Summary

Eligibility
for people ages 6 months to 25 years (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Robert Venick, MD (ucla)

Description

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.

Details

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.

Keywords

Pediatric Intestinal Failure intestinal failure short bowel syndrome short gut syndrome parenteral nutrition specialized nutrition

Eligibility

You can join if…

Open to people ages 6 months to 25 years

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Mattel Children's Hospital accepting new patients
    Los Angeles California 90095 United States
  • Seattle Children's Hospital accepting new patients
    Seattle Washington 98105 United States

Lead Scientist at UC Health

  • Robert Venick, MD (ucla)
    Professor of Clinical , Pediatrics. Authored (or co-authored) 69 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Children's Hospital
ID
NCT04629014
Study Type
Observational
Last Updated