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

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ClinicalTrials.gov Identifier: NCT00512382
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Asthma Cough Wheezing Device: WEEM - Wheezy Monitoring

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 Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring
Study Start Date : March 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Groups and Cohorts
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Group/Cohort Intervention/treatment
A
Babies and small children 1-24 months
 Device: WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
B
Children 2-18 years old
 Device: WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512382


Locations
Israel
Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Study Director: Avigdor Mandelberg, MD Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv
More Information
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Responsible Party: Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT00512382     History of Changes
Other Study ID Numbers: 688 special
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Avigdor Mandelberg, Wolfson Medical Center:
GER Gastrointestinal reflux
Aspiration
ASHTMA
COUGH
 WHEEZE
PH-IMPEDANCE
WEEM Wheezy Monitor

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms