Florida Neonatal Neurologic Network | NCT02260271

Studies
Florida Neonatal Neurologic Network

NCT02260271

Sponsor

University of Florida

Status

Enrolling by invitation

Last Update Posted

Feb 11, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hypoxic-Ischemic Encephalopathy

Interventions

Database Entry/Biospecimen Collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2011Actual

Primary Completion Date

Dec 2045Estimated

Completion Date

Dec 2045Estimated

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Oct 6, 2014

First Posted Date

Oct 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed with the data and samples will receive Institutional Review Board (IRB) approval.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Database Entry/Biospecimen Collection	Other	blood, urine, buccal samples and medical data collected	Database Entry/Biospecimen Collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Weeks

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael D Weiss, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32610	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020925	Hypoxia-Ischemia, Brain

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided