Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

Phase 3

• Conditions: Infection; Skin Diseases, Bacterial; Granuloma
• Interventions: Behavioral: Hygiene; Procedure: Usual alcohol care

• Registration Number: NCT01369251
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-05
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Last Update Submitted: 2011-06-07
• Study First Posted: 2011-06-08
• Last Update Posted: 2011-06-08
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Appropriate for gestational age newborn

Exclusion Criteria

• Not appropriate for gestational age newborn

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hygiene with water and soap	Hygiene	-
Usual alcohol care	Usual alcohol care	-

Primary Outcome Measures

Name	Time	Method
omphalitis incidence

Secondary Outcome Measures

Name	Time	Method
umbilical granuloma incidence
time to cord separation

Trial Locations

Locations (1)

Ospedale Luigi Sacco; 🇮🇹 Milan, Italy