Early Treatment Outcomes in Pierre-Robin-Like Phenotype

Pierre Robin Syndrome Clinical Trial

Official title: Cohort Study on Prevalence and Early Treatment Outcomes in Pierre-Robin-Like Phenotype

Status Completed

Clinical Trial Summary

In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton plate, the main treatment approach currently used in Germany for Pierre-Robin-Like phenotype, on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive apnea index assessed by polysomnography, standard deviation score for body weight) upon admission and 3 months after hospital discharge.

Clinical Trial Description

Pierre-Robin sequence consists of a small lower jaw, a retropositioned tongue (glossoptosis), and optionally cleft palate, leading to severe upper airway obstruction and failure to thrive; occasionally even to sudden infant death. Treatment approaches are heterogeneous, some are considerably invasive; few have been evaluated by objective tests.

In a longitudinal cohort study, we want to assess the effect of the pre-epiglottic baton plate on upper airway obstruction and failure to thrive using objective criteria (mixed-obstructive apnea index assessed by polysomnography, standard deviation score for body weight) upon admission and 3 months after hospital discharge. The pre-epiglottic baton plate is the main treatment approach currently used in Germany for this condition and practised standard care in the three participating study centers.

These data will help to compare the effect of the main treatment currently used in Germany with international data on more invasive treatments used in this rare condition. ;

Related Conditions & MeSH terms

• Pierre Robin Syndrome

• NCT number: NCT02266043
• Study type: Observational
• Source: University Hospital Tuebingen
• Status: Completed
• Start date: January 1, 2013
• Completion date: December 31, 2016