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Controlled Ventilation CT in CF Infants

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Terry Robinson, Stanford University
ClinicalTrials.gov Identifier:
NCT01200888
First received: September 10, 2010
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Quantitative Air Trapping, A2 & A3 [ Time Frame: Baseline & F/U ] [ Designated as safety issue: No ]
    Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 & Measure A3 (% of segmented total lung)

  • Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area % [ Time Frame: Baseline & F/U ] [ Designated as safety issue: No ]
    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:
  • FEV 0.5 sec [ Time Frame: Baseline & F/U ] [ Designated as safety issue: No ]
    FEV 0.5sec = % predicted

  • FEF 85% [ Time Frame: Baseline & F/U ] [ Designated as safety issue: No ]
    FEF 85% (% predicted)

  • FEF25-75% [ Time Frame: Baseline & F/U ] [ Designated as safety issue: No ]
    FEF25-75% (% predicted)


Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200888

Contacts
Contact: Colleen Dunn (650) 736-0388 cedunn@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Colleen Dunn     650-736-0388     cedunn@stanford.edu    
Sub-Investigator: Beverley Newman            
Sub-Investigator: Colleen Dunn, RRT, CCRC            
Sub-Investigator: Rebecca Claure            
Sub-Investigator: Carlos Milla            
Sub-Investigator: Zoe Davies RN            
Sub-Investigator: Dr. Jacquelyn Marie Zirbes DNP            
Principal Investigator: Yan Ki Angela Leung            
Principal Investigator: Terry Earl Robinson            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Terry Earl Robinson Stanford University
  More Information

No publications provided

Responsible Party: Terry Robinson, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01200888     History of Changes
Other Study ID Numbers: SU-09092010-6830, eProt #17572
Study First Received: September 10, 2010
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013