Neokare Safety and Tolerability Assessment in Neonates With GI Problems (NCT05293353) | Clinical Trial Compass
UnknownNot Applicable
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
United Kingdom50 participantsStarted 2022-06-09
Plain-language summary
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP containing feed in high risk babies.
Delivery of adequate nutritional intake is one of the great challenges in the care of newborn infants, particularly those born preterm or with gastrointestinal problems. Whilst there are recognised benefits of human milk, a diet of exclusive human milk may not meet the nutritional demands of the infant. To close this gap, breast milk fortifier (BMF) is typically added to human milk. However, addition of BMF may be associated with gastrointestinal disturbance, possibly due to the fact that it contains CMP.
This research study is to test the tolerability and safety of a new human milk-based BMF in neonates with gastrointestinal problems. It is hoped that this may provide an opportunity for high risk infants, to receive the benefits of human milk whilst minimising the risks reported to be associated with CMP.
Eligible infants will be those in whom nutritional supplementation of breast is deemed clinically necessary, a weight of greater than 1.0kg at the time of starting fortifier and at least one of:
* previous gastrointestinal surgery
* congenital gastrointestinal anomaly
* medically treated gastrointestinal disease
* previously suspected intolerance of CMP based breast milk fortifier in the absence of other gastrointestinal disease
Infants will be started on human milk-based BMF once they are tolerating 100 mls per kilo per day of human breast milk. The human milk-based fortifier will be commenced at half the recommended dose for 48 hours then increase to full strength. This will be continued until the infant reaches 44 weeks corrected gestational age, or until such time as they are deemed to no longer require the additional nutrition.
Who can participate
Age range
44 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Current weight greater than ≥ 1.5kg (this will reduce to current weight of ≥ 1.0kg following midpoint review if no safety concerns
. Deemed by attending clinician that fortification of breast milk is desirable either to meet nutritional requirements or optimise growth
. Exclusive maternal or donor breast milk feeding (at time of starting fortifier)
. At least one of the following diagnostic criteria:
. Any previous gastrointestinal tract surgery. This may include but is not limited:
. Medically treated gastrointestinal disease including but not limited to necrotising enterocolitis (based on nationally agreed case definitions), meconium ileus of prematurity (clinical diagnosis), milk curd obstruction (clinical diagnosis)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days of feed intolerance
Timeframe: At 38 weeks postmenstrual age (an average of 8 weeks after initial surgery/gastrointestinal disturbance)
Trial details
NCT IDNCT05293353
SponsorUniversity Hospital Southampton NHS Foundation Trust
. Previously suspected intolerance of cow's milk protein-based breast milk fortifier in the absence of other gastrointestinal disease (clinical diagnosis)