Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Information source: University Hospital, Rouen
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Enteral Feeding
Intervention: glutamine (dipeptiven) (Dietary Supplement)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Rouen Official(s) and/or principal investigator(s):
Anne Mercier, MD, Principal Investigator, Affiliation: CHU Rouen
Overall contact:
Anne Mercier, MD, Phone: 02-32-88-80-97, Ext: 02-33-89-42-62, Email: anne.mercier@ch-avranches-granville.fr
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.
Clinical Details
Official title: Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: gastric emptying
Secondary outcome: intestinal transitdate 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
Eligibility
Minimum age: N/A.
Maximum age: 10 Days.
Gender(s): 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
Locations and Contacts
Anne Mercier, MD, Phone: 02-32-88-80-97, Ext: 02-33-89-42-62, Email: anne.mercier@ch-avranches-granville.fr
CHU-Rouen, Rouen 76031, France; Recruiting
Anne Mercier, MD, Phone: 00332888265, Email: anne.mercier@ch-avranches.granville.fr
Anne Mercier, MD, Principal Investigator
Additional Information
Starting date: April 2002
Last updated: December 10, 2007
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