Controlled Ventilation CT in CF Infants

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01200888
• Other study ID #: SU-09092010-6830
• Secondary ID: eProt #17572
• Status: Terminated
• First received: September 10, 2010
• Last updated: April 20, 2018
• Start date: September 1, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 30, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	FEV 0.5 sec	FEV 0.5sec = % predicted	Baseline & F/U
Secondary	FEF 85%	FEF 85% (% predicted)	Baseline & F/U
Secondary	FEF25-75%	FEF25-75% (% predicted)	Baseline & F/U