Simple Hygiene Versus Alcohol Based Usual Care for Umbili... | NCT01369251

Studies
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord

NCT01369251

Sponsor

ASST Fatebenefratelli Sacco

Status

Unknown status

Last Update Posted

Jun 8, 2011Estimated

Enrollment

400Estimated

Phase

Phase 3

Conditions

Infection
Skin Diseases, Bacterial
Granuloma

Interventions

Hygiene
Usual alcohol care

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 7, 2011

First Posted Date

Jun 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hygiene with water and soap	Experimental		Behavioral: Hygiene
Usual alcohol care	Active Comparator		Procedure: Usual alcohol care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hygiene	Behavioral		Hygiene with water and soap
Usual alcohol care

Measure	Description	Time Frame
omphalitis incidence

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Appropriate for gestational age newborn

Exclusion Criteria:

Not appropriate for gestational age newborn

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Day

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cristina Meroni	Contact			meroni.cristina@hsacco.it

Overall Officials

Name	Affiliation	Role
Cristina Meroni	ASST Fatebenefratelli Sacco	Study Director
Maria Teresa Garavaglia	ASST Fatebenefratelli Sacco	Study Chair
Ludovica Tagliabue, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Luigi Sacco	Recruiting	Milan		20157	Italy

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D017192	Skin Diseases, Bacterial
D006099	Granuloma

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D012874	Skin Diseases, Infectious
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006920	Hygiene
D000431	Ethanol

Ancestor Terms

ID	Term
D013812	Therapeutics
D011634	Public Health
D004778	Environment and Public Health
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided