Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT05737095
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria', 'timeFrame': 'Within 6 hours of admission', 'description': 'Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Respiratory Distress', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital.\n\nThe objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress.\n\nPulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed.\n\nContinued management according to protocols without taking into account the ultrasound data.\n\nFollow-up of patients until discharge from hospital or D28 of life (whichever comes first)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'minimumAge': '0 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verbal consent from at least one legal guardian\n* Premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life\n* Hospitalized at the Dijon University Hospital in the Neonatal Pediatrics and Intensive Care Units\n\nExclusion Criteria:\n\n* individual is not affiliated to the national health care system\n* major intrathoracic or abdominal malformation'}, 'identificationModule': {'nctId': 'NCT05737095', 'acronym': 'REchoPP', 'briefTitle': 'Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital', 'orgStudyIdInfo': {'id': 'TERNOY-LANZINI 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premature infants', 'description': 'premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress', 'interventionNames': ['Procedure: Pulmonary ultrasound']}], 'interventions': [{'name': 'Pulmonary ultrasound', 'type': 'PROCEDURE', 'description': 'Within 6 hours of admission to Neonatal Pediatrics and Intensive Care', 'armGroupLabels': ['Premature infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}