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

NCT01158495 | Completed

• 2 other identifiers: PEDSVAR0009SU-07062010-6488
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Quantitative CT air trapping & airway measurements

  6 mo

Secondary Outcomes (4)

• Functional residual capacity (FRC) & Lung Clearance Index (LCI).

  6 mo

• Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI.

  6 mo

• Correlation between LCI and quantitative air trapping

  6 mo

• Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC

  6 mo

Interventions

Intubation with a cuffed ET Tube PROCEDURE

CT scan Radiation PROCEDURE

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• \) Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
• \) Oxygen saturation \< 90% on room air at study visit.
• \) Any medical condition that in the opinion of the investigator precludes subject participation.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Intubation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Terry Earl Robinson

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: January 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)