Airway obstruction in children with congenital hypoplasia of the mandible.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26550

Enrollment

525

Registered

2012-02-10

Start date

2012-10-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital mandibular hypoplasia

Interventions

This will be an invasive observational study in which patients in both study population 1a and control population 1a / 2 will undergo a number of exams and tests to address objectives 1a / 1b / 2a / 2

2. Endoscopy (to assess the type and severity of airway obstruction, in the first year)

3. Lateral skull X-ray (to assess the skull morphometrics, when the child is > 6 year on an annual basis)

4. Ultrasonography (to assess mandibular growth, annually)

5. Jaw-index (to assess mandibular growth, annually)

6. OSA-18/OSA-12 (to assess presence of OSA and QOL, annually). For the reliabity and validity study of ultrasonography all children in study population 2 (who undergo a 3D-CT scan as part of regular

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Outcomes of physical examination: 1. Length in centimetres; 2. Head circumference in millimetres; 3. Weight in kilograms. Outcomes of polysomnography: 1. Apnea Hypopnea Index (AHI); 2. Oxygen Desaturation Index (ODI). Outcomes of ENT exam and nasoendoscopy: 1. Malampatti score; 2. Cormack-Lehane score; 3. Sher-classification. Outcomes of measurements on: 1. Distances in millimetres.	—

Contacts

Public ContactManouk Lieshout, van

Eramus MC Dept. of Oral and Maxillofacial Surgery Dr. Molewaterplein 50 Room Ee 2.00a

m.vanlieshout@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)