Neonates and Preterm Infants Clinical Trial
Official title:
Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
Verified date | October 2017 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
Korea, Republic of | Seoul National University Children's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC(0-t) | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics | t up to 5 weeks | |
Primary | Cmax(0-t) | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics | t up to 5 weeks | |
Secondary | Change from baseline in pulmonary arterial hypertension at 5 weeks | 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 |
pre, 2 weeks, 5 weeks of drug administration | |
Secondary | respiratory severity score | Mean airway pressure x FiO2 | pre, 2 weeks, 5 weeks after administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04525495 -
Dopamine in Neonate
|
Phase 2 |