Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT01369251
Status:
UNKNOWN
Last Update Posted:
2011-06-08
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D006099', 'term': 'Granuloma'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006920', 'term': 'Hygiene'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'omphalitis incidence'}], 'secondaryOutcomes': [{'measure': 'umbilical granuloma incidence'}, {'measure': 'time to cord separation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection', 'Skin Diseases, Bacterial', 'Granuloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Appropriate for gestational age newborn\n\nExclusion Criteria:\n\n* Not appropriate for gestational age newborn'}, 'identificationModule': {'nctId': 'NCT01369251', 'briefTitle': 'Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord', 'organization': {'class': 'OTHER', 'fullName': 'ASST Fatebenefratelli Sacco'}, 'officialTitle': 'Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HSaccoCordCare'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hygiene with water and soap', 'interventionNames': ['Behavioral: Hygiene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual alcohol care', 'interventionNames': ['Procedure: Usual alcohol care']}], 'interventions': [{'name': 'Hygiene', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Hygiene with water and soap']}, {'name': 'Usual alcohol care', 'type': 'PROCEDURE', 'armGroupLabels': ['Usual alcohol care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ludovica Tagliabue', 'role': 'CONTACT', 'email': 'tagliabue.ludovica@hsacco.it'}], 'facility': 'Ospedale Luigi Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Cristina Meroni', 'role': 'CONTACT', 'email': 'meroni.cristina@hsacco.it'}], 'overallOfficials': [{'name': 'Cristina Meroni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASST Fatebenefratelli Sacco'}, {'name': 'Maria Teresa Garavaglia', 'role': 'STUDY_CHAIR', 'affiliation': 'ASST Fatebenefratelli Sacco'}, {'name': 'Ludovica Tagliabue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università di Milano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Fatebenefratelli Sacco', 'class': 'OTHER'}}}}