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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01200888

Enrollment

Registered

2010-09-14

Start date

2015-09-01

Completion date

2017-06-30

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results