Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-02 @ 4:08 AM
Study NCT ID:
NCT03142568
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Sildenafil in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-18'}], 'estimatedResultsFirstSubmitDate': '2025-12-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as determined by adverse event experienced by participants', 'timeFrame': '42 days for each participant', 'description': 'Description of safety of sildenafil in premature infants at risk of BDP. Safety will be assessed following initial study-specific procedure e.g., screening blood draws, dosing through 14 days post last study dose and it will be assessed by frequency and incidence of adverse events and serious adverse events.'}], 'secondaryOutcomes': [{'measure': 'Volume of Distribution', 'timeFrame': 'Samples collected after any dose following completion of 14 days of study drug administration.', 'description': 'Volume of distribution \\[ Time Frame: 8 hr. dosing: time frame: 0-15 min, 30-60 min, 1-2, 2-3, 3-4, 4-5, within 15 min prior to next dose, and 16-24 hrs. after last dose.\\]'}, {'measure': 'Clearance', 'timeFrame': 'Samples collected after any dose following completion of 14 days of study drug administration.', 'description': 'Clearance \\[ Time Frame:8hr dosing: time frame: 0-15 min, 30-60 min, 1-2, 2-3, 3-4, 4-5, within 15 min prior to next dose, and 16-24 hrs. after last dose.\\]'}, {'measure': 'Half-Life', 'timeFrame': 'Samples collected after any dose following completion of 14 days of study drug administration.', 'description': 'Half-life \\[ Time Frame: 8hr. dosing: time frame: 0-15 min, 30-60 min, 1-2, 2-3, 3-4, 4-5, within 15 min prior to next dose, and 16-24 hrs. after last dose.'}, {'measure': 'Area Under the Curve (AUC)', 'timeFrame': 'Samples collected after any dose following completion of 14 days of study drug administration.', 'description': 'Area under the plasma concentration versus time curve (AUC) of sildenafil. \\[Time Frame: 8hr. dosing: time frame: 0-15 min, 30-60 min, 1-2, 2-3, 3-4, 4-5, within 15 min prior to next dose, and 16-24 hrs. after last dose.\\]'}, {'measure': 'Peak Plasma Concentration', 'timeFrame': 'Samples collected after any dose following completion of 14 days of study drug administration.', 'description': 'Maximum concentration Peak Plasma Concentration (Cmax) of sildenafil \\[Time Frame: 8hr. dosing: time frame: 0-15 min, 30-60 min, 1-2, 2-3, 3-4, 4-5, within 15 min prior to next dose, and 16-24 hrs. after last dose.\\]'}, {'measure': 'Change in moderate-severe BPD or death risk from baseline', 'timeFrame': '36 weeks postmenstrual age', 'description': 'Moderate-severe BPD or death risk will be defined by the NICHD Neonatal Research Network BPD outcome estimator. https://neonatal.rti.org/\n\nThe BPD outcome estimator uses the following information to provide individual risk of BPD:\n\n1. Gestational age (weeks)\n2. Birth weight (g)\n3. Sex\n4. Maternal Race/Ethnicity\n5. Postnatal day\n6. Ventilation type (on the postnatal day of interest)\n7. FiO2 (%) (on the postnatal day of interest)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* \\<29 weeks gestational age at birth\n* 7-28 (inclusive) days postnatal age at time of randomization\n\nExclusion Criteria:\n\n* Currently receiving vasopressors\n* Currently receiving inhaled nitric oxide\n* Baseline mean arterial pressure \\< gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration\n* Known allergy to sildenafil\n* Known sickle cell disease\n* AST \\> 225 U/L \\< 72 hours prior to randomization\n* ALT \\> 150 U/L \\< 72 hours prior to randomization'}, 'identificationModule': {'nctId': 'NCT03142568', 'acronym': 'SIL02', 'briefTitle': 'Safety of Sildenafil in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia', 'orgStudyIdInfo': {'id': '17-2436'}, 'secondaryIdInfos': [{'id': '75N94022F00001', 'type': 'OTHER_GRANT', 'domain': 'NICHD'}, {'id': 'R01FD006099-01', 'link': 'https://reporter.nih.gov/quickSearch/R01FD006099-01', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cohort 1', 'description': 'Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sildenafil cohort 2', 'description': 'Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cohort 2', 'description': 'Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sildenafil cohort 3', 'description': 'Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cohort 3', 'description': 'Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Revatio'], 'description': 'Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.', 'armGroupLabels': ['Sildenafil cohort 1', 'Sildenafil cohort 2', 'Sildenafil cohort 3']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['sugar water'], 'description': 'Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).', 'armGroupLabels': ['Placebo cohort 1', 'Placebo cohort 2', 'Placebo cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Jacksonville Shands Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wesley Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40356', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Baptist Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Children's Hospital of Nevada at UMC", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07740', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Monmouth Medical Center', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of NY", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': "Golisano Children's Hospital - University of Rochester Medical Center", 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WakeMed Health and Hospitals', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Centre Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Matthew M Laughon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}