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Early Treatment Outcomes in Pierre-Robin-Like Phenotype

U

University Hospital Tuebingen

Status

Completed

Conditions

Pierre Robin Syndrome

Treatments

Device: Pre-epiglottic baton plate (PEBP)

Study type

Observational

Funder types

Other

Identifiers

NCT02266043
FACE-Subproject SP5-Tuebingen

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • no parental consent; need for immediate tracheotomy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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