The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
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| ClinicalTrials.gov Identifier: NCT00512382 |
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Recruitment Status
:
Completed
First Posted
: August 7, 2007
Last Update Posted
: September 7, 2011
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Sponsor:
Wolfson Medical Center
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center
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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 |
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 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
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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A
Babies and small children 1-24 months
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Device: WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
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B
Children 2-18 years old
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Device: WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
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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
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 |
| 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:
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GER Gastrointestinal reflux Aspiration ASHTMA COUGH |
WHEEZE PH-IMPEDANCE WEEM Wheezy Monitor |
Additional relevant MeSH terms:
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Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms |