Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-03 @ 3:06 PM
Study NCT ID:
NCT01024361
Status:
UNKNOWN
Last Update Posted:
2009-12-23
First Post:
2009-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cpap at Delivery Room for Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-02-23', 'releaseDate': '2012-01-23'}, {'resetDate': '2014-12-02', 'releaseDate': '2014-12-02'}], 'estimatedResultsFirstSubmitDate': '2012-01-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2009-11-27', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Necessity of mechanical ventilation and surfactant during the first 5 days of life', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life', 'timeFrame': '15 minutes'}, {'measure': 'Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis', 'timeFrame': '30 days'}, {'measure': 'Oxygen use', 'timeFrame': '28 days'}, {'measure': 'Oxygen use', 'timeFrame': '56 days'}, {'measure': 'Oxygen use', 'timeFrame': '36 weeks of corrected age'}, {'measure': 'Retinopathies of prematurity', 'timeFrame': 'Hospital stay'}, {'measure': 'Death during hospitalization', 'timeFrame': 'Hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preterm infants', 'Nasal CPAP', 'Delivery room', 'Newborn'], 'conditions': ['Mechanical Ventilation', 'Retinal Disease', 'Death', 'Respiratory Tract Disease']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.', 'detailedDescription': 'A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Minutes', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Inborn.\n\n* Birth weight 1000g to 1500g\n* No major malformations\n\nExclusion Criteria:\n\n* Necessity of intubation\n* Maternal decision'}, 'identificationModule': {'nctId': 'NCT01024361', 'acronym': 'CPAP-DR', 'briefTitle': 'Cpap at Delivery Room for Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'CPAP Application at Delivery Room at Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': '120789'}, 'secondaryIdInfos': [{'id': 'FAPESP 06/61388-2', 'type': 'OTHER_GRANT', 'domain': 'FAPESP 06/61388-2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine', 'description': 'Routine protocol of the service'}, {'type': 'EXPERIMENTAL', 'label': 'CPAP-DR', 'description': 'Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'otherNames': ['Neopuff'], 'description': 'CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff', 'armGroupLabels': ['CPAP-DR']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Francisco E Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of sao Paulo at Ribeirão Preto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Francisco Eulogio Martinez/ Professor Titular', 'oldOrganization': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-01-23', 'type': 'RELEASE'}, {'date': '2012-02-23', 'type': 'RESET'}, {'date': '2014-12-02', 'type': 'RELEASE'}, {'date': '2014-12-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Francisco Eulogio Martinez, Francisco Eulogio Martinez/ Professor Titular, University of Sao Paulo, University of Sao Paulo'}}}}