Evaluating the effects of bethanechol on breathing in infants with tracheobronchomalacia
The Effect of Bethanechol on Work of Breathing and Expiratory Tracheal Collapse in Infants With Tracheobronchomalacia Measured by Electrical Activity of the Diaphragm and Bronchoscopy
This study is testing if a medication called bethanechol can help improve breathing for infants with tracheobronchomalacia by making it easier for them to breathe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT05299008 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether the administration of bethanechol can improve the work of breathing in infants diagnosed with tracheobronchomalacia. The researchers hypothesize that a 20% mean decrease in swing Edi, a measure of breathing effort, will be observed after starting treatment with bethanechol. Tracheobronchomalacia is a condition characterized by airway collapse, leading to increased respiratory effort and prolonged hospitalization. The study will involve infants who have been diagnosed with significant airway collapse and are receiving care in a specialized neonatal intensive care unit.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with tracheobronchomalacia showing more than 50% airway collapse.
Not a fit: Patients with less than 50% airway collapse or those with fixed airway obstructions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the respiratory effort and improve clinical outcomes for infants with tracheobronchomalacia.
How similar studies have performed: While there have been no large trials demonstrating the efficacy of bethanechol for this condition, animal studies suggest potential benefits, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Little Rock, Arkansas
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Charles P Pugh, MD — Arkansas Children's Hospital Research Institute
- Study coordinator: Charles P Pugh, MD
- Email: cpugh2@uams.edu
- Phone: 9013352402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.