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Determinants of Early Cystic Fibrosis Lung Disease

NCT03579173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2022-06-22

No results posted yet for this study

Summary

The overall objective of this study is to determine the impact early nutritional and respiratory indices have on early CF lung disease. This knowledge will guide clinical management of infants with CF, who are now primarily diagnosed through newborn screening.

Conditions

  • Cystic Fibrosis in Children

Interventions

DIAGNOSTIC_TEST

Infant PFT

Assessed through the raised volume rapid thoracoabdominal compression technique and plethysmography

DIAGNOSTIC_TEST

Lung Clearance Index

The Lung Clearance Index is derived from the Multiple Breath Washout test. It is the cumulative exhaled volume (the volume of gas needed to wash out resident gas mixture out of the lungs) divided by the FRC. The FRC is the amount of air left in the lungs after normal exhalation.

DIAGNOSTIC_TEST

Passive tidal breathing

During quiet sleep, tidal breathing flow-volume curves are obtained. The tPEF/tE is calculated by taking the time it takes to reach peak expiratory flow divided by the total peak expiratory time.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Heather Muston, MD · Indiana University

Eligibility

Min Age
1 Month
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2019-02-06
Completion
2019-02-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579173 on ClinicalTrials.gov