Controlled Ventilation CT in CF Infants

Terminated

• Conditions: Cystic Fibrosis

• Registration Number: NCT01200888
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Study Start: 2015-09-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative Air Trapping, A2 & A3	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 %	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

Name	Time	Method
FEF 85%	Baseline & F/U	FEF 85% (% predicted)
FEF25-75%	Baseline & F/U	FEF25-75% (% predicted)
FEV 0.5 sec	Baseline & F/U	FEV 0.5sec = % predicted

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States