The Effect of Bethanechol on Tracheobronchomalacia

NCT05299008 | Unknown

• 1 other identifier: 274192
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

bethanechol; swing Edi; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 1 and then at 7-14 days

• Evaluating for change in regional impedance variation by use of Electrical Impedance Tomography

  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

  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.

  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.

  21 days

Study Arms (1)

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

Drug: Bethanechol

Interventions

Bethanechol DRUG

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

Also known as: bethanechol chloride

Infants with diagnosis of tracheobronchomalacia treated with bethanechol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatient infants in a level IV Neonatal Intensive Care Unit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 3440899 BACKGROUND

• 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.

  PMID: 7700760 BACKGROUND

• 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.

  PMID: 32579852 BACKGROUND

• 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.

  PMID: 9887142 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 2872649 BACKGROUND

• 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.

  PMID: 1980538 BACKGROUND

• 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.

  PMID: 30518799 BACKGROUND

• 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.

  PMID: 15805348 BACKGROUND

• 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.

  PMID: 31262530 BACKGROUND

• 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.

  PMID: 26178463 BACKGROUND

• 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.

  PMID: 28555179 BACKGROUND

• 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.

  PMID: 17989148 BACKGROUND

• 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.

  PMID: 31320455 BACKGROUND

• 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.

  PMID: 26816220 BACKGROUND

• 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.

  PMID: 34249821 BACKGROUND

MeSH Terms

Conditions

Tracheobronchomalacia

Interventions

Bethanechol

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bethanechol Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Officials

• Charles P Pugh, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles P Pugh, MD

CONTACT

9013352402; cpugh2@uams.edu

David Matlock, MD

CONTACT

3184589097; dmatlock@uams.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatology Fellow

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: August 11, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)