Recruiting

Observational StudyProspective Multisite Study of Quality of Life in Pediatric Intestinal Failure

Sponsor:

Boston Children's Hospital

Code:

NCT04629014

Conditions

Pediatric Intestinal Failure

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Pediatric Intestinal Failure

Study ID

NCT04629014

Start date

Feb 27, 2020

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Health-related quality of life (hrQOL) [ Time Frame: Baseline ]
Health-related quality of life (hrQOL) Change over time [ Time Frame: Trend over 5 years ]
Disease-specific Health-related quality of life (hrQOL) [ Time Frame: Baseline ]
Disease-specific Health-related quality of life (hrQOL) [ Time Frame: Trend over 5 years ]

Central Contacts and Locations

Central contacts

Biren P Modi, MD MPH

857-218-4651 biren.modi@childrens.harvard.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Lindsey Gumer, MD, MSc

720-777-6669 lindsey.gumer@childrenscolorado.org

Principal Investigator:

Lindsey Gumer, MD, MSc

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Jonathan Salazar, MD

860-545-9560 jsalazar02@connecticutchildrens.org

Principal Investigator:

Jonathan Salazar, MD

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Valeria Cohran, MD

vcohran@luriechildrens.org

Principal Investigator:

Valeria Cohran, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Biren P Modi, MD MPH

857-218-4651 biren.modi@childrens.harvard.edu

Principal Investigator:

Biren P Modi, MD MPH

C.S. Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Meghan Arnold, MD

meghanar@med.umich.edu

Principal Investigator:

Meghan Arnold, MD

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63100

Contacts

Brad Warner, MD

brad.warner@wustl.edu

Principal Investigator:

Brad Warner, MD

Duke Children's Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Debra Sudan, MD

debra.sudan@duke.edu

Principal Investigator:

Debra Sudan, MD

Dallas Children's Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Nandini Channabasappa, MD

nandini.channabasappa@utsouthwestern.edu

Principal Investigator:

Nandini Channabasappa, MD

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Essam Imseis, MD

713-500-5663 essam.imseis@uth.tmc.edu

Principal Investigator:

Essam Imseis, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Patrick J Javid, MD

patrick.javid@seattlechildrens.org

Principal Investigator:

Patrick J Javid, MD

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Dana Boctor, MD

dana.boctor@albertahealthservices.ca

Principal Investigator:

Dana Boctor, MD

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Hannah Piper, MD

hannah.piper@cw.bc.ca

Principal Investigator:

Hannah Piper, MD

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Christina Belza, PhD, RN

416-813-5347 christina.belza@sickkids.ca

Principal Investigator:

Christina Belza, PhD, RN

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

intestinal failure
short bowel syndrome
short gut syndrome
parenteral nutrition
specialized nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-23.