Status:
WITHDRAWN
Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension
Lead Sponsor:
Universidad del Norte
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
Up to 10 years
Phase:
NA
Brief Summary
Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already...
Detailed Description
Persistent pulmonary hypertension of the newborn is a relatively common condition that occurs in 2 to 7/1000 live births, being higher in term and late preterm newborns, representing up to 4% of all a...
Eligibility Criteria
Inclusion
- Newborns with gestational age ≥ 34 weeks and less than 10 days old, from the delivery room, joint accommodation, surgery at the Niño Jesus Hospital and referred from other institutions with an echocardiographic diagnosis of persistent pulmonary hypertension of the newborn. A diagnosis of persistent pulmonary hypertension of the newborn will be made if any of the following criteria are identified in the absence of cyanotic congenital heart disease by echocardiography: Tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of systemic systolic blood pressure; intraventricular septum that flattens or slopes into the left ventricular cavity; bidirectional or right-to-left flow through patent ductus arteriosus; pulmonary artery acceleration time \<40 milliseconds
Exclusion
- Congenital heart disease or fatal congenital anomalies
- Oxygenation Index (IO) \> 15
- No parental consent
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04912726
Start Date
January 1 2025
End Date
December 30 2026
Last Update
December 6 2024
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