternity Hospital, Belfast
Belfast, , United Kingdom
Birmingham Women's Hospital
Birmingham, , United Kingdom
Birmingham City Hospital
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
St Michael's Hospital
Bristol, , United Kingdom
St Peters Hospital
Chertsey, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Leighton Hospital
Crewe, , United Kingdom
Derbyshire Children's Hospital
Derby, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Princess Royal Maternity Hospital, Glasgow
Glasgow, , United Kingdom
Southern General Hospital
Glasgow, , United Kingdom
Gloucestershire Royal Hosptial
Gloucester, , United Kingdom
Calderdale Royal Hospital
Halifax, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
St George's Hospital
London, , United Kingdom
Altnagelvin Area Hospital
Londonderry, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Craigavon Area Hospital
Portadown, , United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Queen's Hospital, Romford
Romford, , United Kingdom
Jessop Wing, Sheffield
Sheffield, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Princess Anne Hospital, Southampton
Southampton, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
King's Mill Hospital
Sutton in Ashfield, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Great Western Hospital, Swindon
Swindon, , United Kingdom
Croydon University Hospital
Thornton Heath, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Arrowe Park Hospital, Wirral
Upton, , United Kingdom
Pinderfields General Hospital
Wakefield, , United Kingdom
Warrington Hospital
Warrington, , United Kingdom
Wishaw General Hospital
Wishaw, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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Other Identifiers
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SIFT01
Identifier Type: -
Identifier Source: org_study_id
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