Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-26

Study Completion Date

2023-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent Pulmonary Hypertension of the Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment(bosentan, sildenafil and tadalafil)

Bosentan Tablets

Intervention Type DRUG

2mg/kg, bid

Sildenafil Tablet

Intervention Type DRUG

1mg/kg, q6h/q8h

Tadalafil Tablets

Intervention Type DRUG

1mg/kg, qd

Interventions

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Bosentan Tablets

2mg/kg, bid

Intervention Type DRUG

Sildenafil Tablet

1mg/kg, q6h/q8h

Intervention Type DRUG

Tadalafil Tablets

1mg/kg, qd

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No