TracheobronchomalaciaNCT05299008
The Effect of Bethanechol on Tracheobronchomalacia
An observational study of Tracheobronchomalacia, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheobronchomalacia
- What is being tested?
- Bethanechol
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient infants in a level IV Neonatal Intensive Care Unit.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Charles P Pugh, MD, 901-335-2402, cpugh2@uams.edu
About this study
Official title: 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
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.
Read the 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%. Tracheal collapse results in an increase in work of breathing (WOB) which leads to prolonged ventilatory support, increased caloric needs, and prolonged hospitalization. Clinical signs of increased WOB include nasal flaring, increased use of accessory muscles, and paradoxical movements of the rib cage and abdominal wall. Compared with infants with normal airways, infants with TBM have a higher resistive WOB and require increased respiratory support to help attenuate the respiratory work.
Currently, there are no pharmacologic treatment options approved by the Food and Drug Administration for the treatment of TBM. Animal models have shown that muscarinic agonists may improve the tone of the trachealis muscle and airway mechanics. These physiologic improvements have led to the rationale behind use of the long-acting muscarinic agonist, bethanechol, in the treatment of children with tracheomalacia despite no large trials to demonstrate efficacy. By improving trachealis tone and airway mechanics, infants may benefit from an overall decrease in their resistive WOB leading to improved clinical outcomes.
Measurement of actual WOB can be difficult, invasive, and not easily achieved in neonates, however it can be estimated. One method that has been successfully used to estimate WOB in neonates is by swing electrical activity of the diaphragm (Edi) by neurally adjusted ventilatory assist (NAVA). Swing Edi use in NAVA is the difference between the resting tonic activity of the diaphragm (Edi min) and the peak activity of the diaphragm (Edi max) measured by an Edi catheter. By using Swing Edi as a marker for WOB, the investigators propose a methodology to evaluate a physiologic improvement in infants after starting a pharmacologic treatment for TBM.
Though increased WOB is the result of decreased trachealis tone and tracheal collapse, the most accurate method of identifying airway collapse is by direct visualization of the airways. Bronchoscopy is able to give qualitative and semi quantitative impressions of airway collapsibility and has consistently demonstrated a highly favorable safety profile in infants. By performing bronchoscopy before and after bethanechol initiation a direct change may be noted from medical management.
As such, the investigators hypothesize that WOB estimated by swing Edi and tracheal tone identified by direct visualization bronchoscopy will be improved following initiation of bethanechol in infants with tracheobronchomalacia.
- Conditions
- Tracheobronchomalacia
- Being tested
- Bethanechol
- Keywords
- bethanechol, swing Edi, Bronchoscopy
- Medical subject headings
- Tracheobronchomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BethanecholDrug
Also called bethanechol chloride
Infants whom will be treated with bethanechol for tracheobronchomalacia in level IV center Neonatal Intensive Care Unit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bethanechol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Swing Edi data will be collected continuously by downloading ventilator trends from the 24 hours prior to initiation of bethanechol in infants and subsequently downloaded every 48-72 hours for 7 days after starting bethanechol.
Measured: 7 days
Secondary outcomes (5)
Determining if there is a direct visual change in trachealis tone determined by bronchoscopy following bethanechol initiation in infants with tracheobronchomalacia.
A baseline flexible bronchoscopy prior to starting of bethanechol followed by a repeat flexible bronchoscopy at days 7-14 of post bethanechol treatment.
Measured: Day 1 and then at 7-14 days
Evaluating for change in regional impedance variation by use of Electrical Impedance Tomography
Electrical Impedance Technology (EIT) is a tool used to monitor regional changes in ventilation and lung mechanics.
Measured: Collect EIT data 24 hours prior to starting bethanechol and on day 7 after starting bethanechol treatment.
Evaluating for change in a Pulmonary Severity Score
Evaluate a change in a Pulmonary Severity Score (Madden 2005). The pulmonary severity score is defined as the fraction of inspired oxygen (FIO2) x (support) x (medications).
Measured: Data collected 40 weeks to 60 weeks postmenstrual age
Investigating for change in number of apnea/bradycardia/desaturation events, pain/sedation scores, and doses of sedation medications following bethanechol initiation in infants with tracheobronchomalacia.
Data collected 40 weeks to 60 weeks postmenstrual age
Measured: Daily from 40 weeks to 60 weeks postmenstrual age
Assessing for side effects of bethanechol treatment such an increase in secretions, wheezing, or an increase in loose stools.
Collect the documented effects 7 days before and 14 days after bethanechol initiation.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start11 Aug 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TracheobronchomalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Preston Pugh, Arkansas Children's Hospital Research Institute
- Investigators
- Charles P Pugh, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299008
- Sponsor's protocol ID
- 274192
- Status last verified
- Jan 2024
- First submitted
- 18 Mar 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenholz SK, Hall RJ, Lilly JR, Shikes RH. Surgical implications of bronchopulmonary dysplasia. J Pediatr Surg. 1987 Dec;22(12):1132-6. doi: 10.1016/s0022-3468(87)80723-6.
PubMed 3440899Downing GJ, Kilbride HW. Evaluation of airway complications in high-risk preterm infants: application of flexible fiberoptic airway endoscopy. Pediatrics. 1995 Apr;95(4):567-72.
PubMed 7700760Gunatilaka CC, Higano NS, Hysinger EB, Gandhi DB, Fleck RJ, Hahn AD, Fain SB, Woods JC, Bates AJ. Increased Work of Breathing due to Tracheomalacia in Neonates. Ann Am Thorac Soc. 2020 Oct;17(10):1247-1256. doi: 10.1513/AnnalsATS.202002-162OC.
PubMed 32579852Wagner EM, Jacoby DB. Methacholine causes reflex bronchoconstriction. J Appl Physiol (1985). 1999 Jan;86(1):294-7. doi: 10.1152/jappl.1999.86.1.294.
PubMed 9887142Bass R, Santiago M, Smith L, Quinlan C, Panitch H, Giordano T, Piccione J. (2018). Bethanechol in Tracheomalacia: Two Case Series and a Review of the Literature. Pediatric Allergy, Immunology, and Pulmonology. 31:3, 180-183. https://doi.org/10.1089/ped.2018.0880
Bhutani VK, Koslo RJ, Shaffer TH. The effect of tracheal smooth muscle tone on neonatal airway collapsibility. Pediatr Res. 1986 Jun;20(6):492-5. doi: 10.1203/00006450-198606000-00002.
PubMed 2872649Panitch HB, Keklikian EN, Motley RA, Wolfson MR, Schidlow DV. Effect of altering smooth muscle tone on maximal expiratory flows in patients with tracheomalacia. Pediatr Pulmonol. 1990;9(3):170-6. doi: 10.1002/ppul.1950090309.
PubMed 1980538Hysinger E, Friedman N, Jensen E, Zhang H, Piccione J. Bronchoscopy in neonates with severe bronchopulmonary dysplasia in the NICU. J Perinatol. 2019 Feb;39(2):263-268. doi: 10.1038/s41372-018-0280-y. Epub 2018 Dec 5.
PubMed 30518799Madan A, Brozanski BS, Cole CH, Oden NL, Cohen G, Phelps DL. A pulmonary score for assessing the severity of neonatal chronic lung disease. Pediatrics. 2005 Apr;115(4):e450-7. doi: 10.1542/peds.2004-1293.
PubMed 15805348Nealon E, Rivera BK, Cua CL, Ball MK, Stiver C, Boe BA, Slaughter JL, Chisolm J, Smith CV, Cooper JN, Armstrong AK, Berman DP, Backes CH. Follow-up after Percutaneous Patent Ductus Arteriosus Occlusion in Lower Weight Infants. J Pediatr. 2019 Sep;212:144-150.e3. doi: 10.1016/j.jpeds.2019.05.070. Epub 2019 Jun 28.
PubMed 31262530Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.
PubMed 26178463Bergeron M, Cohen AP, Cotton RT. The Management of Cyanotic Spells in Children with Oesophageal Atresia. Front Pediatr. 2017 May 15;5:106. doi: 10.3389/fped.2017.00106. eCollection 2017.
PubMed 28555179Masters IB, Zimmerman PV, Pandeya N, Petsky HL, Wilson SB, Chang AB. Quantified tracheobronchomalacia disorders and their clinical profiles in children. Chest. 2008 Feb;133(2):461-7. doi: 10.1378/chest.07-2283. Epub 2007 Nov 7.
