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Trial record 1 of 2 for:    Florida Neonatal Neurologic Network
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Florida Neonatal Neurologic Network (FN3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260271
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2014
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment
Hypoxic-Ischemic Encephalopathy Other: Database Entry/Biospecimen Collection

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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Florida Neonatal Neurologic Network
Study Start Date : September 2011
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
blood, urine, buccal samples and medical data collected


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
blood, urine and buccal samples

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth
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))
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260271


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Michael D Weiss, MD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02260271    
Other Study ID Numbers: IRB201501109
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Central Nervous System Diseases
Nervous System Diseases
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
 Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Hypoxia
Signs and Symptoms, Respiratory