Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Withdrawn before enrolling

Conditions studied: Pierre Robin Sequence

In brief

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.

Key facts

Study ID

NCT02432638

Run by

NYU Langone Health

People needed

0

Starts

2015-04-01

Expected to finish

2017-10-27

Last updated by the study team

2017-11-22

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent/Assent Form
• 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.

You may not qualify if…

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

Where it is running

• NYU School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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