Subglottic Stenosis (SGS)NCT01690078
Functional Modeling of the Pediatric Airway
An observational study of Subglottic Stenosis (SGS) and Pierre Robin Sequence (PRS), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an effective diagnostic and treatment planning tool. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Subglottic Stenosis (SGS), Pierre Robin Sequence (PRS), Micrognathia
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2015
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children < 18 years of age with a diagnosis of either Pierre Robin Sequence, Micrognathia or Subglottic Stenosis. Clinically indicated control data will be collected from CT scans of neck and maxillofacial CT scans performed on children < 18 years of age
Who may be able to join
- Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:
- micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or
- Diagnosis of SGS defined (Bluestone) as:
- subglottic airway diameter of 4 mm or less in a term neonate;
- subglottic airway diameter of 3.5 mm or less in a premature neonate;
- inability to pass an endotracheal tube of expected size for age
Show all 12Show fewer
- Informed consent by parent or legal guardian
- Age < 18 years at enrollment
- Scheduled for clinically indicated endoscopic upper airway evaluation
- Ability to comply with study visits and study procedures as judged by the site investigator
- Inclusion criterion also included for Specific Aim 2 (Longitudinal):
- Subjects must be scheduled for an operative procedure to correct or bypass upper airway obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty, cricotracheal resection, or tracheostomy) OR recently (within past 4 weeks) diagnosed as having an anomaly not currently requiring surgical management.
Who cannot join
- Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
- Physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status).
- For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.
- Control data will be collected from clinically indicated neck or maxillofacial CT imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Children's Hospital
Chapel Hill, North Carolina, 27514
About this study
Official title: Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children
The investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an effective diagnostic and treatment planning tool.
- Conditions
- Subglottic Stenosis (SGS), Pierre Robin Sequence (PRS), Micrognathia, Normal Controls From CT Scans of the Upper Airway
- Keywords
- Airway modeling, Pierre Robin Sequence or PRS, Micrognathia, Subglottic Stenosis or SGS
- Medical subject headings
- Pierre Robin Syndrome, Micrognathism, Prieto X-linked mental retardation syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross sectional | Cross sectional study where subjects with PRS, micrognathia, or SGS will have a single study visit that will be scheduled within 14 days of a clinically indicated upper airway endoscopy. CT scans of the neck or maxillofacial CT will be obtained in all subjects. During upper airway endoscopy, airway measurements will be conducted. Cohort may include subjects who have previously undergone medical or surgical intervention for their airway obstruction, or who are currently undergoing multidisciplinary team management. The following data will be collected: clinical parameters, Obstructive Sleep Apnea (OSA)OSA-18 (quality of life) questionnaire, and lung function tests (subjects > 4 years of age). Clinically indicated swallowing studies and voice evaluations will be collected. | |
| Longitudinal | The prospective, longitudinal cohort arm of the study is designed to describe the effects of treatment on clinical and computational model endpoints. This is performed in a subset of subjects with PRS, micrognathia, or SGS who are scheduled for clinically indicated upper airway endoscopy and who are scheduled to complete a definitive treatment course which necessitates multiple endoscopic evaluations and follow-up imaging. Subjects will have an entry visit comparable to the cross-sectional entry visit. Longitudinal subjects will have up to 3 additional study visits over a 12 to 15-month period. | |
| Normal Control Data | Normal de-identified control data is retrospectively collected from clinically indicated CT scans of the neck and maxillofacial CT scans in children less than 18 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional computational model outcome parameters
Change in functional computational modeling parameters as compared to the change in percent of total time spent with oxygen saturation < 90% as noted on polysomnogram (physiologic measure) and change in airway measurements obtained via clinically indicated upper airway endoscopy (anatomic measure) pre and post-intervention(medical or surgical)
Measured: years 1- 3
Secondary outcomes (1)
Validation of Computational model
Apply the computational model to infants and children being evaluated for Pierre Robin Sequence and Subglottic Stenosis, to determine the ability of the model to accurately predict the results of various potential interventions on anatomic and physiologic metrics.
