Controlled Ventilation CT in CF Infants

NCT ID: NCT01200888

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-06-30

Brief Summary

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The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. 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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Infants and young children (age \~ 2/3 months to \< 5 years)
2. Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
3. Informed consent by parent or legal guardian.
4. Ability to comply with study visit procedures as judged by the investigator.

Exclusion Criteria

1. Acute wheezing and/or respiratory distress at either 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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Terry Robinson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Earl Robinson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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eProt #17572

Identifier Type: -

Identifier Source: secondary_id

SU-09092010-6830

Identifier Type: -

Identifier Source: org_study_id

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