Premature BirthSIFTNCT01727609
Speed of Increasing Milk Feeds Trial
A study testing Milk feed (breast milk or formula milk) in people with Premature Birth and Late-onset Invasive Infection, run by University of Oxford at 57 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Premature Birth, Late-onset Invasive Infection, Necrotizing Enterocolitis
- What is being tested?
- Milk feed (breast milk or formula milk)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,804 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Jun 2013to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United Kingdom56 sites
William Harvey Hospital
Ashford, TN24 0LZ
Royal Maternity Hospital, Belfast
Belfast, BT12 6BB
Birmingham Women's Hospital
Birmingham, B15 2TG
Birmingham City Hospital
Birmingham, B18 7QH
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Bradford Royal Infirmary
Bradford, BD9 6RJ
Southmead Hospital
Bristol, BS10 5NB
St Michael's Hospital
Bristol, S2 8EG
St Peters Hospital
Chertsey, KT16 0PZ
Countess of Chester Hospital
Chester
University Hospital Coventry
Coventry, CV2 2DX
Leighton Hospital
Crewe
Derbyshire Children's Hospital
Derby, DE22 3NE
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Princess Royal Maternity Hospital, Glasgow
Glasgow, G31 2ER
Southern General Hospital
Glasgow, G51 4TF
Gloucestershire Royal Hosptial
Gloucester
Calderdale Royal Hospital
Halifax, HX3 0PW
Hull Royal Infirmary
Hull, HU3 2JZ
Kettering General Hospital
Kettering
Leeds General Infirmary
Leeds, LS1 3EX
St James's University Hospital
Leeds, LS9 7TF
Leicester Royal Infirmary
Leicester, LE1 5WW
Lincoln County Hospital
Lincoln
St George's Hospital
London, SW17 0QT
Altnagelvin Area Hospital
Londonderry, BT47 6SB
James Cook University Hospital
Middlesbrough, TS4 3BW
Royal Victoria Infirmary
Newcastle, NE1 4LP
Northampton General Hospital
Northampton
Nottingham City Hospital
Nottingham
Queen's Medical Centre
Nottingham
John Radcliffe Hospital
Oxford, OX3 9DU
Derriford Hospital
Plymouth
Craigavon Area Hospital
Portadown
Queen Alexandra Hospital, Portsmouth
Portsmouth, PO6 3LY
Royal Berkshire Hospital
Reading, RG1 5AN
Queen's Hospital, Romford
Romford, RM7 0AG
Jessop Wing, Sheffield
Sheffield, S10 2SF
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
Princess Anne Hospital, Southampton
Southampton, SO16 5YA
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Sunderland Royal Hospital
Sunderland, SR4 7TP
King's Mill Hospital
Sutton in Ashfield
Singleton Hospital
Swansea, SA2 8QA
Great Western Hospital, Swindon
Swindon, SN3 6BB
Croydon University Hospital
Thornton Heath, CR7 7YE
Royal Cornwall Hospital
Truro
Arrowe Park Hospital, Wirral
Upton, CH49 5PE
Pinderfields General Hospital
Wakefield
Warrington Hospital
Warrington
Wishaw General Hospital
Wishaw, ML2 0DP
New Cross Hospital
Wolverhampton, WV10 0QP
Worcestershire Royal Hospital
Worcester
York Hospital
York, YO31 8HE
About this study
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
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.
Read more
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.
- Being tested
- Milk feed (breast milk or formula milk)
- Keywords
- Preterm, Very low birth weight, Feeding, Enteral, Milk, Sepsis, Necrotizing enterocolitis (NEC)
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk feed (breast milk or formula milk)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Slower milk feed increment | Active comparator | Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) Receives: Dietary Supplement: Milk feed (breast milk or formula milk) |
| Faster milk feed increment | Experimental | Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) Receives: Dietary Supplement: Milk feed (breast milk or formula milk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without moderate or severe disability
Measured: 24 months of age corrected for prematurity
Secondary outcomes (8)
Survival to discharge home
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured by weight and head circumference z-scores
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startJun 2013
- Primary completion10 May 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jon Dorling, MBChB DCH MD, Principal investigator, Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727609
- Sponsor's protocol ID
- SIFT01
- Acronym
- SIFT
- Status last verified
- Jul 2018
- First submitted
- 11 Oct 2012
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01727609
- Acronym / sponsor ID
- SIFT / SIFT01
- Keywords
- Preterm, Very low birth weight, Feeding, Enteral, Milk, Sepsis, Necrotizing enterocolitis (NEC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,804 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jun 2013 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slower milk feed increment | Active comparator | Dietary Supplement: 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 | Experimental | Dietary Supplement: 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) |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk feed (breast milk or formula milk) | Dietary supplement | Faster milk feed increment, Slower milk feed increment |
Primary outcome
Survival without moderate or severe disability
Time frame: 24 months of age corrected for prematurity
8 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Dorling, MBChB DCH MD principal investigator
Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk feed (breast milk or formula milk) in people with Premature Birth and Late-onset Invasive Infection, run by University of Oxford at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without moderate or severe disability (time frame: 24 months of age corrected for prematurity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.