Back to resultsEffect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Primary Purpose
Enteral Feeding
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
glutamine (dipeptiven)
Sponsored by
About this trial
This is an interventional prevention trial for Enteral Feeding focused on measuring glutamine, premature neonate, gastric emptying
Eligibility 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
Sites / Locations
- CHU-Rouen
Outcomes
Primary Outcome Measures
gastric emptying
Secondary Outcome Measures
intestinal transit
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
Full Information
NCT ID
NCT00213668
First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00213668
Brief Title
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Official Title
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding
Keywords
glutamine, premature neonate, gastric emptying
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
glutamine (dipeptiven)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
intestinal transit
Time Frame
at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
Title
date and duration of arrest of nutrition if necessary
Title
age of total enteral nutrition
Title
age at the end of hospitalization
Title
variation of cholescystokinin and gastrin postprandial concentration
Time Frame
at day 0 and day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
10 Days
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Mercier, MD
Organizational Affiliation
CHU Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU-Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
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