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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Minor Primary and study completion dates: Dec 31, 2005v8
  2. Minor Trial status: Recruiting to Completed
    • Site details revised
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Minor Interventions: glutamine (dipeptiven) (Behavioral) to glutamine (dipeptiven) (Dietary Supplement)v5
  5. Notable Primary endpoint revised
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (5)
    • Site contact updated
    v4
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  1. Minor Eligibility criteria revisedv3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00213668
Lead Sponsor University Hospital, Rouen
Conditions
(from sponsor)
Enteral Feeding
Related terms Premature Birth
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov