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

Damascus University

Status and phase: Completed; Phase 2; Phase 1

Conditions: PPHN

Treatments: Drug: Vardenafil; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT06860399

UDMS-Pediatrics-2025-01

20230501 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 55 patients

Sex: All

Ages: 24 to 96 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestation age: 28 weeks or more

Exclusion criteria

• Cardiac deformity, inability to administer the drug orally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Vardenfil

Experimental group

Description:

Oral Vardenafil given q12h.

Treatment:

Drug: Vardenafil

Sildenafil

Active Comparator group

Description:

Oral Sildenafil given q6h.

Treatment:

Drug: Sildenafil