Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 1:44 PM
Study NCT ID:
NCT01383850
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2011-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'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': 'C038949', 'term': 'heliox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in reducing need of MV', 'timeFrame': '7 days', 'description': 'efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life'}], 'secondaryOutcomes': [{'measure': 'surfactant need', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'number of doses of exogenous surfactant'}, {'measure': 'major complications of prematurity', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'incidence of major complications of prematurity'}, {'measure': 'ventilatory assistance', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'number of days of ventilatory assistance'}, {'measure': 'length of stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 weeks', 'description': 'number of days of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preterm infants', 'nasal continuous positive airway pressure', 'heliox', 'bronchopulmonary dysplasia.'], 'conditions': ['Respiratory Distress Syndrome', 'Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '22291116', 'type': 'DERIVED', 'citation': 'Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.'}]}, 'descriptionModule': {'briefSummary': "Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* inborn infants between 28 and 32 weeks of GA\n* Silverman score \\> 5,\n* radiological finding of RDS\n* a requirement of inspiratory flow of oxygen (FiO2) \\> 0,25 (SaO2 ) between 88-95% within the first hour of life.\n\nExclusion Criteria:\n\n* major congenital malformations\n* intraventricular hemorrhage (IVH) more than grade 2\n* need of intubation in the delivery room or requirement of FiO2 \\>0,4 during the first hour of life.'}, 'identificationModule': {'nctId': 'NCT01383850', 'briefTitle': 'NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'orgStudyIdInfo': {'id': 'Heliox'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NCPAP + standard air', 'interventionNames': ['Other: NCPAP + standard air', 'Other: NCPAP + Heliox']}, {'type': 'EXPERIMENTAL', 'label': 'NCPAP + Heliox', 'interventionNames': ['Other: NCPAP + standard air', 'Other: NCPAP + Heliox']}], 'interventions': [{'name': 'NCPAP + standard air', 'type': 'OTHER', 'description': 'NCAP (SiPAP, Vyasis) was used to administer standard air', 'armGroupLabels': ['NCPAP + Heliox', 'NCPAP + standard air']}, {'name': 'NCPAP + Heliox', 'type': 'OTHER', 'description': 'Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.', 'armGroupLabels': ['NCPAP + Heliox', 'NCPAP + standard air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Fabio Mosca', 'oldOrganization': 'Fondazione Ospedale Maggiore Policlinico Milano'}}}}