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

This study is currently recruiting participants.

Verified by Wolfson Medical Center, August 2007

Sponsored by:	Wolfson Medical Center
Information provided by:	Wolfson Medical Center
ClinicalTrials.gov Identifier:	NCT00512382

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 obsevational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurments of GER and Wheezy monitoring (WEEM) that records simultanously wheeze and cough noises. Both modaliries will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the posible precipitating factor and vice versa.

Condition	Intervention
Asthma Cough Wheezing	Device: WEEM - Wheezy Monitoring

MedlinePlus related topics: Asthma Cough

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title:	The Nature of Reflux-Respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring

Further study details as provided by Wolfson Medical Center:

Study Start Date:

March 2007

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

Eligibility

Ages Eligible for Study:	1 Month to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512382

Contacts

Contact: Avigdor Mandelberg, MD

972-2-786000

avigdorm@netvision.net.il

Locations

Israel
Wolfson Medical center and Sackler School of Medicine, Tel Aviv University, Tel	Recruiting
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

Study ID Numbers:	688 special
Study First Received:	August 6, 2007
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00512382
Health Authority:	Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Wolfson Medical Center:

GER Gastrointestinal reflux
Aspiration
ASHTMA
COUGH

WHEEZE
PH-IMPEDANCE
WEEM Wheezy Monitor

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Sounds
Signs and Symptoms, Respiratory
Cough
Asthma

ClinicalTrials.gov processed this record on January 16, 2009