Study Results
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Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2022-08-11
2024-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Bethanechol
Infants whom will be treated with bethanechol for tracheobronchomalacia in level IV center Neonatal Intensive Care Unit.
Interventions
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Bethanechol
Infants whom will be treated with bethanechol for tracheobronchomalacia in level IV center Neonatal Intensive Care Unit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with fixed tracheomalacia or bronchomalacia due to external compression of airways.
ALL
No
Sponsors
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Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Charles Preston Pugh
Neonatology Fellow
Principal Investigators
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Charles P Pugh, MD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Hospital Research Institute
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Downing 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.
Gunatilaka 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.
Wagner 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.
Bass 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.
Panitch 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.
Hysinger 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.
Madan 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.
Nealon 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.
Lee 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.
Bergeron 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.
Masters 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.
Wallis 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.
DeBoer 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.
Su YT, Chiu CC, Lai SH, Hsia SH, Lin JJ, Chan OW, Chiu CY, Tseng PL, Lee EP. Risk Factors for Tracheobronchomalacia in Preterm Infants With Bronchopulmonary Dysplasia. Front Pediatr. 2021 Jun 25;9:697470. doi: 10.3389/fped.2021.697470. eCollection 2021.
Other Identifiers
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274192
Identifier Type: -
Identifier Source: org_study_id
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