Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-02 @ 10:49 PM
Study NCT ID:
NCT06893458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding Difficulties and Quality of Life in Children with Tracheal Cannula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-03-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding difficulties in Children with Tracheostomy', 'timeFrame': '2 years', 'description': "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."}, {'measure': 'Quality of Life in children with Tracheostomy', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Association between Quality of life and presens of feeding difficulties', 'timeFrame': '2 years', 'description': 'Measures of Quality of Life measures through PedsQl are related to the presens of feeding difficulty measured through the Montreal Childrens Hospital Feeding Scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric quality of life', 'caregiver quality of life', 'swallowing related quality of life', 'feeding difficulties', 'pediatric tracheostomy'], 'conditions': ['Quality of Life (QOL)', 'Tracheostomy', 'Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter', 'Feeding Difficulties', 'Swallowing Difficulties', 'Caregiver Quality of Life']}, 'referencesModule': {'references': [{'pmid': '38508881', 'type': 'BACKGROUND', 'citation': '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': '11468499', 'type': 'BACKGROUND', 'citation': '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': '22379377', 'type': 'BACKGROUND', 'citation': "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': '17634123', 'type': 'BACKGROUND', 'citation': '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': '36331620', 'type': 'BACKGROUND', 'citation': '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': '34172203', 'type': 'BACKGROUND', 'citation': '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': '32700397', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe main questions it aims to answer are\n\n1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?\n2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL?\n3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula?\n\nQuality 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.", 'detailedDescription': "Background:\n\nChildren 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.\n\nStudies 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.\n\nMain objective:\n\nTo 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.\n\nResearch questions:\n\nPrimary: 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?\n\nMethod: 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.\n\nMeasures 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.\n\nEthical approval has been obtained, ref. no 2023-07493-01."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': '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.\n\nExclusion criteria: Patients that can not undergo full evaluations/examinations will not be included.'}, 'identificationModule': {'nctId': 'NCT06893458', 'briefTitle': 'Feeding Difficulties and Quality of Life in Children with Tracheal Cannula', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Feeding Difficulties and Quality of Life in Children with Tracheal Cannula', 'orgStudyIdInfo': {'id': '2023-07493-01-IV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with tracheostomy undergoing at LIVA', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Solna', 'state': 'Stockholm County', 'country': 'Sweden', 'contacts': [{'name': 'Ida Engqvist, Medical Doctor', 'role': 'CONTACT', 'email': 'ida.engqvist@regionstockholm.se', 'phone': '+46(0)768455333'}, {'name': 'Eva Hedlund, Medical Doctor PhD', 'role': 'CONTACT', 'email': 'eva.h.hedlund@regionstockholm.se', 'phone': '+46(0)707421285'}], 'facility': 'LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': '17176', 'city': 'Solna', 'state': 'Stockholm County', 'country': 'Sweden', 'contacts': [{'name': 'Eva Hedlund, Medical Doctor PhD', 'role': 'CONTACT', 'email': 'eva.h.hedlund@regionstockholm.se', 'phone': '+46(0)707421285'}], 'facility': 'LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'centralContacts': [{'name': 'Ida Engqvist Engqvist, Medical Doctor', 'role': 'CONTACT', 'email': 'ida.engqvist@regionstockholm.se', 'phone': '+46 (+)768455333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Ida Engqvist', 'investigatorAffiliation': 'Karolinska Institutet'}}}}