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Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by ASST Fatebenefratelli Sacco.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369251
First Posted: June 8, 2011
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ASST Fatebenefratelli Sacco
  Purpose
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.

Condition Intervention Phase
Infection Skin Diseases, Bacterial Granuloma Behavioral: Hygiene Procedure: Usual alcohol care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial

Further study details as provided by ASST Fatebenefratelli Sacco:

Primary Outcome Measures:
  • omphalitis incidence

Secondary Outcome Measures:
  • umbilical granuloma incidence
  • time to cord separation

Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hygiene with water and soap Behavioral: Hygiene
Active Comparator: Usual alcohol care Procedure: Usual alcohol care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Appropriate for gestational age newborn

Exclusion Criteria:

  • Not appropriate for gestational age newborn
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369251


Contacts
Contact: Cristina Meroni meroni.cristina@hsacco.it

Locations
Italy
Ospedale Luigi Sacco Recruiting
Milan, Italy, 20157
Contact: Ludovica Tagliabue       tagliabue.ludovica@hsacco.it   
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
Investigators
Study Director: Cristina Meroni ASST Fatebenefratelli Sacco
Study Chair: Maria Teresa Garavaglia ASST Fatebenefratelli Sacco
Principal Investigator: Ludovica Tagliabue, MD Università di Milano
  More Information

ClinicalTrials.gov Identifier: NCT01369251     History of Changes
Other Study ID Numbers: HSaccoCordCare
First Submitted: June 7, 2011
First Posted: June 8, 2011
Last Update Posted: June 8, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Skin Diseases
Granuloma
Skin Diseases, Bacterial
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Bacterial Infections
Skin Diseases, Infectious
Infection
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs