Primary objectives:1a. To determine the severity and course of obstructive sleep apnea in children with congenital mandibular hypoplasia (both isolated and syndromal).1b. To determine the growth pattern of the lower face in relation to the upper…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Craniofaciale aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes of physical examination:
- length in centimetres
- head circumference in millimetres
- weight in kilograms
Outcomes of polysomnography:
- Apnea Hypopnea Index (AHI)
- Oxygen Desaturation Index (ODI)
Outcomes of ENT exam and nasoendoscopy:
- Malampatti score
- Cormack-Lehane score
- Sher-classification
Outcomes of measurements on :
- distances in millimetres
Secondary outcome
N/A
Background summary
A common problem in children with a craniofacial anomaly is an upper airway
obstruction. This obstruction may be seen at the level of the lower face and/or
the level of the midface. Early recognition of symptoms and prompt effective
treatment by a specialised craniofacial team are important aspects for
successful care in these children. This study will focus on airway obstruction
at the level of the lower face in children with congenital mandibular
hypoplasia (both isolated and syndromal).
Study objective
Primary objectives:
1a. To determine the severity and course of obstructive sleep apnea in children
with congenital mandibular hypoplasia (both isolated and syndromal).
1b. To determine the growth pattern of the lower face in relation to the upper
airway in children with congenital mandibular hypoplasia.
Secondary objectives;
2a. To evaluate prevalence, characteristics and management of feeding
difficulties.
2b. To assess the long-term outcome and complications of mandibular distraction
surgery.
2c. To assess the reliability and validity of ultrasonographic imaging for
cephalometric measurements on the mandible.
Study design
Observational study, both prospective cohort study and cross-sectional.
Study burden and risks
Disadvantages of participation in this study are the extra time necessary for
the study visit(s), the extra time necessary to fill out the questionnaires and
the small risk for adverse events. the nasoendoscopy could be related to
adverse events. the lateral and posterior-anterior-X-ray both give radiation
exposure (0.005 mSv). This is about the same amount of background radiation we
are exposed in our daily life (0.0065 mSv). Serious adverse events related to
the study are not expected. All unexpected adverse events reported
spontaneously by the patient or observed by the investigator or her staff will
be recorded and reported to the appropriate authority.
's-Gravendijkwal
3015CE
NL
's-Gravendijkwal
3015CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37895.078.12 |
| OMON | NL-OMON26550 |