Controlled Ventilation CT in CF Infants
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Information provided by (Responsible Party):
Terry Robinson, Stanford University
First received: September 10, 2010
Last updated: December 14, 2012
Last verified: December 2012
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||2 Months to 5 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Young children with cystic fibrosis at Packard Children's Hospital.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200888
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|Contact: Colleen Dunn 650-736-0388 email@example.com |
|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 |
||Terry Earl Robinson
No publications provided
||Terry Robinson, Associate Professor, Stanford University
History of Changes
|Other Study ID Numbers:
||SU-09092010-6830, eProt #17572
|Study First Received:
||September 10, 2010
||December 14, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases