Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn

Phase 1

Completed

• Conditions: PPHN
• Interventions: Drug: Vardenafil; Drug: Sildenafil

• Registration Number: NCT06860399
• Lead Sponsor: Damascus University

Brief Summary

The goal of this clinical trial is to learn if drug Vardenafil works to treat pulmonary hypertension in newborns, It will also learn about the safety of Vardenafil. The main questions it aims to answer are:

Does Vardenafil lower the pulmonary hypertension in newborns? What medical problems do participants have when taking Vardenafil? Researchers will compare drug Vardenafil to drug Sildenafil to see if drug Vardenafil works better to treat pulmonary hypertension.

Participants will be divided into 2 groups , one group will take oral drug: Vardenafil and the other group will take oral drug: Sildenafil every day.

Pulmonary hypertension will be measured daily until it returns to normal. Keep a diary of the symptoms and any complications

Detailed Description

A double blind controlled trial in Children's Hospital Damascus between 5/2023 and 9/2024 on newborns up to 4 d old diagnosed with PPHN, patients were allocated randomly into one of the 2 arms of the study, group Sildenafil and group Vardenafil, both medicines administered orally, management of the patients was the same in both groups except for the investigated drug, pulmonary hypertension and resistance were measured by echo at diagnosis time and every 24 hours later on till normalization of pulmonary pressure, at the end of recruitment data was collected and analyzed to confirm the safety of Vardenafil and compare the efficacy of Vardenafil to Sildenafil

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Gestation age: 28 weeks or more

Exclusion Criteria

• Cardiac deformity, inability to administer the drug orally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vardenfil	Vardenafil	Oral Vardenafil given q12h.
Sildenafil	Sildenafil	Oral Sildenafil given q6h.

Primary Outcome Measures

Name	Time	Method
Pulmonary Hypertension	Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)	Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.
Pulmonary Resistance	Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)	Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio

Secondary Outcome Measures

Name	Time	Method
Respiratory Distress	Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4)	Respiratory rate and retractions evaluated by physical examination
Death	From day 1 of treatment till discharge from NICU ( 3 days to 90 days)

Trial Locations

Locations (1)

Children's Hospital; 🇸🇾 Damascus, Syrian Arab Republic