Protein Supplementation in Infants With Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Protein Supplementation in Infants With Brain Injury

Conditions
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Perinatal Stroke, Hypoxic-ischemic Encephalopathy, White Matter Injury

Intervention / Treatment
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* Dietary Supplement: Increased protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 3 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased protein<br>Full term infants will be on 4 g/kg/day of protein. Preterm infants will be on 4.5 g/kg/day of protein until term corrected age. Beneprotein powder will be used; if this is not tolerated, Complete Amino Acids will be used. Max protein will be 30 g/day. Increased protein will be given until 12 months corrected age. | Dietary Supplement: Increased protein<br> <br> * Other names: Beneprotein or Complete Amino Acids;|
| No Intervention: Standard diet<br>Infants will be given a usual diet. If infants in this arm have poor growth, protein or caloric supplementation may be given per the discretion of the clinical team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head circumference |  | 12 months of age +/- 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental outcome on Bayley Scales of Infant Development |  | 18-22 months | 
| Weight and length |  | 3, 6, 12 months of age |