An interventional study of Milk feed (breast milk or formula milk) in Premature Birth, Late-onset Invasive Infection and Necrotizing Enterocolitis, sponsored by University of Oxford. Completed at 57 sites in 2 countries. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
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.
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's enrollment of 2,804 is above the median of 100 across 123 interventional studies indexed under Enterocolitis.
Browse Enterocolitis studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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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:
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)
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)
Survival without moderate or severe disability
Time frame: 24 months of age corrected for prematurity
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
Measured by weight and head circumference z-scores
Time frame: Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks.
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.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Oxford