Pneumonia Chart Review Cambodia | NCT03260413

Studies
Pneumonia Chart Review Cambodia

NCT03260413

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Mar 27, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pneumonia

Interventions

Not provided

Countries

Not provided

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Could not get IRB approval

Expanded Access Info

Start Date

Feb 12, 2018Estimated

Primary Completion Date

Mar 9, 2018Estimated

Completion Date

Mar 9, 2018Estimated

First Submitted Date

Aug 21, 2017

First Submission Date that Met QC Criteria

Aug 21, 2017

First Posted Date

Aug 24, 2017Actual

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

Mar 23, 2018

Last Update Posted Date

Mar 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study aims to answer the question of what is the burden of lower respiratory disease (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary objective will be to quantify the prevalence of severe pneumonia at Chenla Children's Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart review of the medical records available at Chenla Children's Healthcare.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumonia cases		Children between the ages of 1 month through 5 years of age who are admitted to Chenla Children's Healthcare between opening of the hospital (mid-2017) and early February 2018 for pneumonia and respiratory distress.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pneumonia count	Number of admissions for pneumonia to Chenla Children's healthcare	5-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children between the ages of 1 month and 5 years admitted to Chenla Children's Healthcare with at least one admitting diagnosis being pneumonia or bronchiolitis will be included.

Exclusion Criteria:

Children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

5 Years

Standard Ages

Child

Study Population

The study population will be children between the ages of 1 month and 5 years who were admitted to Chenla Children's Healthcare with at least one admitting diagnosis being "pneumonia" or "bronchiolitis". These children will be residents of Kratie province, Cambodia. They are admitted to Chenla Children's Healthcare by way of their emergency department.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data from this chart review will be used to inform baseline information of a larger study that is currently in the planning stages. All investigators participating in this chart review are also investigators in this larger study. Information from this chart review will only be accessed by investigators participating in this larger study and by no one outside of this larger study.

Types

Study Protocol
Clinical Study Report (CSR)
Analytic Code

Time Frame

The data will become available by March 10, 2018. It will be available for 4 years.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided