NCT02264808

Developmental Outcomes

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Months – 20 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
OTHER	Developmental Outcomes	A Bayley-III developmental assessment will be performed study subjects at age 18-20 months

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2014-10-15
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States