The Nature of Reflux-respiratory Symptoms Association in... | NCT00512382

Studies
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies

NCT00512382

Sponsor

Wolfson Medical Center

Status

Completed

Last Update Posted

Sep 7, 2011Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Asthma
Cough
Wheezing

Interventions

WEEM - Wheezy Monitoring

Countries

Israel

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

Sep 2011

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

Mar 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

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

Sep 4, 2011

Last Update Posted Date

Sep 7, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical CenterPrincipal Investigator

Lead Sponsor

Wolfson Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor and vice versa.

Detailed Description

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Babies and small children 1-24 months	Device: WEEM - Wheezy Monitoring
B		Children 2-18 years old	Device: WEEM - Wheezy Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WEEM - Wheezy Monitoring	Device	loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.	A B

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children 1 month - 18 years old
Difficult to treat asthma
Difficult to treat cough
Difficult to treat other respiratory symptoms

Exclusion Criteria:

Children on artificial ventilation
Children not compliant with PH-Metria and/or WEEM

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Months

Standard Ages

Child

Study Population

We studied 23 consecutive Difficult to treat infants and children suspected of suffering from both RS and GER with chronic respiratory symptoms. However, four dropted due to technical problems wiht the equipment. In 19 patients We fully analyzed the respiratory sounds one minute during and one minute before and one minute after each GER episode, and in all parental markings of cough.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avigdor Mandelberg, MD	Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel		Holon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D003371	Cough
D012135	Respiratory Sounds

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided