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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00512382
Other study ID # 688 special
Secondary ID
Status Completed
Phase N/A
First received August 6, 2007
Last updated September 4, 2011
Start date March 2007
Est. completion date September 2011

Study information

Verified date September 2011
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial 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.


Description:

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.However, If cough/wheeze precedes GER recordings it points to cough/wheeze being the possible precipitating factor. The recordings will be investigated 1 minute before and one minute after each event.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date September 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Month to 18 Months
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

Locations

Country Name City State
Israel Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel Holon

Sponsors (1)

Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

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