Protein Supplementation in Infants With Brain Injury

July 5, 2017 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Head circumference
Time Frame: 12 months of age +/- 4 weeks
12 months of age +/- 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopmental outcome on Bayley Scales of Infant Development
Time Frame: 18-22 months
18-22 months
Weight and length
Time Frame: 3, 6, 12 months of age
3, 6, 12 months of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood urea nitrogen
Time Frame: 10 and 30 days post study initiation
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
10 and 30 days post study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

The Gerber Foundation

Investigators

  • Principal Investigator: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHMCProtein

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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