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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,433
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, 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
...and 5 more locations
Death or late-onset sepsis
Time frame: At hospital discharge
Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intolerance
Time frame: At hospital discharge
Necrotizing Enterocolitis
Time frame: At hospital discharge
Episodes of late-onset sepsis
Time frame: At hospital discharge
Growth (days to reach 1500 grams)
Time frame: At hospital discharge
Number of days on parenteral nutrition
Time frame: At hospital discharge
Length of stay in NICU
Time frame: At hospital discharge
Neurodevelopmental outcome
Time frame: 18-22 months corrrected age
Levels of pro-inflammatory cytokines
Time frame: In the perinatal period
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