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OpenTrials
Completed

NCT Number: NCT00213668

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

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.

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Key information

Conditions

Enteral Feeding Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU-Rouen

Rouen, 76031, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine (dipeptiven)

Dietary Supplement

Primary outcomes

  1. gastric emptying

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

Secondary outcomes

  1. intestinal transit

    Time frame: at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product

  2. date and duration of arrest of nutrition if necessary

  3. age of total enteral nutrition

  4. age at the end of hospitalization

  5. variation of cholescystokinin and gastrin postprandial concentration

    Time frame: at day 0 and day 14

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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