Aim of total study:Diagnosing all components of RS in an objective mannerAim of present substudy:Increasing the reliability and decreasing the burden of the method with which glossoptosis can be determined in newborns with RS
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Feasibility Cine MRI
2. Accuracy of Cine MRI in showing upper airway obstruction/glossoptosis
Secondary outcome
not applicable
Background summary
Robin Sequence (RS) is an infrequent condition characterized by micrognathia
and respiratory insufficiency, with or without cleft palate. RS is clinically
characterized by varying degrees of upper airway obstruction, which is often
caused by glossoptosis, leading to respiratory insufficiency and feeding
difficulties. Many researchers therefore add glossoptosis as essential
component of RS.
In literature no consensus exists regarding the criteria to define RS. Studies
describing the various management strategies use different definitions,
severely impairing meta-analysis. Further etiological studies or management
trials can only be performed if a single, strict definition with objective
criteria for RS is available. Micrognathia can be studied using 3D facial
scanning, and respiratory problems through polysomnographies. For glossoptosis
no such relatively simple diagnostic tool is available. We hypothesize that
Cine MRI will be a useful method in objectifying glossoptosis, and be more
patient friendly than the currently used gold standard, flexible fiberoptic
laryngoscopic visualization by the ENT surgeon.
Study objective
Aim of total study:
Diagnosing all components of RS in an objective manner
Aim of present substudy:
Increasing the reliability and decreasing the burden of the method with which
glossoptosis can be determined in newborns with RS
Study design
Observational study with noninvasive measurements.
Study burden and risks
The risk of Cine MRI is limited. No anesthesia will be needed by using the
*Feed and wrap* method. There is no benefit for the participants (patients;
control group) to the study. There may be a group benefit for patients who will
be diagnosed with RS in the future as the diagnosis may be confirmed more
easily. Having a strict definition with objective measurements will be
essential for research and optimal treatment. For the control group the burden
will be very limited since the scanning time will increase 3-5 min compared to
the time for their brain MRI for patient care.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patient group:
• Subjective diagnosis of Robin Sequence:
• Micrognathia, diagnosed by the responsible physician
• Upper airway obstruction diagnosed with polysomnography
• With or without cleft palate
• Informed consent by parents / caregivers;Control group:
• Neonate of 0-2weeks undergoing a brain MRI for patient care purposes
• No known congenital anomalies
• Informed consent signed
Exclusion criteria
Patients/controls and their parents unable to read and understand the written information
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 | NL49007.018.14 |