Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03411018
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2018-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], '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': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BRONCHOPULMONARY DySPLASIA', 'timeFrame': '36 weeks of postmenstrual age.', 'description': 'Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)'}, {'measure': 'mortality', 'timeFrame': 'before discharge', 'description': 'death'}], 'secondaryOutcomes': [{'measure': 'Mechanical ventilation', 'timeFrame': 'during hospitalization', 'description': 'requirement of mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung protective strategies', 'Less invasive respiratory support', 'preterm infant'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.', 'detailedDescription': 'Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.\n\nIn our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.\n\nHypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All preterm infant born with less than 32wGA since January 2012 to December 2017 admitted in our NICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll preterm Infants born with less than 32wGA admitted in our NICU.\n\nExclusion Criteria:\n\nCongenital malformations and Known Chromosomal disorders,'}, 'identificationModule': {'nctId': 'NCT03411018', 'briefTitle': 'Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome', 'orgStudyIdInfo': {'id': 'CEIC 84/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional respiratory managed group.', 'description': 'Preterm infants born with less than 32 weeks gestational age (wGA) that entered in the neonatal Intensive care unit (NICU) from January 1 2012 to December 31 2013. These preterm infants were managed according to prior ventilatory protocol: Prophylactic Continuous positive airway pressure (CPAP) in delivery room, early surfactant administration by INSURE technique and volume target mechanical ventilation with rescue high frequency ventilation when needed. Mechanical ventilation exposure will be analyzed', 'interventionNames': ['Other: Mechanical ventilation exposure']}, {'label': 'Less invasive managed group', 'description': 'Preterm Infants born with less than 32wGA that entered the NICU from January 1 2014 to December 31 2017. This infants are managed according to the actual ventilatory protocol. Prophylactic CPAP in delivery room, early surfactant administration by less invasive technique, nasal Synchronized positive pressure ventilation for CPAP failure and early rescue high frequency ventilation with minimally target volume.Mechanical ventilation exposure will be analyzed', 'interventionNames': ['Other: Mechanical ventilation exposure']}], 'interventions': [{'name': 'Mechanical ventilation exposure', 'type': 'OTHER', 'armGroupLabels': ['Conventional respiratory managed group.', 'Less invasive managed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Cristina Ramos-Navarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Cristina Ramos-Navarro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gregorio Marañon, Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manuel Sanchez Luna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Neonatology, Clinical Professor', 'investigatorFullName': 'Manuel Sanchez Luna', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}