Neonates and Preterm Infants
Conditions
Brief summary
The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.
Interventions
DRUGSildenafil
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital * Infants who were diagnosed with PAH
Exclusion criteria
* Severe allergic reaction to sildenafil * Inotropics for hypotension within 3 days prior to enrollment * AST or ALT \> 3x ULN * Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-t) | t up to 5 weeks | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics |
| Cmax(0-t) | t up to 5 weeks | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pulmonary arterial hypertension at 5 weeks | pre, 2 weeks, 5 weeks of drug administration | Echocardiography * RV systolic pressure: TR velocity2 x 4 * Septum contour: normal, flat at end-systole, flat at end-diastole * LV shape: normal, partially D-shape, D-shape, squeezed * LV eccentricity index * RV area/LV area (Apical 4 chamber view, at end diastole) * RA enlargement (Apical 4 chamber view) * RV anterior wall thickness * TAPSE (Tricuspid annular plane systolic excursion) * RV Tei index (by tissue Doppler) * Tissue Doppler velocity at RV free wall |
| respiratory severity score | pre, 2 weeks, 5 weeks after administration | Mean airway pressure x FiO2 |
Countries
South Korea
Outcome results
None listed