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NCT01369251 Clinical Trial

Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

Infection Clinical Trial

Official title:
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01369251
Other study ID # HSaccoCordCare
Secondary ID
Status Recruiting
Phase Phase 3
First received June 7, 2011
Last updated June 7, 2011
Start date May 2011
Est. completion date December 2012

Study information
Verified date April 2011
Source Ospedale L. Sacco – Polo Universitario
Contact Cristina Meroni
Email meroni.cristina@hsacco.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Day
Eligibility Inclusion Criteria:

- Appropriate for gestational age newborn

Exclusion Criteria:

- Not appropriate for gestational age newborn

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Hygiene

Procedure:
• Usual alcohol care

Locations
Country Name City State
Italy Ospedale Luigi Sacco Milan

Sponsors (1)
Lead Sponsor Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary omphalitis incidence
Secondary umbilical granuloma incidence
Secondary time to cord separation
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