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 range2 Days – 10 Days

SexALL

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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

What they're measuring

gastric emptying

Timeframe: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product

Trial details

NCT IDNCT00213668

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-12-31

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