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VRI in Children With Acute Respiratory Symptoms.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01279863
First received: January 18, 2011
Last updated: August 11, 2011
Last verified: May 2010
  Purpose

The VRI technology provides a radiation free dynamic image of the lung, by using a combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm. The aim of the study is to determine if the VRI examination may contribute to the diagnosis and follow up of pneumonia in children, and therefore reduce the number of chest radiographs and the exposure to ionizing radiation. Children referred by ED for chest x-ray,for the evaluation of pneumonia, will undergo VRI as well. The two modalities will be read independently and then the findings will be compared, in order to asses the potential role of the VRI to the management of pneumonia in children.


Condition
Pneumonia
Fever

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children, 3-18 years old

Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be entered into the study:

  1. Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
  2. Boy or girl in the age range of 3-18 years.
  3. Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
  4. Patient referred by ED physician and presented for CXR.

Exclusion Criteria:

Any of the following will exclude the patient from study:

  1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
  2. Potentially contagious skin lesion on the back;

4. Subject has had lung surgery; 5. Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.

  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: NCT01279863

Contacts
Contact: Liora Kornreich, MD liorak@post.tau.ac.il

Locations
Israel
Schneider medical center of Israel, Imaging Department
Petah-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Liora Kornreich, MD Schneider Children's Medical Center, Israel
Study Chair: Gadi Horev, MD Schneider Children's Medical Center, Israel
Study Chair: Michael Schwarz, MD Schneider Children's Medical Center, Israel
Study Chair: Osnat Konen, MD Schneider Children's Medical Center, Israel
Study Chair: Nadine Berkowitz, MD Schneider Children's Medical Center, Israel
Study Chair: Yehezkel Waisman, MD Schneider Children's Medical Center, Israel
  More Information

No publications provided

Responsible Party: Liora Kornreich, MD, Schneider children's Medical center of Israel
ClinicalTrials.gov Identifier: NCT01279863     History of Changes
Other Study ID Numbers: 5500-DB048
Study First Received: January 18, 2011
Last Updated: August 11, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Pneumonia
Cough
Shortness of breath
VRI

Additional relevant MeSH terms:
Pneumonia
Signs and Symptoms, Respiratory
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014