Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

NCT ID: NCT01369251

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection Skin Diseases, Bacterial Granuloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hygiene with water and soap

Group Type EXPERIMENTAL

Hygiene

Intervention Type BEHAVIORAL

Usual alcohol care

Group Type ACTIVE_COMPARATOR

Usual alcohol care

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hygiene

Intervention Type BEHAVIORAL

Usual alcohol care

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Appropriate for gestational age newborn

Exclusion Criteria

* Not appropriate for gestational age newborn
Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristina Meroni

Role: STUDY_DIRECTOR

ASST Fatebenefratelli Sacco

Maria Teresa Garavaglia

Role: STUDY_CHAIR

ASST Fatebenefratelli Sacco

Ludovica Tagliabue, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Milano

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Luigi Sacco

Milan, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina Meroni

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ludovica Tagliabue

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSaccoCordCare

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immediate VS Delayed Cord Clamping on Newborns
NCT01029496 UNKNOWN PHASE1/PHASE2