NCT02260271

Brief Summary

Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
239mo left

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress43%
Sep 2011Dec 2045

Study Start

First participant enrolled

September 9, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
31.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2045

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

34.3 years

First QC Date

October 6, 2014

Last Update Submit

February 10, 2026

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)

    Measure HIE biomarker levels in blood samples obtained in infants born with HIE.

    2 years

Study Arms (1)

Database Entry/Biospecimen Collection

Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.

Other: Database Entry/Biospecimen Collection

Interventions

Database Entry/Biospecimen CollectionOTHER

blood, urine, buccal samples and medical data collected

Database Entry/Biospecimen Collection

Eligibility Criteria

Age1 Day - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth

You may qualify if:

  • Gestational Age greater than or equal to 35 weeks gestation
  • Birth weight greater than or equal to 1.8 kg
  • Less than or equal to 6 hours since insult occurred
  • Severe hypoxic-ischemic encepholopathy (HIE)

You may not qualify if:

  • Presence of lethal chromosomal abnormalities
  • Severe IUGR
  • Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))

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

blood, urine and buccal samples

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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 9, 2014

Study Start

September 9, 2011

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

December 1, 2045

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

US(1)