Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Withdrawn

• Conditions: Pierre Robin Sequence

• Registration Number: NCT02432638
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of Functionality over time	Q 6 years	We will monitor changes in maxillofacial development, functionality and surgical complications

Secondary Outcome Measures

Name	Time	Method
Cleft Palate Repair outcome	1 year	Incidence of airway complications, Incidence of fistula and fistula location

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States