NCT00005775

Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,433 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

Summary

This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.

Detailed description

Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings. Glutamine, which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta, is not routinely provided in neonatal parenteral nutrition preparations. This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings. Infants received a neurodevelopmental assessment by masked, certified examiners at 18-22 months postmenstrual age.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Sepsis

Interventions

Type	Name	Description
DRUG	Glutamine	Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
DRUG	Placebo	TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.

Timeline

• Start date: 1999-07-01
• Primary completion: 2000-12-01
• Completion: 2001-08-01
• First posted: 2000-06-02
• Last updated: 2015-06-08

Locations

15 sites across 1 country: United States