Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
- Conditions
- Infant, NewbornInfant, Low Birth WeightSepsisInfant, Small for Gestational AgeInfant, Premature
- Interventions
- Drug: Placebo
- Registration Number
- NCT00005775
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1433
- 401-1000 gm
- More than 12 hrs and less than 72 hrs after birth; intravenous access
- Parental consent
- One or more major congenital anomalies
- Infants meeting criteria for terminal illness
- Congenital nonbacterial infection with overt signs at birth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) Glutamine Glutamine TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)
- Primary Outcome Measures
Name Time Method Death or late-onset sepsis At hospital discharge
- Secondary Outcome Measures
Name Time Method Growth (days to reach 1500 grams) At hospital discharge Number of days on parenteral nutrition At hospital discharge Levels of pro-inflammatory cytokines In the perinatal period Episodes of late-onset sepsis At hospital discharge Neurodevelopmental outcome 18-22 months corrrected age Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intolerance At hospital discharge Necrotizing Enterocolitis At hospital discharge Length of stay in NICU At hospital discharge
Trial Locations
- Locations (15)
Emory University
🇺🇸Atlanta, Georgia, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of California at San Diego
🇺🇸San Diego, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University
🇺🇸Palo Alto, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
RTI International
🇺🇸Durham, North Carolina, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States