Measured: year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Subglottic Stenosis (SGS)Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stephanie D Davis, MD, Principal investigator, Indiana UniversityCarlton Zdanski, MD, Principal investigator, University of North Carolina, Chapel HillRichard Superfine, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690078
- Sponsor's protocol ID
- 10-1634
- Other IDs
- R01HL105241
- Status last verified
- Jun 2016
- First submitted
- 30 Jul 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calloway HE, Kimbell JS, Davis SD, Retsch-Bogart GZ, Pitkin EA, Abode K, Superfine R, Zdanski CJ. Comparison of endoscopic versus 3D CT derived airway measurements. Laryngoscope. 2013 Sep;123(9):2136-41. doi: 10.1002/lary.23836.
PubMed 24167819Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. doi: 10.1016/j.jcp.2013.01.037.
PubMed 23729842Mitran (2012c), Predictive Modeling of Upper Airway Flow in Young Children, Proceedings, 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC'12), San Diego, CA, (accepted).
Mitran, S. (2012b), "Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows", Phys. Rev.E., (under review).
Alabi OS, Wu X, Harter JM, Phadke M, Pinto L, Petersen H, Bass S, Keifer M, Zhong S, Healey C, Taylor RM 2nd. Comparative Visualization of Ensembles Using Ensemble Surface Slicing. Proc SPIE Int Soc Opt Eng. 2012 Jan 22;8294:82940U. doi: 10.1117/12.908288.
PubMed 23560167Yi Hong, Yundi Shi, Martin Styner, Mar Sanchez, and Marc Niethammer. Simple Geodesic Regression for Image Time-Series. Accepted to the 5th Workshop on Biomedical Image Registration. 2012.
Hong Y, Joshi S, Sanchez M, Styner M, Niethammer M. Metamorphic geodesic regression. Med Image Comput Comput Assist Interv. 2012;15(Pt 3):197-205. doi: 10.1007/978-3-642-33454-2_25.
PubMed 23286131Zdanski, C., Kimbell, J.S., Superfine, R.S., and Davis, S. (2012). Computational Fluid Dynamics Modeling of the Pediatric Airway Utilizing Computed Tomography in Children with Pierre Robin Sequence. Poster presentation, European Society of Pediatric Otolaryngology, Amsterdam, The Netherlands, May 20-23, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children
- ClinicalTrials.gov ID
- NCT01690078
- Acronym / sponsor ID
- 10-1634
- Conditions
- Subglottic Stenosis (SGS), Pierre Robin Sequence (PRS), Micrognathia, Normal Controls From CT Scans of the Upper Airway
- Keywords
- Airway modeling, Pierre Robin Sequence or PRS, Micrognathia, Subglottic Stenosis or SGS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Sep 2012 (estimated)
- 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 investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with Pierre Robin Sequence (PRS) and laryngeal lesions (e.g. subglottic stenosis or SGS) can be used as an effective diagnostic and treatment planning tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cross sectional | – | –Cross sectional study where subjects with PRS, micrognathia, or SGS will have a single study visit that will be scheduled within 14 days of a clinically indicated upper airway endoscopy. CT scans of the neck or maxillofacial CT will be obtained in all subjects. During upper airway endoscopy, airway measurements will be conducted. Cohort may include subjects who have previously undergone medical or surgical intervention for their airway obstruction, or who are currently undergoing multidisciplinary team management. The following data will be collected: clinical parameters, Obstructive Sleep Apnea (OSA)OSA-18 (quality of life) questionnaire, and lung function tests (subjects > 4 years of age). Clinically indicated swallowing studies and voice evaluations will be collected. |
| Longitudinal | – | –The prospective, longitudinal cohort arm of the study is designed to describe the effects of treatment on clinical and computational model endpoints. This is performed in a subset of subjects with PRS, micrognathia, or SGS who are scheduled for clinically indicated upper airway endoscopy and who are scheduled to complete a definitive treatment course which necessitates multiple endoscopic evaluations and follow-up imaging. Subjects will have an entry visit comparable to the cross-sectional entry visit. Longitudinal subjects will have up to 3 additional study visits over a 12 to 15-month period. |
| Normal Control Data | – | –Normal de-identified control data is retrospectively collected from clinically indicated CT scans of the neck and maxillofacial CT scans in children less than 18 years of age. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children < 18 years of age with a diagnosis of either Pierre Robin Sequence, Micrognathia or Subglottic Stenosis. Clinically indicated control data will be collected from CT scans of neck and maxillofacial CT scans performed on children < 18 years of age
Key inclusion criteria (12 listed)
- Micrognathia, Suspected or Diagnosis of PRS, defined (Gorlin) as:
- micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or
- Informed consent by parent or legal guardian
- Age < 18 years at enrollment
- Scheduled for clinically indicated endoscopic upper airway evaluation
Key exclusion criteria (4 listed)
- Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
- Physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status).
