Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period

NCT05636410 | Completed DMC

• 1 other identifier: LARYNXUS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Diseases of the larynx and trachea are a heterogenous group of disorders. Witch may include congenital anatomical disorders, neoplastic changes, vocal cord paralysis of varied aetiology or narrowing of the larynx associated with long-term intubation. The multitude of disorders of these organs necessitates the continuing search for diagnostic methods which will not only provide answers to clinical questions but will also be safe and with the least level of interference with the wellbeing of the patient, which is of particular importance in the neonate. In recent decades only a few studies have been reported which described the ultrasound anatomy of the larynx prior to and following intubation or that of the mobility of the vocal cords. To date, no standards have been published concerning the size of the structures of the larynx and trachea or the mobility of the vocal cords on ultrasound examination in the neonate. Additionally, there are no recommendations which include ultrasound examination as a reliable component of the diagnosis of congenital disorders of the larynx or other diseases of this organ. Ultrasound is a non-invasive, repeatable and safe diagnostic method, which has recently, thanks the development of technology, provided for the very accurate imaging of even small structures, as well as their assessment on dynamic examination. Furthermore, the easy availability of this examination may in the future contribute to the early diagnosis of diseases of the larynx and trachea without the need to prolong neonatal hospitalization or anaesthesia. In addition, the use of neural networks to analyse the ultrasound images obtained will provide for the development of algorithms which could become an irreplaceable tool, not only in the diagnosis of the disorders described, but also in predicating disorders affecting their further development or functional disorders in infancy.

Conditions

Larynx; Trachea

Keywords

larynx; trachea; newborn; ultrasound; anatomy

Outcome Measures

Primary Outcomes (3)

• Larynx and trachea anatomy description.

  The aim of the study is the accurate description of the ultrasound anatomy of the larynx and trachea and establishment of reference ranges for the size of individual structures of the larynx and trachea in the neonatal population.

  Through study completion, an average of 2 years

• Ultrasound assessment of the mobility of the vocal cords

  The study also aims to develop a universal method of ultrasound assessment of the mobility of the vocal cords on dynamic examination and to determine a rule for predicting the expected size of the laryngeal and tracheal structures in relation to anthropometric measurements.

  Through study completion, an average of 2 years

• Artificial intelligence algorithms based on artificial neural networks

  The study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.

  Through study completion, an average of 2 years

Interventions

Larynx and trachea ultrasound DIAGNOSTIC_TEST

After meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We plan to recruit all consecutive infants borned at 32 and 42 weeks of gestation.

You may qualify if:

• \- gestational age ≥32 weeks

You may not qualify if:

• gestational age \< 32 weeks,
• presence of significant congenital anomalies,
• intubated neonate,
• unstable neonate.

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead

Study Sites (2)

Department of Neonatology, Ujastek Medical Center

Krakow, Lesser Poland Voivodeship, 31-752, Poland

Location

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

Location

Related Publications (7)

• Ongkasuwan J, Ocampo E, Tran B. Laryngeal ultrasound and vocal fold movement in the pediatric cardiovascular intensive care unit. Laryngoscope. 2017 Jan;127(1):167-172. doi: 10.1002/lary.26051. Epub 2016 Apr 23.

  PMID: 27107409 BACKGROUND

• Beale T, Twigg VM, Horta M, Morley S. High-Resolution Laryngeal US: Imaging Technique, Normal Anatomy, and Spectrum of Disease. Radiographics. 2020 May-Jun;40(3):775-790. doi: 10.1148/rg.2020190160.

  PMID: 32364882 BACKGROUND

• Singh S, Jindal P, Ramakrishnan P, Raghuvanshi S. Prediction of endotracheal tube size in children by predicting subglottic diameter using ultrasonographic measurement versus traditional formulas. Saudi J Anaesth. 2019 Apr-Jun;13(2):93-99. doi: 10.4103/sja.SJA_390_18.

  PMID: 31007653 BACKGROUND

• Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.

  PMID: 8594834 BACKGROUND

• Paprocki LP, Migda B, Bokiniec R. Ultrasound assessment of larynx and trachea in the neonatal period - analysis of correlations and percentile charts. J Ultrason. 2025 Dec 31;25(103):20250034. doi: 10.15557/jou.2025.0034. eCollection 2025 Oct.

  PMID: 41555932 DERIVED

• Paprocki L, Migda B, Bokiniec R. Ultrasound assessment of larynx and trachea in the neonatal period-reference values. Eur Radiol. 2026 Jan;36(1):423-432. doi: 10.1007/s00330-025-11794-9. Epub 2025 Jul 10.

  PMID: 40634702 DERIVED

• Paprocki L, Migda B, Bokiniec R. Ultrasound Assessment of Larynx and Trachea in the Neonatal Period, Examination Standard with Predictive Values-Study Protocol. Diagnostics (Basel). 2023 Apr 28;13(9):1578. doi: 10.3390/diagnostics13091578.

  PMID: 37174969 DERIVED

MeSH Terms

Conditions

Laryngeal Diseases; Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Renata Bokiniec, M. D

  Dr hab. n. med.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: December 5, 2022
• Study Start: June 14, 2022
• Primary Completion: May 28, 2023
• Study Completion: July 31, 2023
• Last Updated: August 14, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2022 - December 2022
• Access Criteria: Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

Locations

PL (2)