Clinical trial NCT01936246: Protein Supplementation in Infants With Brain Injury
Official title: Protein Supplementation in Infants With Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Stroke
Hypoxic-ischemic Encephalopathy
White Matter Injury
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2013-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Head circumference
timeFrame: 12 months of age +/- 4 weeks
Secondary outcomes:
measure: Neurodevelopmental outcome on Bayley Scales of Infant Development
timeFrame: 18-22 months
measure: Weight and length
timeFrame: 3, 6, 12 months of age
Other outcomes:
measure: Blood urea nitrogen
timeFrame: 10 and 30 days post study initiation
measure: CO2 from renal panel
timeFrame: 10 and 30 days post study initiation
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie Merhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merhar SL, Meinzen-Derr J, Sprague J, Wessel JJ, Leugers S, Painter J, Valentine CJ. Safety and Tolerability of Enteral Protein Supplementation for Infants With Brain Injury. Nutr Clin Pract. 2015 Aug;30(4):546-50. doi: 10.1177/0884533614567715. Epub 2015 Jan 23.