Premature Birth Clinical Trial
— SIFTOfficial 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
| NCT number | NCT01727609 |
| Other study ID # | SIFT01 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Est. completion date | May 10, 2018 |
| Verified date | July 2018 |
| Source | University of Oxford |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2804 |
| Est. completion date | May 10, 2018 |
| Est. primary completion date | May 10, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 32 Weeks |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | National Maternity Hospital, Dublin | Dublin | |
| United Kingdom | William Harvey Hospital | Ashford | |
| United Kingdom | Royal Maternity Hospital, Belfast | Belfast | |
| United Kingdom | Birmingham City Hospital | Birmingham | |
| United Kingdom | Birmingham Heartlands Hospital | Birmingham | |
| United Kingdom | Birmingham Women's 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oxford | National Institute for Health Research, United Kingdom |
Ireland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival without moderate or severe disability | 24 months of age corrected for prematurity | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | Growth (weight and head circumference) at hospital discharge | 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. | |
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. |
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