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Completed

NCT Number: NCT01727609

Speed of Increasing Milk Feeds Trial

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Milk feed (breast milk or formula milk)

Dietary Supplement

Primary outcomes

  1. Survival without moderate or severe disability

    Time frame: 24 months of age corrected for prematurity

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study 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

Acronym: SIFT

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2012
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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