Speed of Increasing Milk Feeds Trial (SIFT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Oxford
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01727609
First received: October 11, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Premature Birth
Late-onset Invasive Infection
Necrotizing Enterocolitis
Dietary Supplement: Milk feed (breast milk or formula milk)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Survival without moderate or severe disability [ Time Frame: 24 months of age corrected for prematurity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    Measured by weight and head circumference z-scores

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: February 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
Dietary Supplement: Milk feed (breast milk or formula milk)
Experimental: 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)
Dietary Supplement: Milk feed (breast milk or formula milk)

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727609

Contacts
Contact: SIFT Trial Coordinator 01865 617 919 sift@npeu.ox.ac.uk
Contact: Ursula Bowler 01865 289 749 ursula.bowler@npeu.ox.ac.uk

Locations
Ireland
National Maternity Hospital, Dublin Recruiting
Dublin, Ireland, Dublin 2
Contact: Anne Twomey         
Principal Investigator: Anne Twomey         
United Kingdom
William Harvey Hospital Recruiting
Ashford, United Kingdom, TN24 0LZ
Contact: Vimal Vasu         
Principal Investigator: Vimal Vasu         
Royal Maternity Hospital, Belfast Recruiting
Belfast, United Kingdom, BT12 6BB
Contact: Stanley Craig         
Principal Investigator: Stanley Craig         
Birmingham City Hospital Recruiting
Birmingham, United Kingdom, B18 7QH
Contact: Shanmugasundaram Sivakumar         
Principal Investigator: Shanmugasundaram Sivakumar         
Principal Investigator: Fiona Chambers         
Birmingham Women's Hospital Recruiting
Birmingham, United Kingdom, B15 2TG
Contact: Gemma Holder         
Principal Investigator: Gemma Holder         
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Imogen Storey         
Principal Investigator: Imogen Storey         
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Sunita Seal         
Principal Investigator: Sunita Seal         
St Michael's Hospital Recruiting
Bristol, United Kingdom, S2 8EG
Contact: Pamela Cairns         
Principal Investigator: Pamela Cairns         
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Paul Mannix         
Principal Investigator: Paul Mannix         
St Peters Hospital Recruiting
Chertsey, United Kingdom, KT16 0PZ
Contact: Peter Reynolds         
Principal Investigator: Peter Reynolds         
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Richard DeBoer         
Principal Investigator: Richard DeBoer         
Derbyshire Children's Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: John McIntyre         
Principal Investigator: John McIntyre         
Principal Investigator: Mal Ratnayaka         
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Ben Stenson         
Principal Investigator: Ben Stenson         
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: David Bartle         
Principal Investigator: David Bartle         
Princess Royal Maternity Hospital, Glasgow Recruiting
Glasgow, United Kingdom, G31 2ER
Contact: Helen Mactier         
Principal Investigator: Helen Mactier         
Southern General Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Colin Peters         
Principal Investigator: Colin Peters         
Calderdale Royal Hospital Recruiting
Halifax, United Kingdom, HX3 0PW
Contact: Eilean Crosbie         
Principal Investigator: Eilean Crosbie         
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Hassan Gaili         
Principal Investigator: Hassan Gaili         
Leeds General Infirmary Recruiting
Leeds, United Kingdom, LS1 3EX
Contact: Kathryn Johnson         
Principal Investigator: Kathryn Johnson         
St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Kathryn Johnson         
Principal Investigator: Kathryn Johnson         
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Elaine Boyle         
Principal Investigator: Elaine Boyle         
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Nigel Kennea         
Principal Investigator: Nigel Kennea         
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Mithilesh Lal         
Principal Investigator: Mithilesh Lal         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Nick Embleton         
Principal Investigator: Nick Embleton         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Kenny McCormick         
Principal Investigator: Kenny McCormick         
Queen Alexandra Hospital, Portsmouth Recruiting
Portsmouth, United Kingdom, PO6 3LY
Contact: Tim Scorrer         
Principal Investigator: Tim Scorrer         
Royal Berkshire Hospital Recruiting
Reading, United Kingdom, RG1 5AN
Contact: Nicola Pritchard         
Principal Investigator: Nicola Pritchard         
Queen's Hospital, Romford Recruiting
Romford, United Kingdom, RM7 0AG
Contact: Khalid Mannan         
Principal Investigator: Khalid Mannan         
Principal Investigator: Wilson Lopez         
Jessop Wing, Sheffield Recruiting
Sheffield, United Kingdom, S10 2SF
Contact: Robert Coombs         
Principal Investigator: Robert Coombs         
Royal Shrewsbury Hospital Recruiting
Shrewsbury, United Kingdom, SY3 8XQ
Contact: Sanjeev Deshpande         
Principal Investigator: Sanjeev Deshpande         
Princess Anne Hospital, Southampton Recruiting
Southampton, United Kingdom, SO16 5YA
Contact: Alison Leaf         
Principal Investigator: Alison Leaf         
University Hospital of North Tees Recruiting
Stockton on Tees, United Kingdom, TS19 8PE
Contact: Sundaram Janakiraman         
Principal Investigator: Sundaram Janakiraman         
University Hospital of North Staffordshire Recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Contact: e Abbott         
Principal Investigator: Lee Abbott         
Sunderland Royal Hospital Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Majd Abu-Harb         
Principal Investigator: Majd Abu-Harb         
Singleton Hospital Recruiting
Swansea, United Kingdom, SA2 8QA
Contact: ujoy Banerjee         
Principal Investigator: Sujoy Banerjee         
Great Western Hospital, Swindon Recruiting
Swindon, United Kingdom, SN3 6BB
Contact: Girish Gowda         
Principal Investigator: Girish Gowda         
Croydon University Hospital Recruiting
Thornton Heath, United Kingdom, CR7 7YE
Contact: John Chang         
Principal Investigator: John Chang         
Arrowe Park Hospital, Wirral Recruiting
Upton, United Kingdom, CH49 5PE
Contact: Adrian Hughes         
Principal Investigator: Adrian Hughes         
Wishaw General Hospital Recruiting
Wishaw, United Kingdom, ML2 0DP
Contact: Samuel Ibhanesebhor         
Principal Investigator: Samuel Ibhanesebhor         
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Alyson Skinner         
Principal Investigator: Alyson Skinner         
York Hospital Recruiting
York, United Kingdom, YO31 8HE
Contact: Bill McGuire         
Principal Investigator: Bill McGuire         
Principal Investigator: Guy Millman         
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Jon Dorling, MBChB DCH MD School of Medicine, University of Nottingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01727609     History of Changes
Other Study ID Numbers: SIFT01
Study First Received: October 11, 2012
Last Updated: August 7, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

Keywords provided by University of Oxford:
Preterm
Very low birth weight
Feeding
Enteral
Milk
Sepsis
Necrotizing enterocolitis (NEC)

Additional relevant MeSH terms:
Enterocolitis
Premature Birth
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014