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Speed of Increasing Milk Feeds Trial (SIFT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727609
First Posted: November 16, 2012
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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. ]
    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. ]
  • 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. ]

Enrollment: 2804
Study Start Date: February 2013
Estimated Study Completion Date: January 31, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727609


  Show 57 Study Locations
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:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: DOI: 10.1186/s12887-017-0794-z

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01727609     History of Changes
Other Study ID Numbers: SIFT01
First Submitted: October 11, 2012
First Posted: November 16, 2012
Last Update Posted: May 5, 2017
Last Verified: May 2017

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