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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 10, 2007

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

gastric emptying [ Time Frame: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00213668 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

intestinal transit at day1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
date and duration of arrest of nutrition if necessary
age of total enteral nutrition
age at the end of hospitalization
variation of cholescystokinine and gastrine postprandial concentration at day 0 and day 14

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Enteral Feeding

Intervention ^ICMJE

Dietary Supplement: glutamine (dipeptiven)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 10 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Anne Mercier, MD

02-32-88-80-97 ext 02-33-89-42-62

anne.mercier@ch-avranches-granville.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00213668

Responsible Party

Study ID Numbers ^ICMJE

2000/111 HP

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anne Mercier, MD

CHU Rouen

Information Provided By

University Hospital, Rouen

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP