Pierre Robin Sequence
Conditions
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.
Interventions
None listed
Sponsors
Indiana University
University of Texas
University of California, Los Angeles
University of Southern California
NYU Langone Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Functionality over time | Q 6 years | We will monitor changes in maxillofacial development, functionality and surgical complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cleft Palate Repair outcome | 1 year | Incidence of airway complications, Incidence of fistula and fistula location |
Other
| Measure | Time frame | Description |
|---|---|---|
| mandibular growth | 6 years | as measired by PE, panorex and lateral cephalogram |
| Long term outcome | 12 and 18 years | change in AHI or additional airway surgery, incidence of TMJ, tooth development, sensation, scar quality, limitation in jaw excursion |
Countries
United States
Outcome results
None listed