An observational study in Pediatric Intestinal Failure, sponsored by Boston Children's Hospital. Recruiting at 14 sites in 2 countries. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Boston Children's Hospital · Observational
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 750 is above the median of 60 across 19 observational studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Health-related quality of life (hrQOL)
hrQOL as determined by PedsQL Generic Core at time of enrollment and corrected for time from onset of disease
Time frame: Baseline
Health-related quality of life (hrQOL) Change over time
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
Time frame: Trend over 5 years
Disease-specific Health-related quality of life (hrQOL)
Disease-specific hrQOL as determined by PedsQL GI Symptoms Scale at time of enrollment and corrected for time from onset of disease
Time frame: Baseline
Disease-specific Health-related quality of life (hrQOL)
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
Time frame: Trend over 5 years
Family Impact
Family impact as determined by the PedsQL Family Impact Module
Time frame: Baseline
Family Impact
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
Time frame: Trend over 5 years
Plan to share: No
Started Feb 2020 (actual). Primary completion is estimated for Dec 2029, 118 months after the start.
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