Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-22 @ 11:03 AM
Study NCT ID:
NCT02760966
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2016-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D012915', 'term': 'Soaps'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003902', 'term': 'Detergents'}, {'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of cord separation', 'timeFrame': '15 days', 'description': 'Examine the differences in the cord separation time between alcohol 70º and soap.'}], 'secondaryOutcomes': [{'measure': 'Umbilical cord infection', 'timeFrame': '28 days'}, {'measure': 'Omphalitis', 'timeFrame': '28 days'}, {'measure': 'Pneumonia', 'timeFrame': '28 days'}, {'measure': 'Diarrhea', 'timeFrame': '28 days'}, {'measure': 'Tetanus', 'timeFrame': '28 days'}, {'measure': 'Neonatal mortality', 'timeFrame': '60 days'}, {'measure': 'Hospital admissions', 'timeFrame': '60 days'}, {'measure': 'Emergency department admissions', 'timeFrame': '60 days'}, {'measure': 'Unscheduled consultations', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Umbilical Cord']}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn.', 'detailedDescription': 'Randomized clinical trial, which objective is to assess the effectiveness of 70º alcohol compared with neutral soap on the cord separation time of a selection of newborns. 34 newborns admitted to the maternity ward of the hospital have participated. The study is divided into two phases, hospital and home. The first stage is located in the hospital, where the patients who will become part of the study are chosen. After receiving the informed letting of the legal guardian the second part of this phase is started; which aim is to explain the steps to be followed to make a correct cleaning cord technique. The home phase consists of being in contact with the family through Whatsapp on the 5th day from birth, the day of the cord fall and 5 days after this fall. Making some simple questions with simple answers such as yes or no and with the possibility, or not, of sending a picture of the cord state in each follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Days', 'minimumAge': '6 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Availability of legal guardians with knowledge and access to Whatsapp.\n\nExclusion Criteria:\n\n* Admission in the newborn's room.\n* Patients with strong concomitant illness, that limits the planned activities or whose current state contraindicates the incorporation of the program.\n* Mother's age \\< 18 years old.\n* Bad controlled mother's diabetes (at least two digits of blood glucose \\<180 mg/dl per day), bad alimentation control and/or non-adherence."}, 'identificationModule': {'nctId': 'NCT02760966', 'briefTitle': 'Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Effectiveness of Alcohol 70º Compared With Soap on Cord Separation Time and the Complication Rate in the Newborn', 'orgStudyIdInfo': {'id': 'IIBSP-ALC-2015-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol 70º', 'description': 'Umbilical cord care will be carried out using alcohol 70º at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.', 'interventionNames': ['Other: Alcohol 70º']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soap', 'description': 'Umbilical cord care will be carried out using soap at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.', 'interventionNames': ['Other: Soap']}], 'interventions': [{'name': 'Alcohol 70º', 'type': 'OTHER', 'armGroupLabels': ['Alcohol 70º']}, {'name': 'Soap', 'type': 'OTHER', 'otherNames': ['Jabón neutro'], 'armGroupLabels': ['Soap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08026', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lara Perez', 'role': 'CONTACT', 'email': 'lperezrou@santpau.cat', 'phone': '+935537508'}, {'name': 'Lara Perez-Rouco', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ana Lopez-Arigüel', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Lara Perez', 'role': 'CONTACT', 'email': 'lperezrou@santpau.cat', 'phone': '+935537508'}], 'overallOfficials': [{'name': 'Lara Perez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}