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Airway obstruction in children with congenital mandibular hypoplasia.

Recruiting
Conditions
Craniofaciale afwijkingen
small lower jaw
underdevelopment of the lower jaw
Registration Number
NL-OMON37722
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
313
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 congenital mandibular hypoplasia;Study Population 2:
- Below the age of 18 years
- 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
- Without congenital mandibular hypoplasia;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 not 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 CT-scans:<br /><br>- Distances in millimetres.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>N/A.</p><br>
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