Feeding problems and quality of life in children with a tracheostomy tube
Official title: Feeding Difficulties and Quality of Life in Children With Tracheal Cannula
Run by Karolinska Institutet · NCT06893458 · Data updated 2026-11-12
The team will see if feeding and swallowing problems are linked to how children with tracheostomy tubes and their parents rate the child's quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Solna, Stockholm County and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | March 17, 2027 |
| Study ends | March 17, 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06893458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 who have a tracheostomy and receive follow-up care through the LIVA unit at Karolinska University Hospital during the March 2025–March 2027 enrollment period and who can complete the full evaluations are ideal candidates.
✕Probably not a fit
Patients who cannot undergo the full evaluation or interviews will not be included and therefore will not directly benefit from this study, and those whose issues are unrelated to feeding may not see actionable changes from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort of children under 18 with tracheostomies followed at the Long-term Intensive Care Unit (LIVA) at Karolinska University Hospital between March 2025 and March 2027. Quality of life will be measured in interviews using the PedsQL generic module 4.0 and swallowing/feeding difficulties will be characterized with the Montreal Children's Hospital Feeding Scale. The study will document the incidence and types of feeding problems and compare PedsQL scores between children with and without feeding difficulties. Data will come from standardized interviews and clinical follow-up within the multidisciplinary LIVA team.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify children at higher risk of poor quality of life and target feeding interventions or supports earlier.
How similar studies have gone: Previous studies have shown that feeding difficulties are common and that children with tracheostomies often report lower quality of life, but detailed correlations using PedsQL and the Montreal Children's Hospital Feeding Scale are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Children below the age of 18 with tracheostomy undergoing follow-up through the Long term Intensive Care Unit at Karolinska University Hospital in Stockholm Sweden between march 2025 and march 2027. Exclusion criteria: Patients that can not undergo full evaluations/examinations will not be included.
Where it's running
-
LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
Solna, Stockholm County, Sweden Recruiting -
LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna
Solna, Stockholm County, Sweden Not yet recruiting
Study contacts
- Study coordinator: Ida Engqvist Engqvist, Medical Doctor
- Email: ida.engqvist@regionstockholm.se
- Phone: +46 (+)768455333
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.