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.
Study Type
OBSERVATIONAL
Enrollment
500
West China Second University Hospital
Chengdu, Sichuan, China
Oxygenation index
Oxygenation index=(fraction of inspired oxygen\*mean airway pressure)/the partial pressure of arterial oxygen
Time frame: The first 72 hours of the initial treatment
The change of hemodynamics
* Pulmonary artery pressure (mmHg) * Alveolar-arterial gradient (mmHg)
Time frame: Through study completion, an average of 5 days
Duration of hospitalization
Duration of initial therapy
Time frame: Within the first 28 days of patients' life
Death
Death in the first 28 days of life
Time frame: Within the first 28 days of patients' life
Adverse events
Drug-related adverse events and serious adverse events
Time frame: Through study completion, an average of 5 days
Sequelae of PPHN
Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc
Time frame: Through study completion and a 6-month visit
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)
Time frame: Through study completion, an average of 5 days
Pulse oxygen saturation
Pulse oxygen saturation（%）
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Time frame: The first 72 hours of the initial treatment