PubMed 17989148Wallis C, Alexopoulou E, Anton-Pacheco JL, Bhatt JM, Bush A, Chang AB, Charatsi AM, Coleman C, Depiazzi J, Douros K, Eber E, Everard M, Kantar A, Masters IB, Midulla F, Nenna R, Roebuck D, Snijders D, Priftis K. ERS statement on tracheomalacia and bronchomalacia in children. Eur Respir J. 2019 Sep 28;54(3):1900382. doi: 10.1183/13993003.00382-2019. Print 2019 Sep.
PubMed 31320455DeBoer EM, Prager JD, Kerby GS, Stillwell PC. Measuring Pediatric Bronchoscopy Outcomes Using an Electronic Medical Record. Ann Am Thorac Soc. 2016 May;13(5):678-83. doi: 10.1513/AnnalsATS.201509-576OC.
PubMed 26816220
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05299008
- Acronym / sponsor ID
- 274192
- Conditions
- Tracheobronchomalacia
- Keywords
- bethanechol, swing Edi, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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%. Tracheal collapse results in an increase in work of breathing (WOB) which leads to prolonged ventilatory support, increased caloric needs, and prolonged hospitalization. Clinical signs of increased WOB include nasal flaring, increased use of accessory muscles, and paradoxical movements of the rib cage and abdominal wall. Compared with infants with normal airways, infants with TBM have a higher resistive WOB and require increased respiratory support to help attenuate the respiratory work.
Currently, there are no pharmacologic treatment options approved by the Food and Drug Administration for the treatment of TBM. Animal models have shown that muscarinic agonists may improve the tone of the trachealis muscle and airway mechanics. These physiologic improvements have led to the rationale behind use of the long-acting muscarinic agonist, bethanechol, in the treatment of children with tracheomalacia despite no large trials to demonstrate efficacy. By improving trachealis tone and airway mechanics, infants may benefit from an overall decrease in their resistive WOB leading to improved clinical outcomes.
Measurement of actual WOB can be difficult, invasive, and not easily achieved in neonates, however it can be estimated. One method that has been successfully used to estimate WOB in neonates is by swing electrical activity of the diaphragm (Edi) by neurally adjusted ventilatory assist (NAVA). Swing Edi use in NAVA is the difference between the resting tonic activity of the diaphragm (Edi min) and the peak activity of the diaphragm (Edi max) measured by an Edi catheter. By using Swing Edi as a marker for WOB, the investigators propose a methodology to evaluate a physiologic improvement in infants after starting a pharmacologic treatment for TBM.
Though increased WOB is the result of decreased trachealis tone and tracheal collapse, the most accurate method of identifying airway collapse is by direct visualization of the airways. Bronchoscopy is able to give qualitative and semi quantitative impressions of airway collapsibility and has consistently demonstrated a highly favorable safety profile in infants. By performing bronchoscopy before and after bethanechol initiation a direct change may be noted from medical management.
As such, the investigators hypothesize that WOB estimated by swing Edi and tracheal tone identified by direct visualization bronchoscopy will be improved following initiation of bethanechol in infants with tracheobronchomalacia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with diagnosis of tracheobronchomalacia treated with bethanechol | – | Drug: BethanecholInfants with a diagnosis of tracheobronchomalacia by dynamic computed tomography and showing > 50% cross-sectional diameter collapse at 40 to 60 post menstrual age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient infants in a level IV Neonatal Intensive Care Unit.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BethanecholAlso: bethanechol chlorideInfants whom will be treated with bethanechol for tracheobronchomalacia in level IV center Neonatal Intensive Care Unit. | Drug | Infants with diagnosis of tracheobronchomalacia treated with bethanechol |
Primary outcome
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
Swing Edi data will be collected continuously by downloading ventilator trends from the 24 hours prior to initiation of bethanechol in infants and subsequently downloaded every 48-72 hours for 7 days after starting bethanechol.
5 secondary outcomes
Determining if there is a direct visual change in trachealis tone determined by bronchoscopy following bethanechol initiation in infants with tracheobronchomalacia.
Time frame: Day 1 and then at 7-14 days
Evaluating for change in regional impedance variation by use of Electrical Impedance Tomography
Time frame: Collect EIT data 24 hours prior to starting bethanechol and on day 7 after starting bethanechol treatment.
Evaluating for change in a Pulmonary Severity Score
Time frame: Data collected 40 weeks to 60 weeks postmenstrual age
Investigating for change in number of apnea/bradycardia/desaturation events, pain/sedation scores, and doses of sedation medications following bethanechol initiation in infants with tracheobronchomalacia.
