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 afwijkingen
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 CT-scans:
- 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
succesful 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.
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 invasive 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
- Psychological burden of the stay at the ICU (in study population Ia and
control population Ia)
- The small risk for adverse events
(- Nasoendoscopy will only be done during palatal closure (under anaesthesia).
Serious adverse events related to the study are not expected.
All unexpected (serious) adverse events reported by the patient or observed by
the investigator or her staff will be recorded and reported to the appropriate
authority and to the staff.
The benefit of this project is the early recognition of an obstructive sleep
apnea (OSA) syndrome and its early treatment, thereby possibly preventing
negative long-term effects of OSA. Furthermore feeding and growth will be
closely monitored giving the opportunity for early intervention if necessary.
The main aim of the study is to establish the relation between airway
obstruction and mandibular hypoplasia, and to measure mandibular growth.
Mandibular hypoplasia is a congenital condition and can cause airway
obstruction which often manifests in the neonatal period. It is therefore
necessary to study this condition and its associated morbidity from an early
age in this specific group. Because growth of the mandible can influence the
airway obstruction we should investigate this at an early age as well.
's Gravendijkwal 230 (kamer D 2.16)
Rotterdam 3015 CE
NL
's Gravendijkwal 230 (kamer D 2.16)
Rotterdam 3015 CE
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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40418.078.12 |