Developmental Outcomes

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy

• Registration Number: NCT02264808
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Study Start: 2014-11
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• children already enrolled in IRB#504-2011
• 18-20 months of age

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age	2 years	Compare Developmental Outcomes to HIE Biomarker concentrations at birth

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States