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Completed

NCT Number: NCT06860399

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

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Key information

Conditions

PPHN

Age range

24 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Hospital

Damascus, 011, Syria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestation age: 28 weeks or more

Exclusion criteria

  • Cardiac deformity, inability to administer the drug orally

Treatment and study plan

Vardenafil

Drug

Oral Vardenafil

Other names: fast fix

Sildenafil

Drug

Oral Sildenafil

Other names: viagra

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. Death

    Time frame: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Acronym: PPHN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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