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Infant & Toddler Short Gut Feeding Outcomes Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Children's Hospital Los Angeles
Sponsor:
Information provided by (Responsible Party):
Russell Merritt, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01946503
First received: September 17, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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


Condition
Short Bowl Syndrome
Intestinal Failure
Home Parenteral Nutrition Following Initial Hospital Discharge

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Infant & Toddler Short Gut Feeding Outcomes Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Retrospective data [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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:
  • Validated Questionnaires [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Months to 6 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946503

Locations
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
Investigators
Principal Investigator: Russell J Merritt, MD, PhD Children's Hospital Los Angeles
  More Information

Publications:

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
Study First Received: September 17, 2013
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014