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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Sleep Apnea, Obstructive; Sleep Apnea; Surgery; Pediatric Disorder; Laryngomalacia; Ear, Nose and Throat Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Harriet Akre; Phone Number: +4723070000; Email: harriet.akre@medisin.uio.no
• Study Contact Backup: Name: Britt Øverland; Phone Number: +4723225000; Email: brov@lds.no

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Recruiting
    • Oslo University Hospital
    • Contact: Harriet Akre; Phone Number: +4723070000; Email: harriet.akre@medisin.uio.no
  • Oslo, Norway, 0456
    • Recruiting
    • Lovisenberg Diaconal Hospital
    • Contact: Britt Øverland; Phone Number: +4723225000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Children with laryngomalacia, stridor and/or breathing difficulties.

Description

Inclusion Criteria:

• laryngomalacia
• stridor
• breathing difficulties

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy children
Children with laryngomalacia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea-index	Apnea-hypopnea-index	10 years
Quality of life in toddlers	Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47)	10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Lovisenberg Diakonale Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Congenital Abnormalities; Musculoskeletal Diseases; Connective Tissue Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Musculoskeletal Abnormalities; Laryngeal Diseases; Cartilage Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Laryngomalacia
• Other Study ID Numbers: 646948

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No