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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring

Conditions
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Asthma, Cough, Wheezing

Intervention / Treatment
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* Device: WEEM - Wheezy Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Babies and small children 1-24 months | Device: WEEM - Wheezy Monitoring<br>* loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.<br>|
| B<br>Children 2-18 years old | Device: WEEM - Wheezy Monitoring<br>* loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GER Gastrointestinal reflux, Aspiration, ASHTMA, COUGH, WHEEZE, PH-IMPEDANCE, WEEM Wheezy Monitor