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Understanding Quality of Life in Children with Intestinal Failure

This study aims to understand and describe the quality of life for children and young adults (ages 6 months to 25 years) who have intestinal failure. Intestinal failure means their intestines don't work well enough, often requiring special nutritional support. Researchers want to find out what medical and social factors affect their quality of life. This is an observational study, meaning participants will be followed as part of their regular care at intestinal rehabilitation programs in the U.S. and Canada. The study will measure health-related quality of life at the beginning and track changes over five years. The goal is to improve support and treatment for these children and their families. The study plans to include 750 participants, but its current status is unclear.

Study design
This is an observational study that plans to include 750 participants. It will collect information from multiple centers across the United States and Canada.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' health-related quality of life will be tracked over five years.

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NCT04629014

Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure

Recruiting
Not specifiedAges 6–25Observational
Boston Children's Hospital
~750 participants
Updated 2026-03-23 on ClinicalTrials.gov

At a glance

Recruiting sites
13 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Health-related quality of life (hrQOL)
Measured over Baseline
+3 more outcomes measured

Conditions

Pediatric Intestinal Failure

Explore related trials

Intestinal FailureShort Bowel Syndrome

Where it's being run

14 sites across 13 states
Texas2
Alabama1
Colorado1
Connecticut1
Illinois1
Massachusetts1
Michigan1
Missouri1

Study leadership

  • Patrick J Javid, MD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital
  • Biren P Modi, MD MPH · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Biren P Modi, MD MPH
[email protected]
857-218-4651
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Health-related quality of life (hrQOL)Baseline

    hrQOL as determined by PedsQL Generic Core at time of enrollment and corrected for time from onset of disease

  • Health-related quality of life (hrQOL) Change over timeTrend 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

  • Disease-specific Health-related quality of life (hrQOL)Baseline

    Disease-specific hrQOL as determined by PedsQL GI Symptoms Scale at time of enrollment and corrected for time from onset of disease

  • Disease-specific Health-related quality of life (hrQOL)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