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

Asthma Clinical Trial

Official title:

The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512382
• Other study ID #: 688 special
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: September 4, 2011
• Start date: March 2007
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 18 Months

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Cough
• Signs and Symptoms, Respiratory
• Wheezing

Intervention

Device:
• WEEM - Wheezy Monitoring
loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

Locations

Country	Name	City	State
Israel	Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel,