Clinical trial NCT01727609: Speed of Increasing Milk Feeds Trial
Official title: A Multi-centre Randomised Controlled Trial of Two Speeds of Daily Increment of Milk Feeding in Very Preterm or Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Late-onset Invasive Infection
Necrotizing Enterocolitis
Keywords: Preterm
Very low birth weight
Feeding
Enteral
Milk
Sepsis
Necrotizing enterocolitis (NEC)
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2012-11-16
Enrollment: 2804
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Survival without moderate or severe disability
timeFrame: 24 months of age corrected for prematurity
Secondary outcomes:
measure: Survival to discharge home
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Incidence of necrotizing enterocolitis (Bell stage 2 or 3)
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Growth (weight and head circumference) at hospital discharge
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Duration of parenteral feeding before hospital discharge
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Length of time in intensive care
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
measure: Length of hospital stay
timeFrame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital, Dublin
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
city: Belfast
country: United Kingdom
facility: Royal Maternity Hospital, Belfast
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Bristol
country: United Kingdom
facility: St Michael's Hospital
city: Chertsey
country: United Kingdom
facility: St Peters Hospital
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Derby
country: United Kingdom
facility: Derbyshire Children's Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Princess Royal Maternity Hospital, Glasgow
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hosptial
city: Halifax
country: United Kingdom
facility: Calderdale Royal Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Portadown
country: United Kingdom
facility: Craigavon Area Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital, Portsmouth
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital, Romford
city: Sheffield
country: United Kingdom
facility: Jessop Wing, Sheffield
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital, Southampton
city: Stockton on Tees
country: United Kingdom
facility: University Hospital of North Tees
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Sutton-in-Ashfield
country: United Kingdom
facility: King's Mill Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital, Swindon
city: Thornton Heath
country: United Kingdom
facility: Croydon University Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital, Wirral
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
city: Warrington
country: United Kingdom
facility: Warrington Hospital
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
name: Jon Dorling, MBChB DCH MD
role: PRINCIPAL_INVESTIGATOR
References: