Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06464757 |
| Other study ID # |
646948 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 31, 2034 |
Study information
| Verified date |
June 2024 |
| Source |
Oslo University Hospital |
| Contact |
Harriet Akre |
| Phone |
+4723070000 |
| Email |
harriet.akre[@]medisin.uio.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Laryngomalacia is the most frequent cause of stridor in children under 1 year. The airway
obstruction generates turbulent airway flow and creates the characteristic high-frequency
stridor sound. In addition, the airway obstruction can cause apnea, a following drop in
oxygen saturation and sleep disturbances. The symptoms of laryngomalacia are often worsened
by activity, feeding, crying and lying flat on the back. The diagnosis is made with flexible
laryngoscopy when the child is awake. The children are most often treated with expectation,
information and guidance, observation with help with feeding and reflux treatment. Up to 20%
of patients have a severe degree of laryngomalacia with apneas, which is an indication for
surgical treatment. The investigators want to examine whether sleep examinations can help us
deciding which child benefit from surgery, and follow-up the child again after 4-6 weeks and
1 year. The sleep examinations are carried out with polygraphy and/or polysomnography with
simultaneous audio records and video monitoring and with Somnofy from VitalThings. The
investigators want to use artificial intelligence and machine learning when analyzing the
sleep examinations. The investigators also want to have a control group examining the sleep
and breathing during night at home. In both groups the investigators want to examine the
quality of life with the questionnaire ITQoL-SF47.
Description:
Breathing difficulties in young children are a common cause of contact in the health care
system, and are often related to harmless infection-triggered conditions in the upper and
lower respiratory tract. In the vast majority of the cases, the condition is self-limiting
and the child can be treated in primary care. In more serious or long-term cases, the child
is referred to the specialist health care, most often to pediatricians, where the focus is
naturally directed to pulmonary medical causes such as asthma, allergies and infections, as
these make up the majority of breathing difficulties in children. Less common and less
well-known are breathing difficulties in young children caused by airway obstructions in the
upper airways, which might cause a characteristic respiratory distress called stridor.
Stridor occurs as a result of turbulent airflow through a relatively narrower part of the
upper airways, such as the larynx and trachea, and produces a high-frequency whistling sound
during inspiration. Causes of stridor can be congenital or acquired, and stridor can often be
confused with asthma. It is appropriate to refer to an ENT doctor for a thorough anatomical
examination of the upper respiratory tract in these affected children to identify the cause
of stridor and to be able to provide the correct treatment.
Laryngomalacia is the most frequent cause of stridor in children under 1 year of age, and is
a congenital condition where the tissue at the top of the larynx collapses over the airway
opening to the larynx and therefore creates an upper airway obstruction during inspiration.
In severe cases, laryngomalacia can be curatively treated with surgery.
For long time the ENT departments and pediatric departments at regional hospitals in Norway
have been responsible for the treatment of children under 1 year of age with laryngomalacia.
However, experience in children under 1 year with laryngomalacia is limited, and there is a
lack of systematic mapping and follow-up of these children. In Health South-East in Norway,
with approximately 3.1 million inhabitants, children with a severe degree of stridor will be
referred to the ENT department and/or the pediatric department at Oslo University Hospital.
In addition, Oslo University Hospital also receives children with stridor from other health
regions in Norway. Therefore, the patient base is well suited for a systematic mapping and
follow-up. In this research project, the investigators want to carry out a mapping and
follow-up of children with laryngomalacia, investigate how affected these children are by
their breathing difficulties and the impact it has on sleep and quality of life on the child
and the family. The investigators also want to investigate whether the treatment improves
these variables.
In addition, the investigators want to recruit a control group of healthy children under 1
year of age to examine sleep and mapping the quality of life of the child and family. These
children will be recruited from health centers, and the investigators want to follow them for
up to 1 year.
In both groups the investigators want to use artificial intelligence and machine learning
when analyzing the sleep examinations.