- For research CT scans any sedation risk, such as Bronchopulmonary Dysplasia (BPD) with upper airway obstruction, residual oxygen requirement, and an unsecured airway.
- Control data will be collected from clinically indicated neck or maxillofacial CT imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Functional computational model outcome parameters
Time frame: years 1- 3
Change in functional computational modeling parameters as compared to the change in percent of total time spent with oxygen saturation < 90% as noted on polysomnogram (physiologic measure) and change in airway measurements obtained via clinically indicated upper airway endoscopy (anatomic measure) pre and post-intervention(medical or surgical)
1 secondary outcome
Validation of Computational model
Time frame: year 4
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 20 Apr 2017.
- Background: PubMed 24167819Calloway HE, Kimbell JS, Davis SD, Retsch-Bogart GZ, Pitkin EA, Abode K, Superfine R, Zdanski CJ. Comparison of endoscopic versus 3D CT derived airway measurements. Laryngoscope. 2013 Sep;123(9):2136-41. doi: 10.1002/lary.23836.
- Background: PubMed 23729842Mitran S. Continuum-kinetic-microscopic model of lung clearance due to core-annular fluid entrainment. J Comput Phys. 2013 Jul 1;244:193-211. doi: 10.1016/j.jcp.2013.01.037.
- BackgroundMitran (2012c), Predictive Modeling of Upper Airway Flow in Young Children, Proceedings, 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC'12), San Diego, CA, (accepted).
- BackgroundMitran, S. (2012b), "Lattice Fokker-Planck Method Based on Wasserstein Gradient Flows", Phys. Rev.E., (under review).
- Background: PubMed 23560167Alabi OS, Wu X, Harter JM, Phadke M, Pinto L, Petersen H, Bass S, Keifer M, Zhong S, Healey C, Taylor RM 2nd. Comparative Visualization of Ensembles Using Ensemble Surface Slicing. Proc SPIE Int Soc Opt Eng. 2012 Jan 22;8294:82940U. doi: 10.1117/12.908288.
- BackgroundYi Hong, Yundi Shi, Martin Styner, Mar Sanchez, and Marc Niethammer. Simple Geodesic Regression for Image Time-Series. Accepted to the 5th Workshop on Biomedical Image Registration. 2012.
- Background: PubMed 23286131Hong Y, Joshi S, Sanchez M, Styner M, Niethammer M. Metamorphic geodesic regression. Med Image Comput Comput Assist Interv. 2012;15(Pt 3):197-205. doi: 10.1007/978-3-642-33454-2_25.
- BackgroundZdanski, C., Kimbell, J.S., Superfine, R.S., and Davis, S. (2012). Computational Fluid Dynamics Modeling of the Pediatric Airway Utilizing Computed Tomography in Children with Pierre Robin Sequence. Poster presentation, European Society of Pediatric Otolaryngology, Amsterdam, The Netherlands, May 20-23, 2012.
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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.
Stephanie D Davis, MD principal investigator
Indiana University
Carlton Zdanski, MD principal investigator
University of North Carolina, Chapel Hill
Richard Superfine, PhD principal investigator
University of North Carolina, Chapel Hill
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 Subglottic Stenosis (SGS) and Pierre Robin Sequence (PRS), run by University of North Carolina, Chapel Hill 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 12 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 20 Apr 2017. 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?
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?
Change in Functional computational model outcome parameters (time frame: years 1- 3). 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 NCT01690078, which also lists 8 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 20 Apr 2017.