NCT01369251

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2011

Enrollment Period

1.6 years

First QC Date

June 7, 2011

Last Update Submit

June 7, 2011

Conditions

InfectionSkin Diseases, BacterialGranuloma

Outcome Measures

Primary Outcomes (1)

  • omphalitis incidence

Secondary Outcomes (2)

  • umbilical granuloma incidence

  • time to cord separation

Study Arms (2)

Hygiene with water and soap

EXPERIMENTAL
Behavioral: Hygiene

Usual alcohol care

ACTIVE COMPARATOR
Procedure: Usual alcohol care

Interventions

HygieneBEHAVIORAL
Hygiene with water and soap
Usual alcohol carePROCEDURE
Usual alcohol care

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Appropriate for gestational age newborn

You may not qualify if:

  • Not appropriate for gestational age newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Luigi Sacco

Milan, 20157, Italy

RECRUITING

MeSH Terms

Conditions

InfectionsSkin Diseases, BacterialGranuloma

Interventions

HygieneEthanol

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPublic HealthEnvironment and Public HealthAlcoholsOrganic Chemicals

Study Officials

  • Cristina Meroni

    ASST Fatebenefratelli Sacco

    STUDY DIRECTOR

  • Maria Teresa Garavaglia

    ASST Fatebenefratelli Sacco

    STUDY CHAIR

  • Ludovica Tagliabue, MD

    Università di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Meroni

CONTACT

meroni.cristina@hsacco.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 8, 2011

Record last verified: 2011-04

Locations

IT(1)