PPHN
Conditions
Keywords
PPHN, Sildenafil, Vardenafil
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
Interventions
DRUGVardenafil
Oral Vardenafil
DRUGSildenafil
Oral Sildenafil
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 96 Hours
Healthy volunteers
No
Inclusion criteria
* Gestation age: 28 weeks or more
Exclusion criteria
* Cardiac deformity, inability to administer the drug orally
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Syria
Outcome results
None listed