Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

NCT ID: NCT01414322

Last Updated: 2011-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Bronchiolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Patients ages 0 - 3

No interventions assigned to this group

Group 2: Patients ages 3 - 7

No interventions assigned to this group

Group 3: Patients ages 7 - 15

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patient is admitted to the ER with shortness of breath
* patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:

* asthma management protocol
* bronchiolitis management protocol
* ages 0 - 15
* patient's parent/guardian is able to comprehend and give informed consent for participating in the study

Exclusion Criteria

* patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
* patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
* ventilated patients, while ventilated
* chest skin lesions
* cystic fibrosis
* hemodynamic instability
* patient's parent/guardian objects to the study protocol
* concurrent participation in any other clinical study
* physician objection
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

KarmelSonix Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

KarmelSonix Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eitan Kerem, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Center Mt. Scopus, Jerusalem, Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Center Mt. Scopus

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Noam Gavriely, MD PhD

Role: CONTACT

+972 54 466 1337

Ezekiel Balouka, MSc

Role: CONTACT

+972 52 312 1098

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KSI-IL-HHZ-ER-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hypertonic Saline for Acute Bronchiolitis
NCT01247064 COMPLETED PHASE4