Understanding quality of life in children with intestinal failure
Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
Boston Children's Hospital · NCT04629014
This study looks at how living with intestinal failure affects the quality of life for children and what factors might make it better or worse for them and their families.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 6 Months to 25 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT04629014 on ClinicalTrials.gov |
What this trial studies
This observational study aims to quantify and describe the quality of life of children suffering from intestinal failure, while identifying the medical and socio-economic factors that influence their well-being. By utilizing data from multiple multidisciplinary intestinal failure centers across the United States and Canada, the study seeks to fill the knowledge gap regarding the specific challenges faced by these patients and their families. The focus is on health-related quality of life, which encompasses physical, psychological, and social aspects, as mortality rates have decreased and long-term morbidity has become a primary concern. Insights gained from this research could lead to improved support services and tailored medical treatments for pediatric intestinal failure patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 25 years diagnosed with intestinal failure who are part of an intestinal rehabilitation program.
Not a fit: Patients outside the age range of 6 months to 25 years or those not currently receiving specialized nutritional support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for children with intestinal failure by informing better care practices and support services.
How similar studies have performed: While studies on quality of life in pediatric populations are common, this specific multi-site approach focusing on intestinal failure is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be followed in a participating institution's intestinal rehabilitation program * Participants will have a diagnosis of intestinal failure due to functional or structural intestinal dysfunction with current or prior history of specialized nutritional support (parenteral nutrition requirement for 60 out of 74 consecutive days) * Participants will be age 6 months to 25 years old. * Parents/caregivers must be able to complete questionnaire without assistance. * English or Spanish speaking Exclusion Criteria: * Participants aged less than 6 months or greater than 25 years will not be included in this study * Participants will not be enrolled less than 3 months from index admission or initial outpatient evaluation * Participants will not be enrolled less than 1 month from inpatient admission (any admission greater than 24 hours in duration) * Participants will not be enrolled less than 1 month from any operative intervention requiring general anesthesia. * Primary language other than English or Spanish. * Participants who have a currently functional small bowel, liver/small bowel or multivisceral transplant * While other major co-morbidities may be excluded at a later time during data analysis, or may be analyzed as a specific sub-group, they will not be excluded outright. For example, participants with global developmental delay may have parent surveys only, and therefore would need to be excluded from paired analysis of proxy vs. participant perception of HRQOL
Where this trial is running
Birmingham, Alabama and 13 other locations
- Children's of Alabama — Birmingham, Alabama, United States (NOT_YET_RECRUITING)
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (RECRUITING)
- Lurie Children's Hospital — Chicago, Illinois, United States (RECRUITING)
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (RECRUITING)
- St. Louis Children's Hospital — St Louis, Missouri, United States (RECRUITING)
- Duke Children's Hospital — Durham, North Carolina, United States (RECRUITING)
- Dallas Children's Hospital — Dallas, Texas, United States (RECRUITING)
- UT Health Houston — Houston, Texas, United States (RECRUITING)
- Seattle Children's Hospital — Seattle, Washington, United States (RECRUITING)
- Alberta Children's Hospital — Calgary, Alberta, Canada (RECRUITING)
- BC Children's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Patrick J Javid, MD — Seattle Children's Hospital
- Study coordinator: Biren P Modi, MD MPH
- Email: biren.modi@childrens.harvard.edu
- Phone: 857-218-4651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Intestinal Failure, intestinal failure, short bowel syndrome, short gut syndrome, parenteral nutrition, specialized nutrition