Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

• Status: Completed
• Trial end date: 2001-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Amino-acid, glucose, and electrolyte solution

Criteria

Inclusion Criteria:

• 401-1000 gm

• More than 12 hrs and less than 72 hrs after birth; intravenous access

• Parental consent

Exclusion Criteria:

• One or more major congenital anomalies

• Infants meeting criteria for terminal illness

• Congenital nonbacterial infection with overt signs at birth