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Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158495
First Posted: July 8, 2010
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
To implement a new method of performing chest CT imaging in young children at Packard Children's Hospital entitled controlled ventilation infant/young child chest CT scanning. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.

Condition Intervention
Lung Cancer Procedure: Intubation with a cuffed ET Tube Procedure: CT scan Radiation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differentiating Outcome Measures in Infant and Early Childhood Lung Disease Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Quantitative CT air trapping & airway measurements [ Time Frame: 6 mo ]

Secondary Outcome Measures:
  • Functional residual capacity (FRC) & Lung Clearance Index (LCI). [ Time Frame: 6 mo ]
  • Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI. [ Time Frame: 6 mo ]
  • Correlation between LCI and quantitative air trapping [ Time Frame: 6 mo ]
  • Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC [ Time Frame: 6 mo ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants/young children with cystic fibrosis, primary ciliary dyskinesia, or other chronic lung disease, followed at our CF Center or Pulmonary Clinics
Criteria

Inclusion Criteria:1) Infants and young children (age <= 3 months to < 5 years) and either 2) or 3) below.

2) Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia, bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a pediatric pulmonologist at LPCH.

3) Oncology condition (e.g. young children with or without cancer, who are being screened for lung metastasis) and are being followed by pediatric oncologists at LPCH.

4) For minors, informed consent by parent or legal guardian.

5) Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria:1) Acute wheezing and/or respiratory distress at Study visit.

2) Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.

3) Oxygen saturation < 90% on room air at study visit.

4) Any medical condition that in the opinion of the investigator precludes subject participation.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158495


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Terry Earl Robinson Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01158495     History of Changes
Other Study ID Numbers: PEDSVAR0009
SU-07062010-6488 ( Other Identifier: Stanford University )
First Submitted: July 6, 2010
First Posted: July 8, 2010
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases