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

NCT00512382 | Completed DMC

• 1 other identifier: 688 special
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Cough; Wheezing

Keywords

GER Gastrointestinal reflux; Aspiration; ASHTMA; COUGH; WHEEZE; PH-IMPEDANCE; WEEM Wheezy Monitor

Study Arms (2)

A

Babies and small children 1-24 months

Device: WEEM - Wheezy Monitoring

B

Children 2-18 years old

Device: WEEM - Wheezy Monitoring

Interventions

WEEM - Wheezy Monitoring DEVICE

loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

A; B

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Children 1 month - 18 years old
• Difficult to treat asthma
• Difficult to treat cough
• Difficult to treat other respiratory symptoms

You may not qualify if:

• Children on artificial ventilation
• Children not compliant with PH-Metria and/or WEEM

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

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

Holon, Israel

Location

MeSH Terms

Conditions

Asthma; Cough; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Avigdor Mandelberg, MD

  Edith Wolfson Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel aviv

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Pulmonry Unit

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

IL (1)