Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

ASST Fatebenefratelli Sacco

Status and phase: Unknown; Phase 3

Conditions: Infection; Skin Diseases, Bacterial; Granuloma

Treatments: Procedure: Usual alcohol care; Behavioral: Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT01369251

HSaccoCordCare

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Appropriate for gestational age newborn

Exclusion criteria

• Not appropriate for gestational age newborn

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Hygiene with water and soap

Experimental group

Treatment:

Behavioral: Hygiene

Usual alcohol care

Active Comparator group

Treatment:

Procedure: Usual alcohol care