Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT00420693
Status:
COMPLETED
Last Update Posted:
2009-01-15
First Post:
2006-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-14', 'studyFirstSubmitDate': '2006-11-23', 'studyFirstSubmitQcDate': '2007-01-09', 'lastUpdatePostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lasted realization of the gesture defined by delay between the first draining and the end of the bandage', 'timeFrame': '24 months'}]}, 'conditionsModule': {'conditions': ['Pain Measurement', 'Newborn']}, 'referencesModule': {'references': [{'pmid': '20546160', 'type': 'DERIVED', 'citation': 'Michel F, Vialet R, Hassid S, Nicaise C, Garbi A, Thomachot L, DI Marco JN, Lagier P, Martin C. Sevoflurane for central catheter placement in neonatal intensive care: a randomized trial. Paediatr Anaesth. 2010 Aug;20(8):712-9. doi: 10.1111/j.1460-9592.2010.03334.x.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit\n* Patient requiring a mechanical ventilation or CPAP\n* Patient requiring a KTEC\n* Given consent\n\nExclusion Criteria:\n\n* Contraindication to sévoflurane\n* Patient already sedated with morphin and/or hypnotics\n* Patient presenting neurologic troubles\n* Patient enrolled in other study\\*\n* Infant without legacy representant'}, 'identificationModule': {'nctId': 'NCT00420693', 'briefTitle': 'Interest of Using the Sevoflurane in the Prevention of Newborns Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Interest of Using the Sevoflurane in the Prevention of Newborns Pain', 'orgStudyIdInfo': {'id': '2006/15'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sevoflurane', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13008', 'city': 'Marseille', 'state': 'BdR', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille CHU Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'fabrice michel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Fabrice MICHEL', 'oldOrganization': 'Assistance Publique Hopitaux De Marseille'}}}}