Developmental Outcomes

University of Florida

Status: Completed

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Other: Developmental Outcomes

Study type: Observational

Funder types: Other

Identifiers

NCT02264808

IRB201400699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 20 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

21 participants in 1 patient group

Developmental outcomes

Description:

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.

Treatment:

Other: Developmental Outcomes