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Completed

NCT Number: NCT00512382

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Cough Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Age range

1 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Holon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WEEM - Wheezy Monitoring

Device

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

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2007
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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