Growth and Feeding Tolerance in Premature Infants (NCT07409038) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Growth and Feeding Tolerance in Premature Infants
Pakistan96 participantsStarted 2026-02-01
Plain-language summary
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
Who can participate
Age range
28 Weeks – 31 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:
* Preterm infants born at 28-31+6 weeks' gestation and/or birth weight1000-1500g.
* Exclusively receiving mother's own milk or donor human milk.
* No major congenital anomalies, severe sepsis, or NEC at enrollment.
* Parental/guardian consent
Exclusion Criteria:
* Extremely pre-term infants
* Infants with congenital gastrointestinal malformations or metabolic disorders.
* Infants with confirmed necrotizing enterocolitis(NEC)Stage II/III or intestinal perforation before enrollment (as these cases indicate significant gastrointestinal morbidity that may interfere with feeding tolerance and growth assessment).
* Infants whose parents decline participation.
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
weight gain
Timeframe: 2 to 3 months
2
● Linear growth & head circumference
Timeframe: 2 to 3 months
Trial details
NCT IDNCT07409038
SponsorChildren's Hospital and Institute of Child Health, Multan