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

June 17, 2013 updated by: University Hospital, Rouen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • CHU-Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
intestinal transit
Time Frame: at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
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
at day 0 and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Anne Mercier, MD, CHU Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000/111/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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