Sepsis Clinical Trial
Official title:
Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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