Protein Supplementation in Infants With Brain Injury

Hypoxic-ischemic Encephalopathy Clinical Trial

Official title:

Protein Supplementation in Infants With Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936246
• Other study ID #: CCHMCProtein
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: July 5, 2017
• Start date: August 2012
• Est. completion date: February 2016

Study information

• Verified date: July 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-ischemic Encephalopathy
• Perinatal Stroke
• White Matter Injury
• Wounds and Injuries

Intervention

Dietary Supplement:
• Increased protein

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood urea nitrogen		10 and 30 days post study initiation
Other	CO2 from renal panel	To assess for metabolic acidosis	10 and 30 days post study initiation
Primary	Head circumference		12 months of age +/- 4 weeks
Secondary	Neurodevelopmental outcome on Bayley Scales of Infant Development		18-22 months
Secondary	Weight and length		3, 6, 12 months of age