AsthmaNCT00512382
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies
An observational study of Asthma and Cough, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 monthsHealthy volunteers can take part
- What is being tested?
- WEEM - Wheezy Monitoring
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children 1 month - 18 years old
- Difficult to treat asthma
- Difficult to treat cough
- Difficult to treat other respiratory symptoms
Who cannot join
- Children on artificial ventilation
- Children not compliant with PH-Metria and/or WEEM
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel
Holon
About this study
Official title: 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.
Read the 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.
- Being tested
- WEEM - Wheezy Monitoring
- Keywords
- GER Gastrointestinal reflux, Aspiration, ASHTMA, COUGH, WHEEZE, PH-IMPEDANCE, WEEM Wheezy Monitor
- Medical subject headings
- Asthma, Cough, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEEM - Wheezy MonitoringDevice
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.
| Study group | Role | What they receive |
|---|---|---|
| A | Babies and small children 1-24 months Receives: Device: WEEM - Wheezy Monitoring | |
| B | Children 2-18 years old Receives: Device: WEEM - Wheezy Monitoring |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Avigdor Mandelberg, Wolfson Medical Center
- Investigators
- Avigdor Mandelberg, MD, Study director, Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512382
- Sponsor's protocol ID
- 688 special
- Status last verified
- Sep 2011
- First submitted
- 6 Aug 2007
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring
- ClinicalTrials.gov ID
- NCT00512382
- Acronym / sponsor ID
- 688 special
- Keywords
- GER Gastrointestinal reflux, Aspiration, ASHTMA, COUGH, WHEEZE, PH-IMPEDANCE, WEEM Wheezy Monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Mar 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: WEEM - Wheezy MonitoringBabies and small children 1-24 months |
| B | – | Device: WEEM - Wheezy MonitoringChildren 2-18 years old |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Children 1 month - 18 years old
- Difficult to treat asthma
- Difficult to treat cough
- Difficult to treat other respiratory symptoms
Key exclusion criteria (2 listed)
- Children on artificial ventilation
- Children not compliant with PH-Metria and/or WEEM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEEM - Wheezy Monitoringloudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance. | Device | A, B |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avigdor Mandelberg, MD study director
Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Cough, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.