WithdrawnNot Applicable

Pierre Robin Sequence Outcome Assessment Multi Institutional Study

Stopped: PI left institution prior to enrollment of subjects

United States0Started 2015-04

Plain-language 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.

Who can participate

Age range1 Day – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Development of Functionality over time

Timeframe: Q 6 years

Trial details

NCT IDNCT02432638

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-10-27

View on ClinicalTrials.gov More Pierre Robin Sequence trials