Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting (NCT03522558) | Clinical Trial Compass
UnknownNot Applicable
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
United States200 participantsStarted 2018-07-01
Plain-language summary
The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.
Who can participate
Age range
2 Years
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:
* Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)
Exclusion Criteria:
* short bowel syndrome,
* requiring parenteral nutrition (PN)
* active cancer
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
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Timeframe: 4 months corrected gestational age (CGA)
2
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Timeframe: 8 months corrected gestational age (CGA)
3
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Timeframe: 12 months corrected gestational age (CGA)
4
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Timeframe: 1 year corrected gestational age (CGA)
Trial details
NCT IDNCT03522558
SponsorThe University of Texas Health Science Center, Houston