Clinical trial NCT01946503: Infant & Toddler Short Gut Feeding Outcomes Study
Official title: Infant & Toddler Short Gut Feeding Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Intestinal Failure
Home Parenteral Nutrition
Keywords: Short Gut
Short Bowel Syndrome
Intestinal Failure
Home parenteral nutrition
Feeding Behavior
Enteral Nutrition
Parent-Child Relations
Parenteral Nutrition
Digestive System Diseases
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

Eligibility 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

Primary outcomes:
measure: Retrospective data
timeFrame: up to 1 year
Secondary outcomes:
measure: Validated Questionnaires
timeFrame: 2 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Russell J Merritt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.