Clinical trial NCT00512382: The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
Official title: The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Cough
Wheezing
Keywords: GER Gastrointestinal reflux
Aspiration
ASHTMA
COUGH
WHEEZE
PH-IMPEDANCE
WEEM Wheezy Monitor
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-07
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel
Study officials:
affiliation: Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv
name: Avigdor Mandelberg, MD
role: STUDY_DIRECTOR
References: