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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213668
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Enteral Feeding
Dietary Supplement: glutamine (dipeptiven)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • gastric emptying [ Time Frame: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product ]

Secondary Outcome Measures:
  • intestinal transit [ Time Frame: 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 ]

Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213668

Locations
France
CHU-Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Anne Mercier, MD CHU Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213668     History of Changes
Other Study ID Numbers: 2000/111/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
glutamine
premature neonate
gastric emptying

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 01, 2014