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Compromised airway in children with congenital mandibular hypoplasia

Recruiting
Conditions
Mandibular hypoplasia / short lower jaw
10027664
Registration Number
NL-OMON45263
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

Mandibular hypoplasia and symptoms of respiratory distress
Age below 17 years

Exclusion Criteria

No informed consent
Patient or parent(s) or guardian(s) do not speak Dutch

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>A standardised questionnaire combined with clinical examination and<br /><br>ENT-examination (The Sleep Clinical Record) will be used to assess the clinical<br /><br>signs of possible respiratory problems. Respiratory problems are assessed with<br /><br>a polysomnography. The outcome measurements of the polysomnography will be<br /><br>described by the Obstructive Apnea Hypopnea Index (OAHI) and the Oxygen<br /><br>Desaturation Index (ODI). An OAHI of 1-4 events/hour (mild), OAHI of 5-10<br /><br>(moderate) and an OAHI of > 10 (severe) will be used to describe the severity<br /><br>of sleep-disordered breathing (SDB). </p><br>
Secondary Outcome Measures
NameTimeMethod
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