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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01158495

Enrollment

Registered

2010-07-08

Start date

2009-01-31

Completion date

2012-07-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

PROCEDUREIntubation with a cuffed ET Tube

PROCEDURECT scan Radiation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Quantitative CT air trapping & airway measurements	6 mo

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026