Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 4:24 PM
Study NCT ID:
NCT04775459
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'administration time frame (min of life)', 'timeFrame': 'day 1', 'description': 'Time from birth to surfactant administration'}], 'secondaryOutcomes': [{'measure': 'FiO2 maximum', 'timeFrame': 'Week 1', 'description': 'Collect in medical record.: the maximal value of FiO2 from birth to one week of life'}, {'measure': 'delay from FiO2 maximum to FiO2 < 21%', 'timeFrame': 'Week 4', 'description': 'Collect in medical record'}, {'measure': 'Ventilation time (day)', 'timeFrame': 'Week 4', 'description': 'Collect in medical record : number of day using a ventilation'}, {'measure': 'Ventilation support', 'timeFrame': 'Week 4', 'description': 'Collect in medical record : using a invasive ou a non invasive ventilation'}, {'measure': 'Bronchodysplasia rate', 'timeFrame': 'Week 4', 'description': 'Collect in medical record.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm', 'Lung Ultrasound Score', 'Surfactant'], 'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).\n\nThis surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.\n\nStudies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).', 'detailedDescription': 'This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms \\<33 weeks on the time to surfactant administration.\n\nThe current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life.\n\nThis is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'preterm newborns \\< 33 weeks with Respiratory Distress Syndrom needed surfactant administration\n\nDate of birth from 01/08/19 to 31/12/19 and from 01/01/21 to 30/06/21', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborns \\<33 weeks old\n* born at the Saint Etienne University Hospital\n* respiratory distress syndrome\n\nExclusion Criteria:\n\n* chromosomal abnormality,\n* multi-polymalformations syndrome,\n* congenital pulmonary disease,\n* septic shock,\n* congenital lung infection,\n* meconium inhalation,\n* pneumothorax\n* conditions requiring surgery in the first week of life.'}, 'identificationModule': {'nctId': 'NCT04775459', 'acronym': 'ECHOSURF', 'briefTitle': 'Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.', 'orgStudyIdInfo': {'id': 'IRBN232021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surfactant administration without using score LUS', 'description': 'It is a retrospective cohort : preterm newborns from august 2019 to december 2019 needed a surfactant administration.\n\nThe surfactant was administrated only if the fraction of inspired oxygen (FiO2) \\>30% among the Guidelines of 2019', 'interventionNames': ['Drug: Surfactant administration until 2020']}, {'label': 'Surfactant administration using score LUS', 'description': 'It is a prospective cohort : preterm newborns from january 2021 to juin 2020 needed a surfactant administration.\n\nThe surfactant is administrated if FiO2 \\>30% OR if score LUS \\>8/18 among the literature', 'interventionNames': ['Drug: Surfactant administration since 2021']}], 'interventions': [{'name': 'Surfactant administration until 2020', 'type': 'DRUG', 'otherNames': ['No LUS'], 'description': 'Surfactant is administrated if Fi02 \\>30% among the Guidelines of 2019', 'armGroupLabels': ['Surfactant administration without using score LUS']}, {'name': 'Surfactant administration since 2021', 'type': 'DRUG', 'otherNames': ['With LUS'], 'description': 'Surfactant is administrated if Fi02 \\>30% OR if score LUS \\>8/18 among the literature', 'armGroupLabels': ['Surfactant administration using score LUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Aurelie CANTAIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}