Status:
COMPLETED
Registry of Preterm Newborns With Severe Pulmonary Hypertension
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Mallinckrodt
Conditions:
Pulmonary Hypertension
Preterm Infant
Eligibility:
All Genders
Up to 45 years
Brief Summary
The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).
Detailed Description
There is a lack of consensus on the role of inhaled nitric oxide (iNO) therapy and other pulmonary vasodilators for the treatment of severe pulmonary hypertension (PH) in premature newborns (\<34 week...
Eligibility Criteria
Inclusion
- Premature newborns 23-34 weeks gestation
- Echocardiographic evidence showing systemic or suprasystemic levels of PH, or \> 5% difference in pre-post ductal saturation if echo is not available.
- Fraction of inspired oxygen (FiO2) \>0.60 in the first 72 hours after birth
Exclusion
- None
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 2 2022
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT03310346
Start Date
August 1 2017
End Date
July 2 2022
Last Update
March 6 2023
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045