Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates (NCT00213668) | Clinical Trial Compass
CompletedPhase 4
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
FranceStarted 2002-04
Plain-language summary
This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.
Who can participate
Age range
2 Days – 10 Days
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 neonates aged 30-33 weeks of gestational age
* Aged at least 2 days and no more than 10 days
* Free of acute illness
* Written informed consent is obtained from the parent prior to enrolment.
Exclusion Criteria:
* Premature infants with respiratory (fraction of inspired oxygen \[FiO2\] \> 30%), or cardiovascular, liver, intestinal or acute diseases
* Premature infants with congenital syndrome
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
gastric emptying
Timeframe: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product