Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

Phase 4

Completed

• Conditions: Enteral Feeding

• Registration Number: NCT00213668
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gastric emptying	at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product

Secondary Outcome Measures

Name	Time	Method
age of total enteral nutrition
date and duration of arrest of nutrition if necessary
variation of cholescystokinin and gastrin postprandial concentration	at day 0 and day 14
intestinal transit	at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
age at the end of hospitalization

Trial Locations

Locations (1)

CHU-Rouen; 🇫🇷 Rouen, France