Clinical trial NCT06860399: Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn
Official title: The Effectiveness of Vardenafil Vs Sildenafil for The Treatment of Pulmonary Hypertension of the Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: PPHN
Keywords: PPHN
Sildenafil
Vardenafil
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 55
Sex: ALL
Minimum age (years): 24
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Gestation age: 28 weeks or more

Exclusion Criteria:

* Cardiac deformity, inability to administer the drug orally

Primary outcomes:
measure: Pulmonary Hypertension
timeFrame: 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)
measure: Pulmonary Resistance
timeFrame: 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 outcomes:
measure: Respiratory Distress
timeFrame: 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)
measure: Death
timeFrame: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Children's Hospital
Study officials:
affiliation: Children's Hospital Damascus
name: prof. Srour
role: STUDY_CHAIR
References: