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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01158495
First received: July 6, 2010
Last updated: April 1, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Quantitative CT air trapping & airway measurements [ Time Frame: 6 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

infants/young children with cystic fibrosis, primary ciliary dyskinesia, or other chronic lung disease, followed at our CF Center or Pulmonary Clinics

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01158495

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014