Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 1
Healthy Volunteers: t
View:

• laryngomalacia

• stridor

• breathing difficulties

Locations
Other Locations
Norway
Lovisenberg Diaconal Hospital
RECRUITING
Oslo
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Harriet Akre
harriet.akre@medisin.uio.no
+4723070000
Backup
Britt Øverland
brov@lds.no
+4723225000
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 50
Treatments
Children with laryngomalacia
Healthy children
Sponsors
Collaborators: University of Oslo, Lovisenberg Diakonale Hospital
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.