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Airway obstruction in children with congenital hypoplasia of the mandible.


- candidate number11112
- NTR NumberNTR3307
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-feb-2012
- Secondary IDsNL37895.078.12 CCMO
- Public TitleAirway obstruction in children with congenital hypoplasia of the mandible.
- Scientific TitleAirway obstruction in children with congenital hypoplasia of the mandible.
- ACRONYMCMH
- hypothesisChildren with congenital mandibular hypoplasia are at risk for development of airway obstruction.
- Healt Condition(s) or Problem(s) studiedCongenital mandibular hypoplasia
- Inclusion criteriaStudy 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 criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-okt-2012
- planned closingdate15-okt-2016
- Target number of participants525
- InterventionsThis 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 / 2b. The test and exams are:
1. Polysomnography (for the detecting of OSA, two clinical PSG's in the first year, and thereafter an ambulant PSG once a year);
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 patient care) will get an ultrasound exam of the mandible.
- Primary outcomeOutcomes 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.
- Secondary outcomeN/A
- TimepointsExams in both study population 1a / control population 1 b / control population 2 will take place at the age of 3 months, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 6 years old.

Exams in study population 1b / control population 1b are cross-sectional and will consist of one study visit.

Exams in study population 2 are cross-sectional and will take place directly after the 3D-CT scan.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Manouk Lieshout, van
- CONTACT for SCIENTIFIC QUERIESDrs. Manouk Lieshout, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryThe aim of this study is to establish the relation between congenital mandibular hypoplasia and upper airway obstruction using a prospective cohort and cross-sectional study design. Furthermore, we aim to analyse the craniofacial growth pattern, feeding problems and mandibular distraction outcome in children with congenital mandibular hypoplasia. Also we will determine the reliablity of ultrasonography compared to 3D-CT scans in measurement of the mandible.
- Main changes (audit trail)
- RECORD10-feb-2012 - 6-okt-2012


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