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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
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment
Pierre Robin Syndrome Device: Pre-epiglottic baton plate (PEBP)

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Duration of hospital stay [ Time Frame: admission within the first year of life for initiation of study intervention ]
  3. Treatment failure [ Time Frame: 3 months after admission for initiation of study intervention ]


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants <1 year admitted with Pierre-Robin-like phenotype to participating centres
Criteria

Inclusion Criteria:

  • Infants < 1 year at admission, Pierre-Robin-like phenotype

Exclusion Criteria:

  • no parental consent; need for immediate tracheotomy

Information from the National Library of Medicine

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


Locations
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Germany
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
Sponsors and Collaborators
University Hospital Tuebingen
German Federal Ministry of Education and Research
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02266043     History of Changes
Other Study ID Numbers: FACE-Subproject SP5-Tuebingen
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by University Hospital Tuebingen:
Upper airway obstruction

Additional relevant MeSH terms:
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Pierre Robin Syndrome
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities