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

Completed

• Conditions: Asthma; Cough; Wheezing
• Interventions: Device: WEEM - Wheezy Monitoring

• Registration Number: NCT00512382
• Lead Sponsor: Wolfson Medical Center

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

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Primary Completion: 2011-03
• Status Verified: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-04
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	WEEM - Wheezy Monitoring	Babies and small children 1-24 months
B	WEEM - Wheezy Monitoring	Children 2-18 years old

Trial Locations

Locations (1)

Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel; 🇮🇱 Holon, Israel