Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

Trial ID or NCT#

NCT00005775

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Younger than 72 Hours
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 401-1000 gm* More than 12 hrs and less than 72 hrs after birth; intravenous access* Parental consent
Exclusion Criteria:
  1. * One or more major congenital anomalies* Infants meeting criteria for terminal illness* Congenital nonbacterial infection with overt signs at birth
View All Criteria
Show Less

Investigator(s)

David K. Stevenson, M.D.

View on ClinicalTrials.gov