Overview

This trial is active, not recruiting.

Condition pierre robin syndrome
Treatment pre-epiglottic baton plate (pebp)
Sponsor University Hospital Tuebingen
Collaborator German Federal Ministry of Education and Research
Start date January 2013
End date August 2016
Trial size 50 participants
Trial identifier NCT02266043, FACE-Subproject SP5-Tuebingen

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change in mixed-obstructive apnea index (MOAI)
time frame: upon admission within the first year of life (before start of treatment) and 3 months after hospital discharge

Secondary Outcomes

Measure
Change in standard deviation score for body weight
time frame: upon admission within the first year of life (before start of treatment) and 3 months after hospital discharge
Duration of hospital stay
time frame: admission within the first year of life for initiation of study intervention
Treatment failure
time frame: 3 months after admission for initiation of study intervention

Eligibility Criteria

Male or female participants up to 12 months old.

Inclusion Criteria: - Infants < 1 year at admission, Pierre-Robin-like phenotype Exclusion Criteria: - no parental consent; need for immediate tracheotomy

Additional Information

Official title Cohort Study on Prevalence and Early Treatment Outcomes in Pierre-Robin-Like Phenotype
Principal investigator Christian F Poets, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.