Pierre Robin Sequence Clinical Trial
Official title:
Pierre Robin Sequence Outcome Assessment Multi Institutional Study (PROMIS)
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.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03423017 -
Brainstem Dysfunction Involvement in the Pathogenesis of Pierre Robin Sequence
|
N/A | |
| Completed |
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Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
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