Hypoxic-ischemic Encephalopathy Clinical Trial
Official title:
Protein Supplementation in Infants With Brain Injury
To date, few studies have been done regarding nutrition supplementation in infants with brain
injury. Therefore, the investigators are proposing to study the effects of protein
supplementation in this group of babies. The investigators will recruit 24 infants with brain
injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the
Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon
diagnosis, the investigators will obtain consent from the parents for participation in the
study, then randomly assign the baby to one of two groups - an increased protein group and a
control group. Both groups of infants will be monitored to ensure no adverse effects occur
due to the supplementation.
Protein supplementation will continue for the first 12 months of age. Growth parameters, such
as weight, length, and head circumference, will be measured while the infant is the NICU.
Head circumference will be measured in the investigators outpatient clinic at three, six, and
12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes
using the Bayley Scales of Infant Development. The investigators hypothesize that infants who
receive the additional protein will demonstrate increased head growth and improved
neurodevelopmental outcomes.
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