Feeding Difficulties and Quality of Life in Children With Tracheal Cannula

NCT06893458 | Recruiting

• 1 other identifier: 2023-07493-01-IV
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Quality of Life (QOL); Tracheostomy; Feeding Difficulties; Swallowing Difficulties; Caregiver Quality of Life; Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter

Keywords

pediatric quality of life; caregiver quality of life; swallowing related quality of life; feeding difficulties; pediatric tracheostomy

Outcome Measures

Primary Outcomes (2)

• Feeding difficulties in Children with Tracheostomy

  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

  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 Outcomes (1)

• Association between Quality of life and presens of feeding difficulties

  2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (2)

LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna

Solna, Stockholm County, 17176, Sweden

NOT YET RECRUITING

LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden

Solna, Stockholm County, 17176, Sweden

RECRUITING

Related Publications (7)

• Raynor EM, Wohl D. Tracheostomy-Related Swallowing Issues in Children. Otolaryngol Clin North Am. 2024 Aug;57(4):649-655. doi: 10.1016/j.otc.2024.02.017. Epub 2024 Mar 19.

  PMID: 38508881 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.

  PMID: 22379377 BACKGROUND

• Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43.

  PMID: 17634123 BACKGROUND

• Bergmann S, Ritz LA, Widenmann-Grolig A, Jechalke S, von Schweinitz D, Hubertus J, Lurz E. Swallowing-related quality of life in children with oesophageal atresia: a national cohort study. Eur J Pediatr. 2023 Jan;182(1):275-283. doi: 10.1007/s00431-022-04677-4. Epub 2022 Nov 4.

  PMID: 36331620 BACKGROUND

• Pullens B, Streppel M. Swallowing problems in children with a tracheostomy. Semin Pediatr Surg. 2021 Jun;30(3):151053. doi: 10.1016/j.sempedsurg.2021.151053. Epub 2021 May 21.

  PMID: 34172203 BACKGROUND

• Henningfeld J, Lang C, Erato G, Silverman AH, Goday PS. Feeding Disorders in Children With Tracheostomy Tubes. Nutr Clin Pract. 2021 Jun;36(3):689-695. doi: 10.1002/ncp.10551. Epub 2020 Jul 23.

  PMID: 32700397 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Ida Engqvist Engqvist, Medical Doctor

CONTACT

+46 (+)768455333; ida.engqvist@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): March 17, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

SE (2)