Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Protein Supplementation in Infants With Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01936246
First received: September 3, 2013
Last updated: August 22, 2014
Last verified: September 2013
  Purpose

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 Intervention
Perinatal Stroke
Hypoxic-ischemic Encephalopathy
White Matter Injury
Dietary Supplement: Increased protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protein Supplementation in Infants With Brain Injury

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Head circumference [ Time Frame: 12 months of age +/- 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopmental outcome on Bayley Scales of Infant Development [ Time Frame: 18-22 months ] [ Designated as safety issue: No ]
  • Weight and length [ Time Frame: 3, 6, 12 months of age ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Blood urea nitrogen [ Time Frame: 10 and 30 days post study initiation ] [ Designated as safety issue: Yes ]
  • CO2 from renal panel [ Time Frame: 10 and 30 days post study initiation ] [ Designated as safety issue: Yes ]
    To assess for metabolic acidosis


Estimated Enrollment: 24
Study Start Date: August 2012
Estimated Study Completion Date: January 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936246

Locations
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
Investigators
Principal Investigator: Stephanie Merhar, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01936246     History of Changes
Other Study ID Numbers: CCHMCProtein
Study First Received: September 3, 2013
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Injuries
Brain Ischemia
Hypoxia-Ischemia, Brain
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Hypoxia, Brain
Nervous System Diseases
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014