Trial record 1 of 2 for:    "Pierre-Robin sequence"
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Functional Modeling of the Pediatric Airway

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie D Davis, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT01690078
First received: July 30, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition
Subglottic Stenosis (SGS)
Pierre Robin Sequence (PRS)
Micrognathia.
Normal Controls From CT Scans of the Upper Airway.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Modeling for Treatment of Upper Airway Obstruction in Young Children

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Functional computational model outcome parameters [ Time Frame: years 1- 3 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Validation of Computational model [ Time Frame: year 4 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  1. 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
  2. Informed consent by parent or legal guardian
  3. Age < 18 years at enrollment
  4. Scheduled for clinically indicated endoscopic upper airway evaluation
  5. 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.

Exclusion Criteria:

  1. Acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week.
  2. 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).
  3. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690078

Locations
United States, North Carolina
North Carolina Children's Hospital
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Stephanie D Davis, MD Indiana University School of Medicine
Principal Investigator: Carlton Zdanski, MD University of North Carolina, Chapel Hill
Principal Investigator: Richard Superfine, PhD University of North Carolina, Chapel Hill
  More Information

Publications:
Yi Hong1, Sarang Joshi3, Mar Sanchez4, Martin Styner1,and Marc Niethammer. Metamorphic Geodesic Regression. Accepted to the 15h International Conference on Medical Image Computing andComputer Assisted Intervention. 2012.

Responsible Party: Stephanie D Davis, MD, Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT01690078     History of Changes
Other Study ID Numbers: 10-1634, RO1HL105241
Study First Received: July 30, 2012
Last Updated: June 10, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of North Carolina, Chapel Hill:
Airway modeling
Pierre Robin Sequence or PRS
Micrognathia
Subglottic Stenosis or SGS

Additional relevant MeSH terms:
Pierre Robin Syndrome
Laryngostenosis
Micrognathism
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory System Abnormalities
Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014