Clinical Trial: Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)

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 Summary:

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.


Sponsor: New York University School of Medicine

Current Primary Outcome: Development of Functionality over time [ Time Frame: Q 6 years ]

We will monitor changes in maxillofacial development, functionality and surgical complications


Original Primary Outcome: Same as current

Current Secondary Outcome: Cleft Palate Repair outcome [ Time Frame: 1 year ]

Incidence of airway complications, Incidence of fistula and fistula location


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: April 10, 2015
Date Started: April 2015
Date Completion: November 2018
Last Updated: November 30, 2016
Last Verified: November 2016