Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT04214795
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 710}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2019-12-14', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'at hospital discharge, an average of 2-4 months.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.', 'timeFrame': '36 weeks postmenstrual age', 'description': 'BPD is considered as type 2 and 3 by consensus definition'}, {'measure': 'Number of participants requiring Surfactant administration', 'timeFrame': 'in the first 3 days after birth'}, {'measure': 'Number of participants that requires Mechanical ventilation.', 'timeFrame': 'during hospitalization, and average of 2-4 months'}, {'measure': 'Number of participants with Neurodevelopment disability', 'timeFrame': 'performed at 24 months', 'description': 'Scale of Psychomotor Development of Children (the Brunet-Lézine Scale). This scale consists of 150 items that are grouped around the following four areas: Posture (postural control or general motor skills), Coordination (psychomotor coordination), Language (comprehension and expression) and Sociability (social relations). The score of the items is binary (1/0) depending on whether the acquisition evaluated is achieved or not. The development age (ED) is obtained from the sum of the items. The result of dividing the age of development by postmenstrual age is the development quotient (CD). This calculation is practiced both for the set of items on the scale (global development quotient) and for each of the areas (partial development quotients).\n\nWe have considered the value of the overall development quotient of less than 85 as the limit of normality, since it is a standard deviation below the expected development for its age.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbidity;Newborn']}, 'descriptionModule': {'briefSummary': 'The aim is to evaluate the impact of a complete course of antenatal steroids treatment on mortality and main morbidities in a current population of preterm infants.', 'detailedDescription': 'All infants admitted in the Neonatal Department born with less than 32 weeks of gestational age are included.\n\nData are prospectively recorded. Perinatal variables (Gestational age, materna condition at admission, antenatal steroids treatment, gender and results of histological analysis of the placenta) are recorded as well as respiratory status during hospitalization and morbidities at discharge. Results of neurodevelopment test performed at 24 months of corrected age are also included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants admitted with less than 6 hours after birth in the Gregorio Marañón Neonatal Department born with less than 32 weeks GA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).\n\nExclusion Criteria:\n\n* Congenital malformations.\n* premature infants in whom active resuscitation measures are not established.'}, 'identificationModule': {'nctId': 'NCT04214795', 'briefTitle': 'Antenatal Steroids Effect on Mortality and Respiratory Outcomes in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants', 'orgStudyIdInfo': {'id': 'ANS- 2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants born after a complete course of antenatal steroids.', 'description': 'Preterm Infants born with less than 32 w GA whose mothers had received a complete course (two doses of celestone in the period between 24 hours and 7 days before delivery.', 'interventionNames': ['Other: Observational study. Postnatal variables are recorded']}, {'label': 'Infants born without a complete course of antenatal steroids', 'description': 'Preterm Infants born with less than 32 w GA whose mothers did not received any dose of celestone or an uncompleted course (less than 24 hours or more than 7 days from delivery).', 'interventionNames': ['Other: Observational study. Postnatal variables are recorded']}], 'interventions': [{'name': 'Observational study. Postnatal variables are recorded', 'type': 'OTHER', 'description': 'Postnatal evolution is analyzed in both groups', 'armGroupLabels': ['Infants born after a complete course of antenatal steroids.', 'Infants born without a complete course of antenatal steroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28033', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Cristina Ramos-Navarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Manuel Sánchez-Luna, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gregorio Marañón Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor. Pediatric Profesor', 'investigatorFullName': 'Manuel Sanchez Luna', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}