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Protein Supplementation in Infants With Brain Injury

NCT01936246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-06

No results posted yet for this study

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.

Conditions

  • Perinatal Stroke
  • Hypoxic-ischemic Encephalopathy
  • White Matter Injury

Interventions

DIETARY_SUPPLEMENT

Increased protein

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Stephanie Merhar, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
3 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-03-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936246 on ClinicalTrials.gov