Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn

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.

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.