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Airway obstruction in children with congenital hypoplasia of the mandible.

Withdrawn
Conditions
Craniofaciale aandoeningen
retrognathia
small lower jaw
Registration Number
NL-OMON37826
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
525
Inclusion Criteria

Study Population 1a:
- Age between 0 and 3 months
- Presence of a congenital mandibular hypoplasia;Study Population 1b:
- age between 3 months and 18 years old
- Presence of congenita mandibular hypoplasia;Study population 2:
- Below the age of 18 years old
- 3D CT-scan of the head as part of regular patient care;Control Population 1a:
- Age below 3 months
- Presence of cleft palate
- No congenital mandibular hypoplasia;Control population 1b:
- Age between 3 months and 18 years old
- Presence of cleft palate;Control Population 2:
- Age below 3 months
- Presence of an immature breathing pattern, but otherwise healthy

Exclusion Criteria

Control population 2:
- Congenital malformation
- Underlying condition that is known to influence growth

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Outcomes of physical examination:<br /><br>- length in centimetres<br /><br>- head circumference in millimetres<br /><br>- weight in kilograms<br /><br><br /><br>Outcomes of polysomnography:<br /><br>- Apnea Hypopnea Index (AHI)<br /><br>- Oxygen Desaturation Index (ODI)<br /><br><br /><br>Outcomes of ENT exam and nasoendoscopy:<br /><br>- Malampatti score<br /><br>- Cormack-Lehane score<br /><br>- Sher-classification<br /><br><br /><br>Outcomes of measurements on :<br /><br>- distances in millimetres</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>N/A</p><br>
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