Developmental Outcomes

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy
• Interventions: Other: Developmental Outcomes

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Developmental outcomes	Developmental Outcomes	A developmental assessment (Bayley-III) of children 18-20 months who already enrolled in Florida Neonatal Neurologic Network. As part of this previous study, these children were born with Hypoxic Ischemic Encephalopathy (HIE) and underwent therapeutic cooling after birth.

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