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Protein Supplementation in Infants With Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01936246
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : July 6, 2017
The Gerber Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Perinatal Stroke Hypoxic-ischemic Encephalopathy White Matter Injury Dietary Supplement: Increased protein Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Neurodevelopmental outcome on Bayley Scales of Infant Development [ Time Frame: 18-22 months ]
  2. Weight and length [ Time Frame: 3, 6, 12 months of age ]

Other Outcome Measures:
  1. Blood urea nitrogen [ Time Frame: 10 and 30 days post study initiation ]
  2. CO2 from renal panel [ Time Frame: 10 and 30 days post study initiation ]
    To assess for metabolic acidosis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01936246

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
The Gerber Foundation
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Principal Investigator: Stephanie Merhar, MD Children's Hospital Medical Center, Cincinnati
Publications of Results:
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01936246    
Other Study ID Numbers: CCHMCProtein
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain