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Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

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ClinicalTrials.gov Identifier: NCT01369251
Recruitment Status : Unknown
Verified April 2011 by ASST Fatebenefratelli Sacco.
Recruitment status was:  Recruiting
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
Information provided by:
ASST Fatebenefratelli Sacco

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Hygiene with water and soap Behavioral: Hygiene
Active Comparator: Usual alcohol care Procedure: Usual alcohol care

Primary Outcome Measures :
  1. omphalitis incidence

Secondary Outcome Measures :
  1. umbilical granuloma incidence
  2. time to cord separation

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

Inclusion Criteria:

  • Appropriate for gestational age newborn

Exclusion Criteria:

  • Not appropriate for gestational age newborn

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

Contact: Cristina Meroni meroni.cristina@hsacco.it

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

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

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