Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: Intubation with a cuffed ET Tube Procedure: CT scan Radiation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Quantitative CT air trapping & airway measurements [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
- Functional residual capacity (FRC) & Lung Clearance Index (LCI). [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
- Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI. [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
- Correlation between LCI and quantitative air trapping [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
- Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 3 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
infants/young children with cystic fibrosis, primary ciliary dyskinesia, or other chronic lung disease, followed at our CF Center or Pulmonary Clinics
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.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Terry Earl Robinson | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01158495 History of Changes |
| Other Study ID Numbers: | PEDSVAR0009, SU-07062010-6488 |
| Study First Received: | July 6, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Diseases Lung Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013