PK Study of Sildenafil in Neonate

Phase 2

Completed

• Conditions: Neonates and Preterm Infants
• Interventions: Drug: Sildenafil

• Registration Number: NCT02244528
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Sildenafil	sildenafil treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of