Infant & Toddler Short Gut Feeding Outcomes Study

Completed

• Conditions: Short Bowel Syndrome; Intestinal Failure; Home Parenteral Nutrition

• Registration Number: NCT01946503
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

The purpose of this study is to better understand why children with short gut develop feeding problems.

Detailed Description

We seek to identify characteristics of our patients' histories that are associated with feeding problems in the context of availability of early prophylactic occupational therapy. We plan to review our most recent four years' experience in children with short gut syndrome with onset in early infancy who initially required home parenteral nutrition to identify risk factors or clusters of risk factors associated with food aversion.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-19
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Patients seen in home-TPN clinic since July of 2008 with:
• Intestinal failure
• Short gut
• Onset < 3 months of age
• Received home parenteral nutrition following initial hospital discharge
• Less than 7 years of age at time of study
• Must have at least 1 parent/legal guradian willing to participate in the study

Exclusion Criteria

• Not seen in home TPN clinic
• Short gut with onset >3 months
• No parents/legal guradians willing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective data	up to 1 year	Data will be reviewed starting at the patient's birth. We will only be looking at patients who have been seen in the clinic since July 1, 2008; some of these will have medical records going back as early as 2006. We will continue to collect future data for up to 1 year from the beginning of data collection.

Secondary Outcome Measures

Name	Time	Method
Validated Questionnaires	2 hours	Validated questionnaires (where available) will be administered prospectively to grade current feeding competence for age, assess developmental status, assess food preferences and score parental stress. Only the food preference questionnaire will be administered to the healthy control group.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States