Brief Title
Safety of Sildenafil in Premature Infants
Official Title
Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia
Brief Summary
Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source - FDA OOPD.
Detailed Description
This will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants. This is a Phase II study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Safety as determined by adverse event experienced by participants
Secondary Outcome
Volume of Distribution
Condition
Bronchopulmonary Dysplasia
Intervention
Sildenafil
Study Arms / Comparison Groups
Sildenafil cohort 1
Description: Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
April 2, 2018
Completion Date
September 30, 2021
Primary Completion Date
September 30, 2021
Eligibility Criteria
Inclusion Criteria: - Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional) - <29 weeks gestational age at birth - 7-28 (inclusive) days postnatal age at time of randomization Exclusion Criteria: - Currently receiving vasopressors - Currently receiving inhaled nitric oxide - Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration - Known allergy to sildenafil - Known sickle cell disease - AST > 225 U/L < 72 hours prior to randomization - ALT > 150 U/L < 72 hours prior to randomization
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Matthew M Laughon, MD, MPH, 984-974-7851, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03142568
Organization ID
17-2436
Secondary IDs
HHSN27500039
Responsible Party
Sponsor
Study Sponsor
University of North Carolina, Chapel Hill
Collaborators
Duke University
Study Sponsor
Matthew M Laughon, MD, MPH, Principal Investigator, University of North Carolina, Chapel Hill
Verification Date
June 2020