Hypoxic-ischemic Encephalopathy, Perinatal Stroke, White Matter Injury
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTIncreased protein
Sponsors
The Gerber Foundation
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Days to 3 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Head circumference | 12 months of age +/- 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Neurodevelopmental outcome on Bayley Scales of Infant Development | 18-22 months |
| Weight and length | 3, 6, 12 months of age |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood urea nitrogen | 10 and 30 days post study initiation | — |
| CO2 from renal panel | 10 and 30 days post study initiation | To assess for metabolic acidosis |
Countries
United States
Outcome results
None listed