Overview

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