NCT02264808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4.1 years

First QC Date

October 6, 2014

Last Update Submit

January 14, 2020

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Developmental Outcomes

Interventions

Developmental OutcomesOTHER

A Bayley-III developmental assessment will be performed study subjects at age 18-20 months

Developmental outcomes

Eligibility Criteria

Age18 Months - 20 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 18-20 months of age born with Hypoxic Ischemic Encephalopathy (HIE)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers will be compared to developmental outcomes, however these blood samples were already obtained through IRB#504-2011

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael D Weiss, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 15, 2014

Study Start

November 1, 2014

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)