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The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
This study has been completed.
Sponsor:
Wolfson Medical Center
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
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Purpose
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 | Intervention |
|---|---|
| Asthma Cough Wheezing | Device: WEEM - Wheezy Monitoring |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Avigdor Mandelberg, Wolfson Medical Center:
| Enrollment: | 15 |
| Study Start Date: | March 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512382
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical Center |
| ClinicalTrials.gov Identifier: | NCT00512382 History of Changes |
| Other Study ID Numbers: |
688 special |
| Study First Received: | August 6, 2007 |
| Last Updated: | September 4, 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 |
ClinicalTrials.gov processed this record on July 26, 2017