Speed of Increasing Milk Feeds Trial
- Conditions
- Necrotizing EnterocolitisPremature BirthLate-onset Invasive Infection
- Interventions
- Dietary Supplement: Milk feed (breast milk or formula milk)
- Registration Number
- NCT01727609
- Lead Sponsor
- University of Oxford
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2804
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Slower milk feed increment Milk feed (breast milk or formula milk) Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) Faster milk feed increment Milk feed (breast milk or formula milk) Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
- Primary Outcome Measures
Name Time Method Survival without moderate or severe disability 24 months of age corrected for prematurity
- Secondary Outcome Measures
Name Time Method Incidence of necrotizing enterocolitis (Bell stage 2 or 3) 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 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 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 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
Length of time in intensive care Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. Survival to discharge home 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) 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 Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Trial Locations
- Locations (57)
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Queen Alexandra Hospital, Portsmouth
🇬🇧Portsmouth, United Kingdom
Altnagelvin Area Hospital
🇬🇧Londonderry, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Jessop Wing, Sheffield
🇬🇧Sheffield, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Arrowe Park Hospital, Wirral
🇬🇧Upton, United Kingdom
Warrington Hospital
🇬🇧Warrington, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Craigavon Area Hospital
🇬🇧Portadown, United Kingdom
Queen's Hospital, Romford
🇬🇧Romford, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Princess Anne Hospital, Southampton
🇬🇧Southampton, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, United Kingdom
University Hospital of North Tees
🇬🇧Stockton on Tees, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
King's Mill Hospital
🇬🇧Sutton-in-Ashfield, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Croydon University Hospital
🇬🇧Thornton Heath, United Kingdom
Great Western Hospital, Swindon
🇬🇧Swindon, United Kingdom
Pinderfields General Hospital
🇬🇧Wakefield, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, United Kingdom
York Hospital
🇬🇧York, United Kingdom
National Maternity Hospital, Dublin
🇮🇪Dublin, Ireland
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
William Harvey Hospital
🇬🇧Ashford, United Kingdom
Royal Maternity Hospital, Belfast
🇬🇧Belfast, United Kingdom
Birmingham City Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, 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
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Derbyshire Children's Hospital
🇬🇧Derby, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Princess Royal Maternity Hospital, Glasgow
🇬🇧Glasgow, United Kingdom
Gloucestershire Royal Hosptial
🇬🇧Gloucester, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Kettering General Hospital
🇬🇧Kettering, United Kingdom
Southern General Hospital
🇬🇧Glasgow, United Kingdom