Recruiting

Bethanechol

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT05299008

Conditions

Tracheobronchomalacia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Bethanechol

Study Details

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 investigators hypothesize that work of breathing will be improved in infants with tracheobronchomalacia estimated by a 20% mean decrease in swing Edi following initiation of bethanechol.

Conditions

Tracheobronchomalacia

Study ID

NCT05299008

Start date

Aug 11, 2022

Status verified date

Jan, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants with diagnosis of tracheobronchomalacia treated with bethanechol

Infants with a diagnosis of tracheobronchomalacia by dynamic computed tomography and showing > 50% cross-sectional diameter collapse at 40 to 60 post menstrual age

Interventions

Bethanechol

Infants whom will be treated with bethanechol for tracheobronchomalacia in level IV center Neonatal Intensive Care Unit.

Primary outcome measure

  • 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. [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Charles P Pugh, MD

9013352402cpugh2@uams.edu

David Matlock, MD

3184589097dmatlock@uams.edu

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Charles P Pugh, MD

901-335-2402cpugh2@uams.edu

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Jan 30, 2024

Last verified

Jan, 2024

Keywords

  • bethanechol
  • swing Edi
  • Bronchoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2024-01-30.