Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Persistent Pulmonary Hypertension of the Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04379180
• Other study ID #: 2020_PPHN_001
• Status: Not yet recruiting
• Start date: April 26, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2020
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 30, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of the Newborn

Intervention

Drug:
• Bosentan Tablets
2mg/kg, bid
• Sildenafil Tablet
1mg/kg, q6h/q8h
• Tadalafil Tablets
1mg/kg, qd

Locations

Country	Name	City	State
China	West China Second University Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation index	Oxygenation index=(fraction of inspired oxygen*mean airway pressure)/the partial pressure of arterial oxygen	The first 72 hours of the initial treatment
Primary	The change of hemodynamics	Pulmonary artery pressure (mmHg); Alveolar-arterial gradient (mmHg)	Through study completion, an average of 5 days
Secondary	Duration of hospitalization	Duration of initial therapy	Within the first 28 days of patients' life
Secondary	Death	Death in the first 28 days of life	Within the first 28 days of patients' life
Secondary	Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 5 days
Secondary	Sequelae of PPHN	Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc	Through study completion and a 6-month visit
Secondary	The need of extra support	Besides the initial therapy (bosentan, sildenafil and/or tadalafil), other support such as inhaled nitric oxide (iNO), inotropic agents or Extracorporeal Membrane Oxygenation (ECMO)	Through study completion, an average of 5 days
Secondary	Pulse oxygen saturation	Pulse oxygen saturation(%)	The first 72 hours of the initial treatment