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OpenTrials
Completed

NCT Number: NCT01158495

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

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.

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Key information

Conditions

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

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Ability to comply with study visit procedures as judged by the investigator. Exclusion Criteria:1) Acute wheezing and/or respiratory distress at Study visit.
  • 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.

Treatment and study plan

Intubation with a cuffed ET Tube

Procedure

CT scan Radiation

Procedure

Primary outcomes

  1. Quantitative CT air trapping & airway measurements

    Time frame: 6 mo

Secondary outcomes

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

    Time frame: 6 mo

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

    Time frame: 6 mo

  3. Correlation between LCI and quantitative air trapping

    Time frame: 6 mo

  4. Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC

    Time frame: 6 mo

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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