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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
NCT02260271 |
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Date of registration:
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06/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Florida Neonatal Neurologic Network
FN3 |
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Scientific title:
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Florida Neonatal Neurologic Network |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT02260271 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael D Weiss, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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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))
Age minimum:
1 Day
Age maximum:
3 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoxic-Ischemic Encephalopathy
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Intervention(s)
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Other: Database Entry/Biospecimen Collection
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Primary Outcome(s)
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Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
[Time Frame: 2 years]
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Secondary ID(s)
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IRB201501109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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