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PK Study of Sildenafil in Neonate

Primary Purpose

Neonates and Preterm Infants

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonates and Preterm Infants

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

sildenafil treatment

Outcomes

Primary Outcome Measures

AUC(0-t)
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Cmax(0-t)
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics

Secondary Outcome Measures

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
respiratory severity score
Mean airway pressure x FiO2

Full Information

First Posted
September 11, 2014
Last Updated
October 13, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02244528
Brief Title
PK Study of Sildenafil in Neonate
Official Title
Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonates and Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
sildenafil treatment
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Primary Outcome Measure Information:
Title
AUC(0-t)
Description
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Time Frame
t up to 5 weeks
Title
Cmax(0-t)
Description
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Time Frame
t up to 5 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in pulmonary arterial hypertension at 5 weeks
Description
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
Time Frame
pre, 2 weeks, 5 weeks of drug administration
Title
respiratory severity score
Description
Mean airway pressure x FiO2
Time Frame
pre, 2 weeks, 5 weeks after administration

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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PK Study of Sildenafil in Neonate

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