Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-03-29 @ 5:16 AM
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:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Feeding Difficulties and Quality of Life in Children with Tracheal Cannula
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: