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

This study has been completed.
Sponsor:
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
  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 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
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

Additional relevant MeSH terms:
Asthma
Cough
Signs and Symptoms, Respiratory
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014