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Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)

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ClinicalTrials.gov Identifier: NCT02432638
Recruitment Status : Withdrawn (PI left institution prior to enrollment of subjects)
First Posted : May 4, 2015
Last Update Posted : November 22, 2017
Sponsor:
Collaborators:
Indiana University
University of Texas
University of California, Los Angeles
University of Southern California
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular distraction osteogenesis). This study aims to develop a scoring system to determine success and complication rate pre and post MDO.

Condition or disease
Pierre Robin Sequence

Detailed Description:

The recruitment phase of this trial is 3 years. Duration of the trial is 19 years.

All study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. There will be no experimental/treatment arms in this study. All patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. The purpose of this study is to follow multiple surgical outcomes following these standard of care practices. The methods and procedures detailed below follow published and accepted standards of care.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 19 Years
Official Title: Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)
Study Start Date : April 2015
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017





Primary Outcome Measures :
  1. Development of Functionality over time [ Time Frame: Q 6 years ]
    We will monitor changes in maxillofacial development, functionality and surgical complications


Secondary Outcome Measures :
  1. Cleft Palate Repair outcome [ Time Frame: 1 year ]
    Incidence of airway complications, Incidence of fistula and fistula location


Other Outcome Measures:
  1. mandibular growth [ Time Frame: 6 years ]
    as measired by PE, panorex and lateral cephalogram

  2. Long term outcome [ Time Frame: 12 and 18 years ]
    change in AHI or additional airway surgery, incidence of TMJ, tooth development, sensation, scar quality, limitation in jaw excursion



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include all infants under the age of 6 months who undergo mandibular distraction. We will include all racial and ethnic groups as well as both genders. We will not include patients over the age of 6 months.
Criteria

Inclusion Criteria:

  1. Signed Informed Consent/Assent Form
  2. All patients with PRS as defined by mandibular hypoplasia, glossoptosis causing airway obstruction, who undergo MDO prior to the age of 6 months, will be included in the study. This will include all infants regardless of syndromic diagnosis, other organ system abnormalities, cleft palate diagnosis or the presence of other concurrent craniofacial anomalies.

Exclusion Criteria:

  1. Infants over the age of 6 months
  2. patients who undergo mandibular distraction for conditions other than Pierre Robin sequence.
  3. Patient who refuse to be included in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432638


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10010
Sponsors and Collaborators
NYU Langone Health
Indiana University
University of Texas
University of California, Los Angeles
University of Southern California
Investigators
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Study Chair: Roberto Flores, MD NYU School of Medicine

Additional Information:

Publications:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02432638     History of Changes
Other Study ID Numbers: 14-01966
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
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Pierre Robin Syndrome
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities