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NCT02264808 Clinical Trial

Developmental Outcomes

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02264808
Other study ID # IRB201400699
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2014
Est. completion date December 3, 2018

Study information
Verified date January 2020
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

Description:

Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The developmental assessment tool that will be used is called the Bayley Scales of Infant and Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will then be compared to the child's HIE biomarkers concentrations already obtained at birth.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date December 3, 2018
Est. primary completion date December 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Months to 20 Months
Eligibility Inclusion Criteria:

- children already enrolled in IRB#504-2011

- 18-20 months of age

Exclusion Criteria:

- none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Developmental Outcomes
A Bayley-III developmental assessment will be performed study subjects at age 18-20 months

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida American Heart Association

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age Compare Developmental Outcomes to HIE Biomarker concentrations at birth 2 years
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