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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Enteral Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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glutamine (dipeptiven)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Days

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No