Feeding Difficulties and Quality of Life in Children with Tracheal Cannula
NCT ID: NCT06893458
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2025-03-17
2027-03-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
NCT07121517
Complications Related to the Anaesthesia During Airway Endoscopy in Children with Tracheostomy.
NCT06906263
Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study
NCT06018220
Scoring Method for Describing the Position of a Tracheostomy Tube
NCT01356719
Early Percutaneous Tracheostomy and Swallowing Dysfunction
NCT01268423
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion criteria: Patients that can not undergo full evaluations/examinations will not be included.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ida Engqvist
M.D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna
Solna, Stockholm County, Sweden
LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden
Solna, Stockholm County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-07493-01-IV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.