Hypoxic-Ischemic EncephalopathyFN3NCT02260271
Florida Neonatal Neurologic Network
An observational study of Hypoxic-Ischemic Encephalopathy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 weeks
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Database Entry/Biospecimen Collection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2011to Dec 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth
Who may be able to join
- 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)
Who cannot join
- Presence of lethal chromosomal abnormalities
- Severe IUGR
- Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Database Entry/Biospecimen Collection
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Database Entry/Biospecimen CollectionOther
blood, urine, buccal samples and medical data collected
| Study group | Role | What they receive |
|---|---|---|
| Database Entry/Biospecimen Collection | Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected. Receives: Other: Database Entry/Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
Measure HIE biomarker levels in blood samples obtained in infants born with HIE.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study start9 Sep 2011
- Primary completionDec 2045 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D Weiss, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260271
- Sponsor's protocol ID
- IRB201501109
- Acronym
- FN3
- Status last verified
- Feb 2026
- First submitted
- 6 Oct 2014
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Florida Neonatal Neurologic Network
- ClinicalTrials.gov ID
- NCT02260271
- Acronym / sponsor ID
- FN3 / IRB201501109
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Sep 2011 (actual)
- Primary completion
- Dec 2045 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Database Entry/Biospecimen Collection | – | Other: Database Entry/Biospecimen CollectionMedical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected. |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Presence of lethal chromosomal abnormalities
- Severe IUGR
- Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Database Entry/Biospecimen Collectionblood, urine, buccal samples and medical data collected | Other | Database Entry/Biospecimen Collection |
Primary outcome
Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
Time frame: 2 years
Measure HIE biomarker levels in blood samples obtained in infants born with HIE.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D Weiss, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.