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Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Ospedale L. Sacco – Polo Universitario.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ospedale L. Sacco – Polo Universitario
ClinicalTrials.gov Identifier:
NCT01369251
First received: June 7, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Appropriate for gestational age newborn

Exclusion Criteria:

  • Not appropriate for gestational age newborn
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Ospedale L. Sacco – Polo Universitario
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT01369251     History of Changes
Other Study ID Numbers: HSaccoCordCare
Study First Received: June 7, 2011
Last Updated: June 7, 2011
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013