Persistent Pulmonary Hypertension of the Newborn
Conditions
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 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.
Interventions
Sponsors
West China Second University Hospital
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation index | The first 72 hours of the initial treatment | Oxygenation index=(fraction of inspired oxygen\*mean airway pressure)/the partial pressure of arterial oxygen |
| The change of hemodynamics | Through study completion, an average of 5 days | * Pulmonary artery pressure (mmHg) * Alveolar-arterial gradient (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion, an average of 5 days | Drug-related adverse events and serious adverse events |
| Sequelae of PPHN | Through study completion and a 6-month visit | Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc |
| Duration of hospitalization | Within the first 28 days of patients' life | Duration of initial therapy |
| Pulse oxygen saturation | The first 72 hours of the initial treatment | Pulse oxygen saturation（%） |
| The need of extra support | Through study completion, an average of 5 days | Besides the initial therapy (bosentan, sildenafil and/or tadalafil), other support such as inhaled nitric oxide (iNO), inotropic agents or Extracorporeal Membrane Oxygenation (ECMO) |
| Death | Within the first 28 days of patients' life | Death in the first 28 days of life |
Countries
China
Outcome results
None listed