Protein Supplementation in Infants With Brain Injury



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:7/7/2017
Start Date:August 2012
End Date:February 2016

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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.


Inclusion Criteria:

- Infants admitted to the NICU at CCHMC

- Known or suspected brain injury

- Parental consent obtained

- At least 48 hours of age at the time of randomization

Exclusion Criteria:

- Congenital or posthemorrhagic hydrocephalus

- Major congenital brain malformations

- Congenital gastrointestinal malformations or Bell Stage III NEC

- Inborn errors of metabolism

- Chromosomal abnormalities

- Significant cardiac disease
We found this trial at
1
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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