Protein Supplementation in Infants With Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Perinatal Stroke Hypoxic-ischemic Encephalopathy White Matter Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Increased protein

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.

Group Type EXPERIMENTAL

Increased protein

Intervention Type DIETARY_SUPPLEMENT

Standard diet

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Increased protein

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beneprotein or Complete Amino Acids

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

Minimum Eligible Age

2 Days

Maximum Eligible Age

3 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No