Status:

RECRUITING

The Effect of Bethanechol on Tracheobronchomalacia

Lead Sponsor:

Arkansas Children's Hospital Research Institute

Conditions:

Tracheobronchomalacia

Eligibility:

All Genders

Brief Summary

The primary aim of this study is to determine if work of breathing estimated using swing Edi will be improved following initiation of bethanechol in infants with tracheobronchomalacia. The investigato...

Detailed Description

Tracheobronchomalacia (TBM) is characterized by dynamic airway collapse resulting from flaccidity of smooth trachealis muscles, and the incidence in infants has been estimated to be as high as 16-50%....

Eligibility Criteria

Inclusion

  • Infants with a diagnosis of tracheobronchomalacia by dynamic computed tomography and showing \> 50% cross-sectional diameter collapse at 40 to 60 post menstrual age and for whom will be treatment with bethanechol in level IV center Neonatal Intensive Care Unit.

Exclusion

  • Infants with diagnosis of tracheobronchomalacia by dynamic computed tomography with \< 50% cross-sectional diameter collapse at 40 to 60 post menstrual age, or infants in which the medical team has not made the decision to start bethanechol.
  • Patients with fixed tracheomalacia or bronchomalacia due to external compression of airways.

Key Trial Info

Start Date :

August 11 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2024

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05299008

Start Date

August 11 2022

End Date

June 30 2024

Last Update

January 30 2024

Active Locations (1)

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1

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202