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Clinical Trials/NCT01946503
NCT01946503CompletedNot Applicable

Infant & Toddler Short Gut Feeding Outcomes Study

Children's Hospital Los Angeles1 site in 1 country58 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Retrospective data

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Other

Eligibility Criteria

Ages
3 Months to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Retrospective data

Time Frame: 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 Outcomes

  • Validated Questionnaires(2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Russell Merritt

Medical Director, Nutritional Support Team and Intestinal Rehabilitation

Children's Hospital Los Angeles

Study Sites (1)

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