Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn (PPHN)

March 3, 2025 updated by: Damascus University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestation age: 28 weeks or more

Exclusion Criteria:

  • Cardiac deformity, inability to administer the drug orally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vardenfil
Oral Vardenafil given q12h.
Drug: Vardenafil
Oral Vardenafil
Other Names:
  • fast fix
Active Comparator: Sildenafil
Oral Sildenafil given q6h.
Drug: Sildenafil
Oral Sildenafil
Other Names:
  • viagra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Hypertension
Time Frame: 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 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 Resistance
Time Frame: 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
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Distress
Time Frame: 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
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)
Death
Time Frame: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)
From day 1 of treatment till discharge from NICU ( 3 days to 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: prof. Srour, Children's Hospital Damascus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Pediatrics-2025-01
  • 20230501 (Other Identifier: Damascus University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

When summary data are published

IPD Sharing Access Criteria

researchers working on the same topic interested in conducting the same study in different conditions or comparing the treatment to a different drug can contact the researcher by email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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