Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure

March 19, 2026 updated by: Biren Modi, Boston Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Health related quality of life is becoming an increasingly important topic as medical advancements continue to increase life expectancies in various illnesses. Quality of life (QoL) encompasses the physical, psychological, and social well-being of a person. Studies focusing on health related QoL show that providers have a limited understanding of the QoL of their patients, demonstrating a need for further research. Mortality rates in pediatric intestinal failure (PIF) have significantly dropped over the past 3-4 decades and long-term morbidity rather than survival has come into focus as the outcome of interest. However, there remains a significant knowledge gap regarding the specific factors that contribute to QoL among PIF patients and their families. Insight into the challenges these patients face can promote enhanced support services and psycho-education for caregivers of these children as well as help to tailor medical and surgical treatment with a focus on improved QoL. Due to the rare nature of PIF, and despite a recent bloom in multidisciplinary PIF centers, experience is limited in individual centers and a multi-site study with a robust and diverse patient population is optimal to study QoL in pediatric intestinal failure.

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Recruiting
        • BC Children's Hospital
        • Contact:
        • Principal Investigator:
          • Hannah Piper, MD
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Christina Belza, PhD, RN
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • Children's of Alabama
        • Contact:
        • Principal Investigator:
          • David Galloway, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Lindsey Gumer, MD, MSc
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Contact:
        • Principal Investigator:
          • Jonathan Salazar, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital
        • Contact:
        • Principal Investigator:
          • Valeria Cohran, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Biren P Modi, MD MPH
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C.S. Mott Children's Hospital
        • Contact:
        • Principal Investigator:
          • Meghan Arnold, MD
    • Missouri
      • St Louis, Missouri, United States, 63100
        • Recruiting
        • St. Louis Children's Hospital
        • Principal Investigator:
          • Brad Warner, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Children's Hospital
        • Contact:
        • Principal Investigator:
          • Debra Sudan, MD
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
        • Principal Investigator:
          • Essam Imseis, MD
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be children with a specific diagnosis of intestinal failure as determined by parenteral nutrition dependence at any point in their history for more than 60 out of 74 consecutive days who are managed at one of the intestinal rehabilitation programs located at the study participating sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life (hrQOL)
Time Frame: Baseline
hrQOL as determined by PedsQL Generic Core at time of enrollment and corrected for time from onset of disease
Baseline
Health-related quality of life (hrQOL) Change over time
Time Frame: Trend over 5 years
hrQOL as determined by PedsQL Generic Core, assessed annually, looking at trend in change over 5 years of assessment and corrected for time from onset of disease
Trend over 5 years
Disease-specific Health-related quality of life (hrQOL)
Time Frame: Baseline
Disease-specific hrQOL as determined by PedsQL GI Symptoms Scale at time of enrollment and corrected for time from onset of disease
Baseline
Disease-specific Health-related quality of life (hrQOL)
Time Frame: Trend over 5 years
Disease-specific hrQOL as determined by PedsQL GI Symptoms Scale, assessed annually, looking at trend in change over 5 years of assessment and corrected for time from onset of disease
Trend over 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Impact
Time Frame: Baseline
Family impact as determined by the PedsQL Family Impact Module
Baseline
Family Impact
Time Frame: Trend over 5 years
Family impact as assessed by the PedsQL Family Impact Module, assessed annually, looking at trend in change over 5 years of assessment and corrected for time from onset of disease
Trend over 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

The Hospital for Sick Children
The University of Texas Health Science Center, Houston
Washington University School of Medicine
University of Alabama at Birmingham
University of Michigan
Children's Hospital Colorado
Seattle Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
University of Texas Southwestern Medical Center
Duke Health
Alberta Children's Hospital
British Columbia Children's Hospital
Connecticut Children's Medical Center

Investigators

  • Principal Investigator: Patrick J Javid, MD, Seattle Children's Hospital
  • Principal Investigator: Biren P Modi, MD MPH, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00032389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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