Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04619602
Status:
WITHDRAWN
Last Update Posted:
2025-08-22
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhaled Treatment for Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'FDA hold', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Emergent Adverse Events', 'timeFrame': '7 days', 'description': 'Occurrence of \\>grade 3 adverse events related to the treatment'}], 'secondaryOutcomes': [{'measure': 'S-nitrosoglutathione change', 'timeFrame': '30 minutes', 'description': 'Percent change in S-nitrosoglutathione pre/post treatment'}, {'measure': 'Change in oxygen saturation index', 'timeFrame': '4 hours', 'description': 'Percent change in oxygen saturation index (O.S.I.) pre/post treatment. oxygen saturation index \\[O.S.I. = (FiO2) x (mean airway pressure) x 100 / (SpO2)\\]. High OSI scores indicate worse respiratory failure (high OSI = bad, low OSI = good).Scale range: zero - infinity'}, {'measure': 'Change in GSNO catabolism pre/post treatment', 'timeFrame': '30 minutes', 'description': 'Percent change in GSNO catabolism pre/post treatment'}, {'measure': 'Intermittent hypoxemia as measured by oxygen saturation post treatment', 'timeFrame': '4 hours', 'description': 'Incidence, duration, and nadirs of intermittent hypoxemia (SpO2 \\<80%) as measured by oxygen saturation parameters post treatment'}, {'measure': 'Ventilator parameters post treatment', 'timeFrame': '4 hours', 'description': 'Change in ventilator parameters post treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchopulmonary dysplasia', 'respiratory failure'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia', 'detailedDescription': 'Open label study with 20 participants, open-label, with block dose escalation of 3 subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM). A minimum of seven days of surveillance will separate dosing blocks. An additional 11 subjects will be enrolled at the maximum 1 mM block (5x10-7 moles/kg). The primary outcomes are safety during 30 minutes of inhalation, and for 4 hours after inhalation, as measured by occurrence of adverse events related to the treatment + time period \\[during administration and tracked for next 7 days\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '365 Days', 'minimumAge': '29 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inborn or outborn infants of either sex or any race or ethnicity\n2. \\<32 weeks gestation at birth (best obstetrical dating)\n3. Aged 29 to 365 days\n4. Refractory hypoxic respiratory failure (average daily FiO2 \\>35% for 5 days)\n5. Requires mechanical ventilation via endotracheal airway\n\nExclusion Criteria:\n\n1. Life-threatening congenital or acquired anomalies (lethal chromosomal, thoracic/cardiac, brain)\n2. Unstable condition defined as severe hypoxemia (FiO2 \\>85% for \\>24hrs), sepsis, or hypotension\n3. Baseline methemoglobin \\> 3%, congenital methemoglobinemia, or a familial hemoglobinopathy\n4. On steroid to facilitate endotracheal extubation\n5. Individuals on inhaled nitric oxide, a phosphodiesterase 5 (PDE-5) inhibitor, taking allopurinol, β-adrenergic blockers, tricyclic antidepressants, meperidine (or related CNS agents), or nitrates\n6. Thrombocytopenia defined as \\<50,000 platelets/µL on weekly NICU labs, clinical evidence of bleeding, on an anti-coagulant, or individuals with an inherited or acquired coagulation disorder\n7. Anemia defined as a hemoglobin of \\< 9 mg/dL on weekly NICU labs\n8. Concerns for pre-existing liver damage defined as an AST/ALT \\> 50 IU/L or direct bilirubin \\>1 mg/dL on weekly NICU labs\n9. Concerns for acute kidney injury defined as a serum creatinine \\> 0.7 mg/dL on weekly NICU labs or 24-hr urine output \\<1.0 ml/kg/hr during preceding 4 days\n10. Patients that are ventilated with a device not certified for blending of aerosolized solutions into the ventilator circuit\n11. Physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely\n12. Subjects that have experienced cardiac arrest with CPR for longer than 30 minutes'}, 'identificationModule': {'nctId': 'NCT04619602', 'briefTitle': 'Inhaled Treatment for Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Pilot Study of an Inhaled Treatment for Bronchopulmonary Dysplasia', 'orgStudyIdInfo': {'id': 'BPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSNO therapy', 'description': 'Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.', 'interventionNames': ['Drug: GSNO']}], 'interventions': [{'name': 'GSNO', 'type': 'DRUG', 'description': 'Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.', 'armGroupLabels': ['GSNO therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "University Hospitals Cleveland Medical Center Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Thomas Raffay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Thomas Michael Raffay, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}