Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-24 @ 4:46 AM
Study NCT ID:
NCT02821156
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2016-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Use of Inhaled NO (iNO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iNO characteristics of administration:doses, ventilation mode,concomitant pulmonary vasodilator treatments', 'timeFrame': 'Through iNO administration, an average of 4 days', 'description': 'Data collected by questionnaire'}], 'secondaryOutcomes': [{'measure': 'Profile of patients: age, gender, disease characteristics.', 'timeFrame': '1 day', 'description': 'Data collected by questionnaire'}, {'measure': 'Number and percentage of patients with adverse events', 'timeFrame': 'During iNO administration, an average of 4 days'}, {'measure': 'Number and percentage of patients with adverse drug reaction', 'timeFrame': 'From 1h after the end of iNO administration up to 28 days after ICU discharge', 'description': 'As no adverse drug reaction occured during this study, no specific data on time frame can be implemented'}, {'measure': "Investigator's opinion regarding EZ-KINOX use", 'timeFrame': 'Through iNO administration, an average of 4 days', 'description': 'Data collected by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '1682593', 'type': 'RESULT', 'citation': 'Pepke-Zaba J, Higenbottam TW, Dinh-Xuan AT, Stone D, Wallwork J. Inhaled nitric oxide as a cause of selective pulmonary vasodilatation in pulmonary hypertension. Lancet. 1991 Nov 9;338(8776):1173-4. doi: 10.1016/0140-6736(91)92033-x.'}, {'pmid': '29341967', 'type': 'DERIVED', 'citation': "Gaudard P, Barbanti C, Rozec B, Mauriat P, M'rini M, Cambonie G, Liet JM, Girard C, Leger PL, Assaf Z, Damas P, Loron G, Lecourt L, Amour J, Pouard P. New Modalities for the Administration of Inhaled Nitric Oxide in Intensive Care Units After Cardiac Surgery or for Neonatal Indications: A Prospective Observational Study. Anesth Analg. 2018 Apr;126(4):1234-1240. doi: 10.1213/ANE.0000000000002813."}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, multicenter study conducted during 1 year in adult and paediatric intensive care units equipped with the EZ-KINOX™ system.\n\nA maximum of 250 patients (newborns to adults, suffering from Pulmonary Arterial Hypertension (PAH) associated with cardiac surgery or Persistent Pulmonary Hypertension in the Newborn (PPHN) receiving iNO through the integrated delivery and monitoring EZ-KINOX™ system was planned to be included.\n\nThe study is strictly non-interventional with the aim of describing current practices and therefore did not affect the patient usual management.', 'detailedDescription': 'This study is intended to describe daily practice and therefore, there is not a standardized protocol but only patient-based and site-based questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with PAH associated with heart surgery or PPHN', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn \\> or = to 34 weeks gestational age suffering from hypoxic respiratory failure with pulmonary hypertension (France only) or patient presenting post-operative pulmonary hypertension associated with cardiac surgery (France and Belgium) · Patient treated with iNO delivered with EZ-KINOX™\n\nExclusion Criteria:\n\n* Newborn dependent on a right-to-left shunt or with a "malignant" left-right arterial canal\n* Newborn with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.'}, 'identificationModule': {'nctId': 'NCT02821156', 'acronym': 'POSITIVE', 'briefTitle': 'Study on the Use of Inhaled NO (iNO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Air Liquide Santé International'}, 'officialTitle': 'Prospective Observational Study on the Use of Inhaled NO (iNO) Administered Through an Integrated deliVEry and Monitoring Device EZ-KINOX', 'orgStudyIdInfo': {'id': 'ALMED-13-C4-046'}}, 'armsInterventionsModule': {'interventions': [{'type': 'DRUG', 'otherNames': ['Nitric Oxide'], 'description': 'Inhaled Nitric Oxide with monitoring by EZ-KINOX device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires ST Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Sart TILMAN', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '75651', 'city': 'Paris', 'state': 'Cedex 13', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75743', 'city': 'Paris', 'state': 'Paris Cedex', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Haut-Lévèque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital du Bocage Central', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier - Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôpital Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'American Memorial Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Philippe POUARD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Necker-Enfants Malades'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Liquide Santé International', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}