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Infant & Toddler Short Gut Feeding Outcomes Study

This study is currently recruiting participants.
Verified March 2017 by Russell Merritt, Children's Hospital Los Angeles
Sponsor:
ClinicalTrials.gov Identifier:
NCT01946503
First Posted: September 19, 2013
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Russell Merritt, Children's Hospital Los Angeles
  Purpose
The purpose of this study is to better understand why children with short gut develop feeding problems.

Condition
Short Bowel Syndrome Intestinal Failure Home Parenteral Nutrition

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 Russell Merritt, Children's Hospital Los Angeles:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (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

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.
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
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


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:
Bazyk S. Factors associated with the transition to oral feeding in infants fed by nasogastric tubes. Am J Occup Ther. 1990 Dec;44(12):1070-8.
Black MM, Aboud FE. Responsive feeding is embedded in a theoretical framework of responsive parenting. J Nutr. 2011 Mar;141(3):490-4. doi: 10.3945/jn.110.129973. Epub 2011 Jan 26.
Byars KC, Burklow KA, Ferguson K, O'Flaherty T, Santoro K, Kaul A. A multicomponent behavioral program for oral aversion in children dependent on gastrostomy feedings. J Pediatr Gastroenterol Nutr. 2003 Oct;37(4):473-80.
Davies WH, Satter E, Berlin KS, Sato AF, Silverman AH, Fischer EA, Arvedson JC, Rudolph CD. Reconceptualizing feeding and feeding disorders in interpersonal context: the case for a relational disorder. J Fam Psychol. 2006 Sep;20(3):409-17. Review.
Engström I, Björnestam B, Finkel Y. Psychological distress associated with home parenteral nutrition in Swedish children, adolescents, and their parents: preliminary results. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):246-50.
Geertsma MA, Hyams JS, Pelletier JM, Reiter S. Feeding resistance after parenteral hyperalimentation. Am J Dis Child. 1985 Mar;139(3):255-6.
Lacaille F, Vass N, Sauvat F, Canioni D, Colomb V, Talbotec C, De Serre NP, Salomon J, Hugot JP, Cézard JP, Révillon Y, Ruemmele FM, Goulet O. Long-term outcome, growth and digestive function in children 2 to 18 years after intestinal transplantation. Gut. 2008 Apr;57(4):455-61. Epub 2007 Dec 13.
Gottrand F, Staszewski P, Colomb V, Loras-Duclaux I, Guimber D, Marinier E, Breton A, Magnificat S. Satisfaction in different life domains in children receiving home parenteral nutrition and their families. J Pediatr. 2005 Jun;146(6):793-7.
Pedersen SD, Parsons HG, Dewey D. Stress levels experienced by the parents of enterally fed children. Child Care Health Dev. 2004 Sep;30(5):507-13.
Wilken M. The impact of child tube feeding on maternal emotional state and identity: a qualitative meta-analysis. J Pediatr Nurs. 2012 Jun;27(3):248-55. doi: 10.1016/j.pedn.2011.01.032. Epub 2011 Mar 15.

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 Submitted: September 17, 2013
First Posted: September 19, 2013
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


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