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Infant & Toddler Short Gut Feeding Outcomes Study

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ClinicalTrials.gov Identifier: NCT01946503
Recruitment Status : Recruiting
First Posted : September 19, 2013
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to better understand why children with short gut develop feeding problems.

Condition or disease
Short Bowel Syndrome Intestinal Failure Home Parenteral Nutrition

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
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Infant & Toddler Short Gut Feeding Outcomes Study
Study Start Date : April 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Validated Questionnaires [ Time Frame: 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in home-TPN clinic and subjects who meet the inclusion criteria will be invited to participate.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946503

United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Miriam E Federman, BA       miriam.ferdman@gmail.com   
Principal Investigator: Russell J Merritt, M.D., Ph.D.         
Sponsors and Collaborators
Children's Hospital Los Angeles
Principal Investigator: Russell J Merritt, MD, PhD Children's Hospital Los Angeles
More Information


Responsible Party: Russell Merritt, Medical Director, Nutritional Support Team and Intestinal Rehabilitation, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01946503     History of Changes
Other Study ID Numbers: CCI-13-00053
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Russell Merritt, Children's Hospital Los Angeles:
Short Gut
Short Bowel Syndrome
Intestinal Failure
Home parenteral nutrition
Feeding Behavior
Enteral Nutrition
Parent-Child Relations
Parenteral Nutrition
Digestive System Diseases

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes