Protein Supplementation in Infants With Brain Injury

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01936246

Run by

Children's Hospital Medical Center, Cincinnati

People needed

24

Starts

2012-08-01

Expected to finish

2016-02-01

Last updated by the study team

2017-07-06

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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