Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Shandong University

Status: Unknown

Conditions: Persistent Pulmonary Hypertension of the Newborn

Treatments: Drug: Tadalafil Tablets; Drug: Bosentan Tablets; Drug: Sildenafil Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04379180

2020_PPHN_001

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Treatment(bosentan, sildenafil and tadalafil)

Treatment:

Drug: Sildenafil Tablet

Drug: Bosentan Tablets

Drug: Tadalafil Tablets