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Controlled Ventilation CT in CF Infants

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ClinicalTrials.gov Identifier: NCT01200888
Recruitment Status : Terminated
First Posted : September 14, 2010
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Terry Robinson, Stanford University

Brief Summary:
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. 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 or disease
Cystic Fibrosis

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Quantitative Air Trapping, A2 & A3 [ Time Frame: Baseline & F/U ]
    Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 & Measure A3 (% of segmented total lung)

  2. Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area % [ Time Frame: Baseline & F/U ]
    Quantitative Chest CT airway measurements by CT Post-Processing. AWT/TAD = Airway Wall Thickness/Total Airway Diameter LD/TAD = Lumen Diameter/Total Airway Diameter Wall Area % = Wall Area/Total Airway Area (%)


Secondary Outcome Measures :
  1. FEV 0.5 sec [ Time Frame: Baseline & F/U ]
    FEV 0.5sec = % predicted

  2. FEF 85% [ Time Frame: Baseline & F/U ]
    FEF 85% (% predicted)

  3. FEF25-75% [ Time Frame: Baseline & F/U ]
    FEF25-75% (% predicted)



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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young children with cystic fibrosis at Packard Children's Hospital.
Criteria

Inclusion Criteria:

  1. Infants and young children (age ~ 2/3 months to < 5 years)
  2. Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
  3. Informed consent by parent or legal guardian.
  4. Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria:

  1. Acute wheezing and/or respiratory distress at either 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.

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): NCT01200888


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

Responsible Party: Terry Robinson, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01200888     History of Changes
Other Study ID Numbers: SU-09092010-6830
eProt #17572
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases