Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-17 @ 8:30 PM
Study NCT ID:
NCT02893956
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditions of Realization of the Echocardiography in Newborns
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'value of the ratio of the acceleration time of pulmonary arterial flow.', 'timeFrame': 'up to 1 hour', 'description': 'for each echocardiography (support condition and postural support)'}, {'measure': 'value of the ejection time of pulmonary arterial flow', 'timeFrame': 'up to 1 hour', 'description': 'for each echocardiography (support condition and postural support)'}], 'secondaryOutcomes': [{'measure': 'pain assessment with a clinical scale', 'timeFrame': 'up to 1 hour', 'description': 'assessment of the pain with a practical behavioral observation scale'}, {'measure': 'number of participant with a Patent ductus arteriosus shunt', 'timeFrame': 'up to 2 hours'}, {'measure': 'systolic pulmonary arterial pressure', 'timeFrame': 'up to 2 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Echocardiography', 'postural support', 'preterm neonate'], 'conditions': ['Premature Newborn']}, 'descriptionModule': {'briefSummary': 'Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it.\n\nStudy design\n\nProspective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age \\< 48 hours, and requiring invasive mechanical ventilation.\n\nCrossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support.\n\nThe objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow.\n\nThe others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn than 30 weeks of gestation neonates,\n* Newborn with a post natal age \\< 48 hours,\n* Newborn requiring invasive mechanical ventilation.\n* Signed consent form of parent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02893956', 'briefTitle': 'Conditions of Realization of the Echocardiography in Newborns', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?', 'orgStudyIdInfo': {'id': '9252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'echocardiography with postural support then standard condition', 'description': 'the first echocardiography (ultrasound) is performed with a postural support then the second echocardiography is performed with standard condition', 'interventionNames': ['Procedure: echocardiography with postural support', 'Procedure: echocardiography with standard condition (usual)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'echocardiography with standard condition then support postural', 'description': 'the first echocardiography (ultrasounds) is performed with standard condition (usual) and the second echocardiography is performed with a postural support', 'interventionNames': ['Procedure: echocardiography with postural support', 'Procedure: echocardiography with standard condition (usual)']}], 'interventions': [{'name': 'echocardiography with postural support', 'type': 'PROCEDURE', 'armGroupLabels': ['echocardiography with postural support then standard condition', 'echocardiography with standard condition then support postural']}, {'name': 'echocardiography with standard condition (usual)', 'type': 'PROCEDURE', 'armGroupLabels': ['echocardiography with postural support then standard condition', 'echocardiography with standard condition then support postural']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}