Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Sepsis
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW) infants, Prematurity, Glutamine, Total parenteral nutrition, Nutrition, Very low birth weight (VLBW) infants
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.
Interventions
DRUGGlutamine
Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
DRUGPlacebo
TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
Sponsors
National Center for Research Resources (NCRR)
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or late-onset sepsis | At hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| Levels of pro-inflammatory cytokines | In the perinatal period |
| Episodes of late-onset sepsis | At hospital discharge |
| Growth (days to reach 1500 grams) | At hospital discharge |
| Neurodevelopmental outcome | 18-22 months corrrected age |
| Length of stay in NICU | At hospital discharge |
| 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 |
| Number of days on parenteral nutrition | At hospital discharge |
Countries
United States
Outcome results
None listed