Effect of Protein Intake on Preterm Infant Body Composition (NCT02353013) | Clinical Trial Compass
CompletedNot Applicable
Effect of Protein Intake on Preterm Infant Body Composition
United States36 participantsStarted 2014-12
Plain-language summary
The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.
Who can participate
Age range
1 Minute – 1 Year
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:
* Premature infants born less than 32 weeks EGA
* Growth that is appropriate for gestational age (AGA)
* Admitted to OU Children's NICU, inborn or outborn
* Receiving enteral feedings \<100 mL/kg/day
* Hemodynamically stable
Exclusion Criteria:
* Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
* Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
* Inborn errors of metabolism
* History of necrotizing enterocolitis Bell stage III
* Cerebrospinal fluid indwelling shunt (affects body composition measurements)
* Expected death prior to 36 weeks EGA (the end of the study period)
* Inability to meet Pea Pod® requirements for the first measurement
* On vasopressor medications
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.