Surveillance Study of Bacterial Contamination of the Pare... | NCT01560936

Studies
Surveillance Study of Bacterial Contamination of the Parent's Cell Phone in the NICU

NCT01560936

Sponsor

Pediatrix

Status

Completed

Last Update Posted

Aug 16, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Bacterial Contamination Rate of the Cell Phones

Interventions

Not provided

Countries

United States

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

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 22, 2012Estimated

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

Aug 14, 2018

Last Update Posted Date

Aug 16, 2018Actual

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 determine the contamination rate of the parents cell phone in a newborn intensive care setting and identify the types of bacteria contaminating the cell phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the transmission of bacteria from the cell phone to the parents hands.

Detailed Description

J Perinatol. 2013 Dec;33(12):960-3. doi: 10.1038/jp.2013.108. Epub 2013 Sep 5.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine contamination rate of parents cellphone in the NICU and identify types of bacteria on cell phones while evaluating the effectiveness of antimicrobial gel in reducing the transmission of bacteria from cellphone to parents hands.		contamination rate through bacterial swabs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents with a cell phone

Exclusion Criteria:

Parents that do not have a cell phone

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Parent's that have a cell phone when visiting their child in the NICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Kamitsuka, MD	Swedish Hospital and Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Medical Center		Seattle	Washington		United States