Clinical Trial: Protein Supplementation in Infants With Brain Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protein Supplementation in Infants With Brain Injury

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 Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Head circumference [ Time Frame: 12 months of age +/- 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neurodevelopmental outcome on Bayley Scales of Infant Development [ Time Frame: 18-22 months ]
  • Weight and length [ Time Frame: 3, 6, 12 months of age ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: September 3, 2013
Date Started: August 2012
Date Completion:
Last Updated: April 13, 2016
Last Verified: April 2016