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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213668

Enrollment

Unknown

Registered

2005-09-21

Start date

2002-04-01

Completion date

2005-12-31

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding

Keywords

glutamine, premature neonate, gastric emptying

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.

Interventions

DIETARY_SUPPLEMENTglutamine (dipeptiven)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Days to 10 Days

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

Design outcomes

Primary

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

Secondary

Measure	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	—
age of total enteral nutrition	—
age at the end of hospitalization	—
variation of cholescystokinin and gastrin postprandial concentration	at day 0 and day 14

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAnne Mercier, MD

CHU Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026