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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
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Stroke

Eligibility Criteria

2 Days - 3 Weeks (Child)All SexesDoes not accept healthy volunteers

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

First Posted
September 3, 2013
Last Updated
July 5, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
The Gerber Foundation
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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
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Protein Supplementation in Infants With Brain Injury

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