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NCT00213668 Clinical Trial

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

Enteral Feeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213668
Other study ID # 2000/111/HP
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated June 17, 2013
Start date April 2002

Study information
Verified date June 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A to 10 Days
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• glutamine (dipeptiven)

Locations
Country Name City State
France CHU-Rouen Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary gastric emptying at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
Secondary intestinal transit at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
Secondary date and duration of arrest of nutrition if necessary
Secondary age of total enteral nutrition
Secondary age at the end of hospitalization
Secondary variation of cholescystokinin and gastrin postprandial concentration at day 0 and day 14
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