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LaryngomalaciaNCT06464757

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

An observational study of Laryngomalacia and Sleep Apnea, Obstructive, run by Oslo University Hospital at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 1 week to 52 weeksHealthy volunteers can take part
How many people
50 participants
Where
2 sitesNorway
Study dates
1 Jan 2024to 31 Dec 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 week to 52 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children with laryngomalacia, stridor and/or breathing difficulties.

Who may be able to join

  • laryngomalacia
  • stridor
  • breathing difficulties

Who cannot join

  • none

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Britt Øverland contact

+4723225000

brov@lds.no

Norway2 sites, 2 recruiting
  • Oslo University Hospital

    Oslo, 0372

    Harriet Akre, +4723070000, harriet.akre@medisin.uio.no

    Recruiting
  • Lovisenberg Diaconal Hospital

    Oslo, 0456

    Britt Øverland, +4723225000

    Recruiting

Other trials in Norway

About this study

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.

Read the 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.

Medical subject headings
Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06464757
Study groupRoleWhat they receive
Children with laryngomalaciaNot described
Healthy childrenNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea-hypopnea-index

    Apnea-hypopnea-index

    Measured: 10 years

  2. Quality of life in toddlers

    Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2034 (estimated)
  4. Study completion31 Dec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464757
Sponsor's protocol ID
646948
Status last verified
Jun 2024
First submitted
21 May 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Laryngomalacia and Sleep Apnea, Obstructive, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harriet Akre (+4723070000, harriet.akre@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-hypopnea-index (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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