Early Treatment Outcomes in Pierre-Robin-Like Phenotype
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|ClinicalTrials.gov Identifier: NCT02266043|
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment|
|Pierre Robin Syndrome||Device: Pre-epiglottic baton plate (PEBP)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Cohort Study on Prevalence and Early Treatment Outcomes in Pierre-Robin-Like Phenotype|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||August 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
- 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.
- 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 ]Change in mixed-obstructive apnea index (MOAI) assessed by polygraphy from pre- to post-intervention as a marker of Pierre-Robin-sequence-related breathing disorder
- 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 ]Body weight will be obtained by electronic scales and the standard deviation score for weight calculated
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266043
|Centre of Competence for Oro- and Craniofacial Malformations and Department of Neonatology, Univ. Hospital of Cologne|
|Cologne, Germany, 50924|
|Dept. of Neonatology and Interdisciplinary Centre for Craniofacial Malformations, University Hospital Tuebingen|
|Tuebingen, Germany, 72076|
|Dept. of Orthodontics and University Children's Hospital, University Hospital of Wuerzburg|
|Würzburg, Germany, 97080|
|Principal Investigator:||Christian F Poets, MD||Dept. of Neonatology and Interdisciplinary Centre forCraniofacial Malformations, University Hospital Tuebingen|
|Principal Investigator:||Siegmar Reinert, MD, PhD||Dept. of Craniofacial Surgery, University Hospital Tuebingen|