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Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
RecruitingObservational study
Who can join
6 Months – 25 Years · All sexes
Full eligibility 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
About the study
This study proposes to quantify and describe the quality of life of children with intestinal failure, and to identify the medical and socio-economic factors that impact this quality of life, using data from multiple multidisciplinary intestinal failure centers across the United States and Canada specializing in the care of these participants.
Sponsor: Boston Children's Hospital · Participants: 750 · Started: Feb 27, 2020
Contact the study team
- Biren P Modi, MD MPH · Phone: 857-218-4651
Official record on ClinicalTrials.gov — NCT04629014
Locations in the U.S.
| Alabama | Children's of Alabama, Birmingham (Not yet recruiting) |
| Colorado | Children's Hospital Colorado, Aurora |
| Connecticut | Connecticut Children's Medical Center, Hartford |
| Illinois | Lurie Children's Hospital, Chicago |
| Massachusetts | Boston Children's Hospital, Boston |
| Michigan | C.S. Mott Children's Hospital, Ann Arbor |
| Missouri | St. Louis Children's Hospital, St Louis |
| North Carolina | Duke Children's Hospital, Durham |
| Texas | Dallas Children's Hospital, Dallas UT Health Houston, Houston |
| Washington | Seattle Children's Hospital, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.