NCT02266043

Early Treatment Outcomes in Pierre-Robin-Like Phenotype

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pierre Robin Syndrome

Interventions

Type	Name	Description
DEVICE	Pre-epiglottic baton plate (PEBP)	modified acrylic palatal plate in which a velar extension resembling a spur or baton shifts the base of the tongue forward. This treatment is the standard care for infants with Pierre-Robin-Like Phenotype in the participating study centers and not assigned by protocol.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-08-31
• Completion: 2016-12-31
• First posted: 2014-10-16
• Last updated: 2018-05-11

Locations

3 sites across 1 country: Germany