Safety of Sildenafil in Premature Infants

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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