Back to resultsSimple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
Primary Purpose
Infection, Skin Diseases, Bacterial, Granuloma
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Hygiene
Usual alcohol care
Sponsored by
About this trial
This is an interventional prevention trial for Infection
Eligibility Criteria
Inclusion Criteria:
- Appropriate for gestational age newborn
Exclusion Criteria:
- Not appropriate for gestational age newborn
Sites / Locations
- Ospedale Luigi SaccoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hygiene with water and soap
Usual alcohol care
Arm Description
Outcomes
Primary Outcome Measures
omphalitis incidence
Secondary Outcome Measures
umbilical granuloma incidence
time to cord separation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01369251
Brief Title
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
Official Title
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
ASST Fatebenefratelli Sacco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Skin Diseases, Bacterial, Granuloma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hygiene with water and soap
Arm Type
Experimental
Arm Title
Usual alcohol care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Hygiene
Intervention Type
Procedure
Intervention Name(s)
Usual alcohol care
Primary Outcome Measure Information:
Title
omphalitis incidence
Secondary Outcome Measure Information:
Title
umbilical granuloma incidence
Title
time to cord separation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Appropriate for gestational age newborn
Exclusion Criteria:
Not appropriate for gestational age newborn
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Meroni
Email
meroni.cristina@hsacco.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Meroni
Organizational Affiliation
ASST Fatebenefratelli Sacco
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Teresa Garavaglia
Organizational Affiliation
ASST Fatebenefratelli Sacco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ludovica Tagliabue, MD
Organizational Affiliation
Università di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovica Tagliabue
Email
tagliabue.ludovica@hsacco.it
12. IPD Sharing Statement
Learn more about this trial
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
We'll reach out to this number within 24 hrs