Safety of Sildenafil in Premature Infants

Related Clinical Trial
The Budesonide in Babies (BiB) Trial Follow-up Results of Newborns With Tracheostomy Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia Prolonged Outcomes After Nitric Oxide (PrONOx) A Study of Tobacco Smoke and Children With Respiratory Illnesses Delivery Room CPAP in Extremely Low Birth Weight Infants Dexamethasone Therapy in VLBW Infants at Risk of CLD Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children Seattle-PAP Bubble Nasal CPAP and Work of Breathing High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC High Frequency Ventilation in Premature Infants (HIFI) Early Caffeine in Preterm Neonates High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance. Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants Non-invasive Respiratory Support in Preterm Infants Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS Work of Breathing During Non-invasive Ventilation in Premature Neonates Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Intratracheal Budesonide/Surfactant Prevents BPD Bronchopulmonary Disease (BPD) Patient Registry Premature Birth and Its Sequelae in Women Inhaled NO in Prevention of Chronic Lung Disease The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants – Effect on Respiratory Morbidity Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room Growth of Airways and Lung Tissues in Premature and Healthy Infants Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants Assessment of Lung Structure and Function of Infants Born Prematurely Post-hospitalization Nursing Effectiveness (PHONE) Study Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS) Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes Inhaled Beclomethasone to Prevent Chronic Lung Disease Work of Breathing in Premature Infants at Discharge Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome Hydrocortisone for BPD Clinic Features and Outcome of BPD (SGBPD) Neolifes Heart – Pulmonary Hypertension in Preterm Children Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia Management of Hyponatremia in Preterm Infants on Diuretics Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial Respiratory Outcome at Adolescence of Very Low Birthweight Infants Surfactant Administration During Spontaneous Breathing Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease Developmental Sequelae of Severe Chronic Lung Disorders Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator Improving Prematurity-Related Respiratory Outcomes at Vanderbilt Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease – The AD-ON Study Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns Azithromycin in the Prevention of Lung Injury in Premature Newborn Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation MRI in BPD Subjects A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease Early Versus Late Caffeine for ELBW Newborns Assessment of Lung Aeration at Birth MRI of Lung Structure and Function in Preterm Children BPD Saturation TARgeting Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD Antecedents of Bronchopulmonary Dysplasia Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood Aerosolized Albuterol Use in Severe BPD Late Sequelae of Bronchopulmonary Dysplasia Montelukast in Very Low Birthweight Infants Preterm Infant Inhaled Albuterol Dosing 129Xe MRI in Pediatric Population With BPD Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes Comparison of Classification Standards of BPD in Premature Infants Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia Safety of Sildenafil in Premature Infants Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia Trial II of Lung Protection With Azithromycin in the Preterm Infant Forced Oscillometry in Infants With Bronchopulmonary Dysplasia The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia Fluid Filled Lung Oxygenation Assistance Trial Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project) Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants. Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia Physiologic Definition of Bronchopulmonary Dysplasia Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) – a US Study Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD) Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants p16Ink4a in Bronchopulmonary Dysplasia in Children Transpyloric Feeding in Severe Bronchopulmonary Dysplasia Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates Stem Cells for Bronchopulmonary Dysplasia Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD) Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

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