Protein Supplementation in Infants With Brain Injury
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|ClinicalTrials.gov Identifier: NCT01936246|
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : July 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Stroke Hypoxic-ischemic Encephalopathy White Matter Injury||Dietary Supplement: Increased protein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Protein Supplementation in Infants With Brain Injury|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||February 2016|
Experimental: 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.
Dietary Supplement: Increased protein
Other Name: Beneprotein or Complete Amino Acids
No Intervention: 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.
- Head circumference [ Time Frame: 12 months of age +/- 4 weeks ]
- Neurodevelopmental outcome on Bayley Scales of Infant Development [ Time Frame: 18-22 months ]
- Weight and length [ Time Frame: 3, 6, 12 months of age ]
- Blood urea nitrogen [ Time Frame: 10 and 30 days post study initiation ]
- CO2 from renal panel [ Time Frame: 10 and 30 days post study initiation ]To assess for metabolic acidosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936246
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Stephanie Merhar, MD||Children's Hospital Medical Center, Cincinnati|