Speed of Increasing Milk Feeds Trial (SIFT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 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: November 12, 2012
Last verified: November 2012
  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.

This study will compare two different rates of increase of milk feeds, one 'fast' and one 'slow', both within rates currently used in UK neonatal units with the aim to find out if either rate 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 NHS, including costs.

The study will be led by an established team of researchers who have run similar studies before, and will use an established network of neonatal units that have taken part in previous studies. Investigators are confident that there will be enough families wishing to take part in this study.


Condition Intervention
Premature Birth
Nosocomial Infections
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 Rates of Daily Increment of Enteral Feeding to Prevent Late-onset Invasive Infection in Very Preterm or Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Survival without serious disability [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of microbiologically-confirmed or clinically strongly-suspected late-onset invasive infection [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: Yes ]
  • Incidence of necrotizing enterocolitis [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: Yes ]
  • Time to reaching full milk feeds (defined as 150 ml/kg/day) [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Growth at discharge [ Time Frame: Participants will be followed from enrolment to 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

  • Total duration of parenteral feeding before discharge from hospital [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Number of days spent in intensive care [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: Participants will be followed from enrolment to 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: Slow milk feed increment
Increase milk feeds by 18 ml/kg/day until full milk feeds of 150 ml/kg/day are achieved.
Dietary Supplement: Milk feed (breast milk or formula milk)
Experimental: Fast milk feed increment
Increase milk feeds by 30 ml/kg/day until full milk feeds of 150ml/kg/day are achieved
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 less than 32 weeks, or less than 1500 g birth weight
  • Receiving less than 24 ml/kg/day of milk at time of randomisation
  • Written informed consent is obtained

Exclusion Criteria:

  • Infants with severe congenital anomalies
  • Infants not likely to survive or be traced for follow-up (e.g. non-UK 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: Elizabeth Bosiak 01865 617 919 elizabeth.bosiak@npeu.ox.ac.uk
Contact: Ursula Bowler 01865 289 749 ursula.bowler@npeu.ox.ac.uk

Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Jon Dorling, MBChB DCH MD Nottingham University Hospitals NHS Trust
  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: November 12, 2012
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
Sepsis
Feeding
Enteral
Milk

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

ClinicalTrials.gov processed this record on July 20, 2014