Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing

Stanford University1 site in 1 country1 target enrollmentSeptember 1, 2015

ConditionsCystic Fibrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Stanford University
Enrollment: 1
Locations: 1
Primary Endpoint: Quantitative Air Trapping, A2 & A3
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2015

End Date

June 30, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Terry Robinson

Associate Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Acute wheezing and/or respiratory distress at either study visit.
•Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
•Oxygen saturation \< 90% on room air at study visit.
•Any medical condition that in the opinion of the investigator precludes subject participation.

Outcomes

Primary Outcomes

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)

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 (%)