LarynxNCT05636410
Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period
An observational study of Larynx and Trachea, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- What is being tested?
- Larynx and trachea ultrasound
- How many people
- 300 participants
- Where
- 2 sitesPoland
- Study dates
- 14 Jun 2022to 31 Jul 2023
- How long will I take part?
- 1 Day
- 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 0 to 28 days
- All sexes
- Child
Study population: We plan to recruit all consecutive infants borned at 32 and 42 weeks of gestation.
Who may be able to join
- gestational age ≥32 weeks
Who cannot join
- gestational age < 32 weeks,
- presence of significant congenital anomalies,
- intubated neonate,
- unstable neonate.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Neonatology, Ujastek Medical Center
Krakow, Lesser Poland Voivodeship, 31-752
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
About this study
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.
Read more
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.
Read the detailed description
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.
Diagnosis of diseases of the larynx and trachea in the neonate and infant is mainly based on endoscopy, magnetic resonance imaging and computer tomography. These investigations are invasive and not infrequently require anaesthetising the patient.
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. These studies involved small groups of subjects and were performed using lower quality ultrasound devices which did not provide for unequivocal conclusions to be drawn. 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.
The aim of the study is the accurate description of the ultrasound anatomy of the larynx and trachea and to establish reference ranges for the size of individual structures of the larynx and trachea in the neonatal population.
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.
Furthermore, the aim of the study is to promote the use of a non-invasive examination, such as ultrasonography, in the diagnosis of diseases of the larynx and trachea in the youngest patients.
Additionally, the study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.
- Being tested
- Larynx and trachea ultrasound
- Keywords
- larynx, trachea, newborn, ultrasound, anatomy
- Medical subject headings
- Laryngeal Diseases, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Larynx and trachea ultrasoundDiagnostic test
After meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start14 Jun 2022
- Primary completion28 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LarynxStudies 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
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata Bokiniec, M. D, Study chair, Dr hab. n. med.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636410
- Sponsor's protocol ID
- LARYNXUS
- Status last verified
- May 2023
- First submitted
- 13 Jun 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available, after deidentication. The study protocol will also be available.
Publications
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.
PubMed 27107409Beale 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.
PubMed 32364882Singh 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.
PubMed 31007653Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
PubMed 8594834Paprocki 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.
PubMed 41555932Paprocki 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.
PubMed 40634702Paprocki 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.
PubMed 37174969
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of the Larynx and Trachea in the Neonatal Period
- ClinicalTrials.gov ID
- NCT05636410
- Acronym / sponsor ID
- LARYNXUS
- Keywords
- larynx, trachea, newborn, ultrasound, anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Dec 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.
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.
Detailed description
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.
Diagnosis of diseases of the larynx and trachea in the neonate and infant is mainly based on endoscopy, magnetic resonance imaging and computer tomography. These investigations are invasive and not infrequently require anaesthetising the patient.
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. These studies involved small groups of subjects and were performed using lower quality ultrasound devices which did not provide for unequivocal conclusions to be drawn. 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.
The aim of the study is the accurate description of the ultrasound anatomy of the larynx and trachea and to establish reference ranges for the size of individual structures of the larynx and trachea in the neonatal population.
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.
Furthermore, the aim of the study is to promote the use of a non-invasive examination, such as ultrasonography, in the diagnosis of diseases of the larynx and trachea in the youngest patients.
Additionally, the study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- We plan to recruit all consecutive infants borned at 32 and 42 weeks of gestation.
Key inclusion criteria (1 listed)
- gestational age ≥32 weeks
Key exclusion criteria (4 listed)
- gestational age < 32 weeks,
- presence of significant congenital anomalies,
- intubated neonate,
- unstable neonate.
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 |
|---|---|---|
| Larynx and trachea ultrasoundAfter meeting enrolment criteria the larynx and trachea ultrasound will be performed at 32 and 42 weeks of gestation. | Diagnostic test | – |
Primary outcome
Larynx and trachea anatomy description.
Time frame: Through study completion, an average of 2 years
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.
Ultrasound assessment of the mobility of the vocal cords
Time frame: Through study completion, an average of 2 years
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.
Artificial intelligence algorithms based on artificial neural networks
Time frame: Through study completion, an average of 2 years
The study will be conducted in order to develop artificial intelligence algorithms based on artificial neural networks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 27107409Ongkasuwan 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.
- Background: PubMed 32364882Beale 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.
- Background: PubMed 31007653Singh 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.
- Background: PubMed 8594834Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- Derived from this study: PubMed 41555932Paprocki 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.
- Derived from this study: PubMed 40634702Paprocki 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.
- Derived from this study: PubMed 37174969Paprocki 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available, after deidentication. The study protocol will also be available.
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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.
Renata Bokiniec, M. D study chair
Dr hab. n. med.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Larynx and Trachea, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
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 4 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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Larynx and trachea anatomy description. (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. 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 NCT05636410, which also lists 7 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 14 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.