Effect of Glutamine on Gastric Emptying and Length of Par... | NCT00213668

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

NCT00213668

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Mar 30, 2026Actual

Enrollment

Not provided

Phase

Phase 4

Conditions

Enteral Feeding

Interventions

glutamine (dipeptiven)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002Actual

Primary Completion Date

Dec 31, 2005Actual

Completion Date

Dec 31, 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Mar 30, 2026Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
glutamine (dipeptiven)	Dietary Supplement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
intestinal transit		at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
date and duration of arrest of nutrition if necessary

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

10 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Mercier, MD	CHU Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU-Rouen		Rouen		76031	France

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005973	Glutamine
C054122	alanylglutamine

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided