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Early Treatment Outcomes in Pierre-Robin-Like Phenotype

NCT02266043 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-05-11

No results posted yet for this study

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.

Conditions

  • Pierre Robin Syndrome

Interventions

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.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christian F Poets, MD · Dept. of Neonatology and Interdisciplinary Centre forCraniofacial Malformations, University Hospital Tuebingen

  • Siegmar Reinert, MD, PhD · Dept. of Craniofacial Surgery, University Hospital Tuebingen

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266043 on ClinicalTrials.gov