Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
NCT ID: NCT04629014
Last Updated: 2024-12-18
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
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RECRUITING
750 participants
OBSERVATIONAL
2020-02-27
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Months
25 Years
ALL
No
Sponsors
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Seattle Children's Hospital
OTHER
University of Alabama at Birmingham
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Washington University School of Medicine
OTHER
University of Michigan
OTHER
Duke Health
OTHER
University of Texas Southwestern Medical Center
OTHER
Alberta Children's Hospital
OTHER
British Columbia Children's Hospital
OTHER
The Hospital for Sick Children
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Biren Modi
Surgical Director, Center for Advanced Intestinal Rehabilitation
Principal Investigators
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Patrick J Javid, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Biren P Modi, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Duke Children's Hospital
Durham, North Carolina, United States
Dallas Children's Hospital
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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David Galloway, MD
Role: primary
Valeria Cohran, MD
Role: primary
Biren P Modi, MD MPH
Role: primary
Meghan Arnold, MD
Role: primary
Brad Warner, MD
Role: primary
Debra Sudan, MD
Role: primary
Nandini Channabasappa, MD
Role: primary
Patrick J Javid, MD
Role: primary
Dana Boctor, MD
Role: primary
Hannah Piper, MD
Role: primary
Paul Wales, MD
Role: primary
References
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Diamond IR, de Silva N, Pencharz PB, Kim JH, Wales PW; Group for the Improvement of Intestinal Function and Treatment. Neonatal short bowel syndrome outcomes after the establishment of the first Canadian multidisciplinary intestinal rehabilitation program: preliminary experience. J Pediatr Surg. 2007 May;42(5):806-11. doi: 10.1016/j.jpedsurg.2006.12.033.
Javid PJ, Malone FR, Reyes J, Healey PJ, Horslen SP. The experience of a regional pediatric intestinal failure program: Successful outcomes from intestinal rehabilitation. Am J Surg. 2010 May;199(5):676-9. doi: 10.1016/j.amjsurg.2010.01.013.
Modi BP, Langer M, Ching YA, Valim C, Waterford SD, Iglesias J, Duro D, Lo C, Jaksic T, Duggan C. Improved survival in a multidisciplinary short bowel syndrome program. J Pediatr Surg. 2008 Jan;43(1):20-4. doi: 10.1016/j.jpedsurg.2007.09.014.
Mutanen A, Kosola S, Merras-Salmio L, Kolho KL, Pakarinen MP. Long-term health-related quality of life of patients with pediatric onset intestinal failure. J Pediatr Surg. 2015 Nov;50(11):1854-8. doi: 10.1016/j.jpedsurg.2015.05.012. Epub 2015 Jun 3.
Norsa L, Artru S, Lambe C, Talbotec C, Pigneur B, Ruemmele F, Colomb V, Capito C, Chardot C, Lacaille F, Goulet O. Long term outcomes of intestinal rehabilitation in children with neonatal very short bowel syndrome: Parenteral nutrition or intestinal transplantation. Clin Nutr. 2019 Apr;38(2):926-933. doi: 10.1016/j.clnu.2018.02.004. Epub 2018 Feb 15.
Sanchez SE, McAteer JP, Goldin AB, Horslen S, Huebner CE, Javid PJ. Health-related quality of life in children with intestinal failure. J Pediatr Gastroenterol Nutr. 2013 Sep;57(3):330-4. doi: 10.1097/MPG.0b013e3182999961.
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.
Modi BP, Piper HG, Belza C, Staffa S, Arnold MA, Boctor DL, Channabasappa N, Cohran VC, Galloway DP, Sudan D, Wales PW, Warner BW, Murtadi G, Javid PJ. Health-Related Quality of Life in Pediatric Intestinal Failure from Infancy to Adolescence: An International, Multi-Center Evaluation. J Pediatr. 2025 Jul;282:114566. doi: 10.1016/j.jpeds.2025.114566. Epub 2025 Mar 28.
Other Identifiers
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P00032389
Identifier Type: -
Identifier Source: org_study_id