Status:

ACTIVE_NOT_RECRUITING

Pulmonary Function Using Non-invasive Forced Oscillometry

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Infant, Premature, Diseases

Infant, Newborn, Diseases

Eligibility:

All Genders

1-2 years

Phase:

NA

Brief Summary

The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dyspla...

Detailed Description

TremoFlo™ N-100 (For Investigational Use Only) Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) is a technology for measuring lung mechanics without patie...

Eligibility Criteria

Inclusion

  • Infants with gestational age at least 22 weeks at birth
  • Infants off ventilator/continuous positive airway pressure ≥ 12 hours
  • Infants whose parents/legal guardians have provided consent

Exclusion

  • Infants with major malformation
  • Infants with a neuromuscular condition that affects respiration
  • Infants with terminal illness
  • Infants with a decision made to withhold or limit support

Key Trial Info

Start Date :

December 6 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

1098 Patients enrolled

Trial Details

Trial ID

NCT03346343

Start Date

December 6 2017

End Date

May 1 2027

Last Update

March 17 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249