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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 Ospedale L. Sacco – Polo Universitario.
Recruitment status was:  Recruiting
Information provided by:
Ospedale L. Sacco – Polo Universitario Identifier:
First received: June 7, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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
Skin Diseases, Bacterial
Behavioral: Hygiene
Procedure: Usual alcohol care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Ospedale L. Sacco – Polo Universitario:

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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01369251

Contact: Cristina Meroni

Ospedale Luigi Sacco Recruiting
Milan, Italy, 20157
Contact: Ludovica Tagliabue   
Sponsors and Collaborators
Ospedale L. Sacco – Polo Universitario
Study Director: Cristina Meroni Ospedale L. Sacco – Polo Universitario
Study Chair: Maria Teresa Garavaglia Ospedale L. Sacco – Polo Universitario
Principal Investigator: Ludovica Tagliabue, MD Università di Milano
  More Information Identifier: NCT01369251     History of Changes
Other Study ID Numbers: HSaccoCordCare
Study First Received: June 7, 2011
Last Updated: June 7, 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 processed this record on April 28, 2017