UnknownNot Applicable

Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

China500 participantsStarted 2020-04-26

Plain-language summary

The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.

Who can participate

Age range28 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: postnatal age ≤ 28 days; * Patients have been diagnosed with PPHN; * Bosentan, sildenafil and/or tadalafil used as part of regular treatment. * Parental written consent Exclusion Criteria: * Expected survival time less than the treatment cycle; * Major congenital malformations; * Undergoing surgery within the first week of life; * Receiving other systemic trial drug therapy; * Other factors that the researcher considers unsuitable for inclusion.

What they're measuring

Oxygenation index

Timeframe: The first 72 hours of the initial treatment

The change of hemodynamics

Timeframe: Through study completion, an average of 5 days

Trial details

NCT IDNCT04379180

SponsorShandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-26

View on ClinicalTrials.gov More Persistent Pulmonary Hypertension of the Newborn trials