RECRUITING

Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure

Quick Facts

Study Start:2020-02-27

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04629014

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.

Ages Eligible for Study:6 Months to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Biren P Modi, MD MPH

CONTACT

857-218-4651

biren.modi@childrens.harvard.edu

Principal Investigator

Patrick J Javid, MD

PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Biren P Modi, MD MPH

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Children's of Alabama

Birmingham, Alabama, 35233

United States

Lurie Children's Hospital

Chicago, Illinois, 60611

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

St. Louis Children's Hospital

Saint Louis, Missouri, 63100

United States

Duke Children's Hospital

Durham, North Carolina, 27710

United States

Dallas Children's Hospital

Dallas, Texas, 75390

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

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 Registration Dates

Study Start Date2020-02-27

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-02-27

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Pediatric Intestinal Failure