Status:
UNKNOWN
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN
Lead Sponsor:
Shandong University
Collaborating Sponsors:
West China Second University Hospital
Conditions:
Persistent Pulmonary Hypertension of the Newborn
Eligibility:
All Genders
Up to 28 years
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04379180
Start Date
April 26 2020
End Date
May 30 2023
Last Update
May 7 2020
Active Locations (1)
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1
West China Second University Hospital
Chengdu, Sichuan, China, 610041