Time frame: Daily from 40 weeks to 60 weeks postmenstrual age
Assessing for side effects of bethanechol treatment such an increase in secretions, wheezing, or an increase in loose stools.
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 3440899Greenholz SK, Hall RJ, Lilly JR, Shikes RH. Surgical implications of bronchopulmonary dysplasia. J Pediatr Surg. 1987 Dec;22(12):1132-6. doi: 10.1016/s0022-3468(87)80723-6.
- Background: PubMed 7700760Downing GJ, Kilbride HW. Evaluation of airway complications in high-risk preterm infants: application of flexible fiberoptic airway endoscopy. Pediatrics. 1995 Apr;95(4):567-72.
- Background: PubMed 32579852Gunatilaka CC, Higano NS, Hysinger EB, Gandhi DB, Fleck RJ, Hahn AD, Fain SB, Woods JC, Bates AJ. Increased Work of Breathing due to Tracheomalacia in Neonates. Ann Am Thorac Soc. 2020 Oct;17(10):1247-1256. doi: 10.1513/AnnalsATS.202002-162OC.
- Background: PubMed 9887142Wagner EM, Jacoby DB. Methacholine causes reflex bronchoconstriction. J Appl Physiol (1985). 1999 Jan;86(1):294-7. doi: 10.1152/jappl.1999.86.1.294.
- BackgroundBass R, Santiago M, Smith L, Quinlan C, Panitch H, Giordano T, Piccione J. (2018). Bethanechol in Tracheomalacia: Two Case Series and a Review of the Literature. Pediatric Allergy, Immunology, and Pulmonology. 31:3, 180-183. https://doi.org/10.1089/ped.2018.0880
- Background: PubMed 2872649Bhutani VK, Koslo RJ, Shaffer TH. The effect of tracheal smooth muscle tone on neonatal airway collapsibility. Pediatr Res. 1986 Jun;20(6):492-5. doi: 10.1203/00006450-198606000-00002.
- Background: PubMed 1980538Panitch HB, Keklikian EN, Motley RA, Wolfson MR, Schidlow DV. Effect of altering smooth muscle tone on maximal expiratory flows in patients with tracheomalacia. Pediatr Pulmonol. 1990;9(3):170-6. doi: 10.1002/ppul.1950090309.
- Background: PubMed 30518799Hysinger E, Friedman N, Jensen E, Zhang H, Piccione J. Bronchoscopy in neonates with severe bronchopulmonary dysplasia in the NICU. J Perinatol. 2019 Feb;39(2):263-268. doi: 10.1038/s41372-018-0280-y. Epub 2018 Dec 5.
- Background: PubMed 15805348Madan A, Brozanski BS, Cole CH, Oden NL, Cohen G, Phelps DL. A pulmonary score for assessing the severity of neonatal chronic lung disease. Pediatrics. 2005 Apr;115(4):e450-7. doi: 10.1542/peds.2004-1293.
- Background: PubMed 31262530Nealon E, Rivera BK, Cua CL, Ball MK, Stiver C, Boe BA, Slaughter JL, Chisolm J, Smith CV, Cooper JN, Armstrong AK, Berman DP, Backes CH. Follow-up after Percutaneous Patent Ductus Arteriosus Occlusion in Lower Weight Infants. J Pediatr. 2019 Sep;212:144-150.e3. doi: 10.1016/j.jpeds.2019.05.070. Epub 2019 Jun 28.
- Background: PubMed 26178463Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.
- Background: PubMed 28555179Bergeron M, Cohen AP, Cotton RT. The Management of Cyanotic Spells in Children with Oesophageal Atresia. Front Pediatr. 2017 May 15;5:106. doi: 10.3389/fped.2017.00106. eCollection 2017.
- Individual participant dataSharing planned: No
Related trials for Tracheobronchomalacia
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Recruiting
Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
Tracheobronchomalacia, Excessive Dynamic Airway Collapse
Recruiting
Bioresorbable Airway Splint Pivotal Clinical Trial
Tracheobronchomalacia
Enrolling by invitation
Primary Posterior Tracheopexy Prevents Tracheal Collapse
Oesophageal Atresia With Tracheo-Oesophageal Fistula, Tracheomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles P Pugh, MD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheobronchomalacia, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles P Pugh, MD (9013352402, cpugh2@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299008, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.