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

This study is currently recruiting participants.

Verified by University Hospital, Rouen, September 2005

First Received: September 13, 2005 Last Updated: December 10, 2007 History of Changes

Sponsor:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213668

Purpose

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.

Condition	Intervention	Phase
Enteral Feeding	Dietary Supplement: glutamine (dipeptiven)	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

Resource links provided by NLM:

Drug Information available for: Glutamine

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Study Start Date:

April 2002

Eligibility

Ages Eligible for Study:	up to 10 Days
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213668

Contacts

Contact: Anne Mercier, MD

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

anne.mercier@ch-avranches-granville.fr

Locations

France
CHU-Rouen	Recruiting
Rouen, France, 76031
Contact: Anne Mercier, MD 00332888265 anne.mercier@ch-avranches.granville.fr
Principal Investigator: Anne Mercier, MD

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Anne Mercier, MD

CHU Rouen

More Information

No publications provided

Study ID Numbers:	2000/111 HP
Study First Received:	September 13, 2005
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00213668 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

glutamine
premature neonate
gastric emptying

ClinicalTrials.gov processed this record on November 30, 2009