Speed of Increasing Milk Feeds Trial (SIFT)

This study is ongoing, but not recruiting participants.
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, 2015
Last verified: August 2015
  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 ]

Enrollment: 2806
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

  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:
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, 2015
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
Enterocolitis, Necrotizing
Premature Birth
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on August 26, 2015