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

NCT00213668 | Completed Phase 4

• 1 other identifier: 2000/111/HP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding

Keywords

glutamine; premature neonate; gastric emptying

Outcome Measures

Primary Outcomes (1)

• gastric emptying

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

Secondary Outcomes (5)

• 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

• age of total enteral nutrition

• age at the end of hospitalization

• variation of cholescystokinin and gastrin postprandial concentration

  at day 0 and day 14

Interventions

glutamine (dipeptiven) DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 2 Days - 10 Days
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Premature infants with respiratory (fraction of inspired oxygen \[FiO2\] \> 30%), or cardiovascular, liver, intestinal or acute diseases
• Premature infants with congenital syndrome

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU-Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Glutamine; alanylglutamine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Anne Mercier, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2002
• Primary Completion: December 31, 2005
• Study Completion: December 31, 2005
• Last Updated: March 30, 2026

Record last verified: 2013-06

Locations

FR (1)