Protein Supplementation in Infants With Brain Injury
Primary Purpose
Perinatal Stroke, Hypoxic-ischemic Encephalopathy, White Matter Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increased protein
Sponsored by
About this trial
This is an interventional prevention trial for Perinatal Stroke
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Increased protein
Standard diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Head circumference
Secondary Outcome Measures
Neurodevelopmental outcome on Bayley Scales of Infant Development
Weight and length
Full Information
NCT ID
NCT01936246
First Posted
September 3, 2013
Last Updated
July 5, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
The Gerber Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01936246
Brief Title
Protein Supplementation in Infants With Brain Injury
Official Title
Protein Supplementation in Infants With Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
The Gerber Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Stroke, Hypoxic-ischemic Encephalopathy, White Matter Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Increased protein
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard diet
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Increased protein
Other Intervention Name(s)
Beneprotein or Complete Amino Acids
Primary Outcome Measure Information:
Title
Head circumference
Time Frame
12 months of age +/- 4 weeks
Secondary Outcome Measure Information:
Title
Neurodevelopmental outcome on Bayley Scales of Infant Development
Time Frame
18-22 months
Title
Weight and length
Time Frame
3, 6, 12 months of age
Other Pre-specified Outcome Measures:
Title
Blood urea nitrogen
Time Frame
10 and 30 days post study initiation
Title
CO2 from renal panel
Description
To assess for metabolic acidosis
Time Frame
10 and 30 days post study initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
3 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25616519
Citation
Merhar SL, Meinzen-Derr J, Sprague J, Wessel JJ, Leugers S, Painter J, Valentine CJ. Safety and Tolerability of Enteral Protein Supplementation for Infants With Brain Injury. Nutr Clin Pract. 2015 Aug;30(4):546-50. doi: 10.1177/0884533614567715. Epub 2015 Jan 23.
Results Reference
result
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Protein Supplementation in Infants With Brain Injury
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