Feeding Difficulties and Quality of Life in Children With Tracheal Cannula

February 12, 2026 updated by: Ida Engqvist, Karolinska Institutet

The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula.

The main questions it aims to answer are

  1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?
  2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL?
  3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula?

Quality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

Children with airway obstruction due to inborn malformations or trauma, or who have a chronic need for respiratory support due to lung- or neuromuscular diseases, may require a tracheostomy. A tracheostomy is a surgical opening of the trachea at the front of the neck to create an artificial airway, maintained with a tracheostomy tube. The Long-term Intensive Care Unit (LIVA) is a unit within Paediatric Perioperative Medicine and Intensive Care (BPMI) at Karolinska University Hospital. Since 1998, its primary task has been to care for children with tracheostomies from a large part of the country and it is the only unit of its kind in Scandinavia. LIVA's follow-up of children with tracheostomies includes regular team assessments and linked to LIVA is a multidisciplinary team consisting of paediatricians, ear-nose-throat specialists, paediatric anaesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counsellors, and play therapists.

Studies indicate that feeding difficulties in children with tracheostomies are common and many have enteral feeding entirely or partially through gastrostomies. Our understanding regarding the types of feeding difficulties that these children experience and the potential causes and consequences however are limited. Studies have shown that both children and parents of children with tracheostomies rate their quality of life far lower than other groups of children with severe chronic diseases. Existing studies however are small involving only 20-25 subjects and studies of the quality of life of tracheostomized children in Sweden and the factors that may determine quality of life is lacking. A study in children with esophageal atresia indicate that the ability to taste food in the mouth is related to increased self assessed quality of life. The association between swallowing difficulties and quality of life in children with tracheostomy has to the best of our knowledge not been investigated before.

Main objective:

To investigate the quality of life in children with tracheostomy and their caregivers and identify the aspects determining it. Feeding difficulties will be studied specifically to investigate if there is an association between the ability to feed orally and self-assessed quality of life.

Research questions:

Primary: Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Secondary: How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? Which factors affect the quality of life in children with a tracheostomy?

Method: This is a prospective observational study. The 80 children currently undergoing regular follow-up at LIVA will be eligible for inclusion. Quality of life assessment by both children and parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare. Swallowing difficulties are assessed through evaluations based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children. Each assessment takes approximately 10min and will take place within the framework of the multidisciplinary team visits that the children associated with LIVA participate in.

Measures of quality of life are compared with data from other populations in the PedsQL database and related to the scores regarding feeding difficulties derived from the Montreal Feeding Scale.

Ethical approval has been obtained, ref. no 2023-07493-01.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 17176
      • Solna, Stockholm County, Sweden, 17176
        • Recruiting
        • LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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 jan 2025 and jan 2027. About 80 patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children with tracheostomy undergoing at LIVA
All children under 18 years with tracheostomy undergoing follow-up through the long term intensive care unit LIVA at Karolinska University Hospital Solna, Sweden will be eligible for inclusion. This is a majority of the children living with tracheostomy in Sweden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding difficulties in Children with Tracheostomy
Time Frame: 2 years
Feeding difficulties are assessed based on The Montreal Children's Hospital Feeding Scale, a validated tool used to assess and monitor the feeding abilities and behaviors of infants and young children.
2 years
Quality of Life in children with Tracheostomy
Time Frame: 2 years
Quality of life assessment by children with tracheostomy and their parents is conducted using the PedsQL instrument, generic module 4.0. This validated tool is a questionnaire with 23 questions covering four domains: health/activities, emotions, social functioning, and school/daycare.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Quality of life and presens of feeding difficulties
Time Frame: 2 years
Measures of Quality of Life measures through PedsQl are related to the presens of feeding difficulty measured through the Montreal Childrens Hospital Feeding Scale.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

March 17, 2027

Study Completion (Estimated)

March 17, 2027

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07493-01-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tracheostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe