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Status unknownNCT01369251Updated Jun 8, 2011

Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

A Phase 3 interventional study of Hygiene and Usual alcohol care in Infection, Skin Diseases, Bacterial and Granuloma, sponsored by ASST Fatebenefratelli Sacco. Status unknown at 1 site in Italy. Open to participants aged Up to 1 Day. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by ASST Fatebenefratelli Sacco · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
Up to 1 Day
Sex
All
01

Study 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.

02

Conditions studied

  • Infection
  • Skin Diseases, Bacterial
  • Granuloma
03

In context

Infections

6,702 studies on the registry are indexed under Infections; 801 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 4,205 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

ASST Fatebenefratelli Sacco is the lead sponsor of 38 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Day
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Appropriate for gestational age newborn

Exclusion criteria

Exclusion Criteria:

  • Not appropriate for gestational age newborn
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Hygiene with water and soap

    Behavioral: Hygiene

  • Active comparator
    Usual alcohol care

    Procedure: Usual alcohol care

Interventions

  • BehavioralHygiene
  • ProcedureUsual alcohol care
06

What researchers measure

Primary outcomes

  1. omphalitis incidence

Secondary outcomes

  1. umbilical granuloma incidence

  2. time to cord separation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01369251
Lead sponsor
ASST Fatebenefratelli Sacco
First posted
Jun 8, 2011
Start date
May 2011
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jun 8, 2011

Study contacts

Cristina Meroni
Contact
meroni.cristina@hsacco.it
Cristina Meroni
study director · ASST Fatebenefratelli Sacco
Maria Teresa Garavaglia
study chair · ASST Fatebenefratelli Sacco
Ludovica Tagliabue, MD
principal investigator · Università di Milano

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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