Controlled Ventilation CT in CF Infants
Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
2 other identifiers
observational
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedApril 23, 2018
April 1, 2018
1.8 years
September 10, 2010
April 20, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Quantitative Air Trapping, A2 & A3
Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 \& Measure A3 (% of segmented total lung)
Baseline & F/U
Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area %
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 (%)
Baseline & F/U
Secondary Outcomes (3)
FEV 0.5 sec
Baseline & F/U
FEF 85%
Baseline & F/U
FEF25-75%
Baseline & F/U
Eligibility Criteria
Young children with cystic fibrosis at Packard Children's Hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry Earl Robinson
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 14, 2010
Study Start
September 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 30, 2017
Last Updated
April 23, 2018
Record last verified: 2018-04