Infant & Toddler Short Gut Feeding Outcomes Study

NCT ID: NCT01946503

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2023-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Short Bowel Syndrome Intestinal Failure Home Parenteral Nutrition

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Short bowel syndrome

Patients followed in a clinic for short bowel syndrome

No interventions assigned to this group

Healthy controls

Patients seen in a general pediatric clinic without chronic or acute diseases

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Russell Merritt

Medical Director, Nutritional Support Team and Intestinal Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell J Merritt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.5014/ajot.44.12.1070.

Reference Type BACKGROUND
PMID: 2126165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21270366 (View on PubMed)

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. doi: 10.1097/00005176-200310000-00014.

Reference Type BACKGROUND
PMID: 14508219 (View on PubMed)

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. doi: 10.1037/0893-3200.20.3.409.

Reference Type BACKGROUND
PMID: 16937997 (View on PubMed)

Engstrom I, Bjornestam 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. doi: 10.1097/00005176-200309000-00008.

Reference Type BACKGROUND
PMID: 12960644 (View on PubMed)

Geertsma MA, Hyams JS, Pelletier JM, Reiter S. Feeding resistance after parenteral hyperalimentation. Am J Dis Child. 1985 Mar;139(3):255-6. doi: 10.1001/archpedi.1985.02140050049020.

Reference Type BACKGROUND
PMID: 3919567 (View on PubMed)

Lacaille F, Vass N, Sauvat F, Canioni D, Colomb V, Talbotec C, De Serre NP, Salomon J, Hugot JP, Cezard JP, Revillon 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. doi: 10.1136/gut.2007.133389. Epub 2007 Dec 13.

Reference Type BACKGROUND
PMID: 18079282 (View on PubMed)

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. doi: 10.1016/j.jpeds.2005.01.034.

Reference Type BACKGROUND
PMID: 15973321 (View on PubMed)

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. doi: 10.1111/j.1365-2214.2004.00437.x.

Reference Type BACKGROUND
PMID: 15320927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22525813 (View on PubMed)

Other Identifiers

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CCI-13-00053

Identifier Type: -

Identifier Source: org_study_id

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