Protein Supplementation in Infants With Brain Injury

Not Applicable

Completed

• Conditions: Perinatal Stroke; White Matter Injury; Hypoxic-ischemic Encephalopathy
• Interventions: Dietary Supplement: Increased protein

• Registration Number: NCT01936246
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-06
• Primary Completion: 2014-03
• Study Completion: 2016-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increased protein	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.

Primary Outcome Measures

Name	Time	Method
Head circumference	12 months of age +/- 4 weeks

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental outcome on Bayley Scales of Infant Development	18-22 months
Weight and length	3, 6, 12 months of age

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States