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

U

University Hospital, Rouen

Status and phase

Completed
Phase 4

Conditions

Enteral Feeding

Treatments

Dietary Supplement: glutamine (dipeptiven)

Study type

Interventional

Funder types

Other

Identifiers

NCT00213668
2000/111/HP

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 10 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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