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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT00512382
First received: August 6, 2007
Last updated: September 4, 2011
Last verified: September 2011

August 6, 2007
September 4, 2011
March 2007
March 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00512382 on ClinicalTrials.gov Archive Site
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The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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.

  • Asthma
  • Cough
  • Wheezing
Device: WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
  • A
    Babies and small children 1-24 months
    Intervention: Device: WEEM - Wheezy Monitoring
  • B
    Children 2-18 years old
    Intervention: Device: WEEM - Wheezy Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00512382
688 special
Yes
Avigdor Mandelberg, Wolfson Medical Center
Wolfson Medical Center
Not Provided
Study Director: Avigdor Mandelberg, MD Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv
Wolfson Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP