Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing

Lung Cancer Clinical Trial

Official title:

Differentiating Outcome Measures in Infant and Early Childhood Lung Disease Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158495
• Other study ID #: PEDSVAR0009
• Secondary ID: SU-07062010-6488
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: April 1, 2013
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To implement a new method of performing chest CT imaging in young children at Packard Children's Hospital entitled controlled ventilation infant/young child chest CT scanning. 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: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:1) Infants and young children (age <= 3 months to < 5 years) and either 2) or 3) below.

2) Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia, bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a pediatric pulmonologist at LPCH.

3) Oncology condition (e.g. young children with or without cancer, who are being screened for lung metastasis) and are being followed by pediatric oncologists at LPCH.

4) For minors, informed consent by parent or legal guardian.

5) Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria:1) Acute wheezing and/or respiratory distress at 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Diseases

Intervention

Procedure:
• Intubation with a cuffed ET Tube

• CT scan Radiation

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 CT air trapping & airway measurements		6 mo	No
Secondary	Functional residual capacity (FRC) & Lung Clearance Index (LCI).		6 mo	No
Secondary	Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI.		6 mo	No
Secondary	Correlation between LCI and quantitative air trapping		6 mo	No
Secondary	Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC		6 mo	No