Infant & Toddler Short Gut Feeding Outcomes Study

NCT01946503 | Completed

• 1 other identifier: CCI-13-00053
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Retrospective data

  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.

  up to 1 year

Secondary Outcomes (1)

• Validated Questionnaires

  2 hours

Study Arms (2)

Short bowel syndrome

Patients followed in a clinic for short bowel syndrome

Healthy controls

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

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Not seen in home TPN clinic
• Short gut with onset \>3 months
• No parents/legal guradians willing to participate in the study

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (10)

• 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.

  PMID: 2126165 BACKGROUND

• 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.

  PMID: 21270366 BACKGROUND

• 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.

  PMID: 14508219 BACKGROUND

• 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.

  PMID: 16937997 BACKGROUND

• 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.

  PMID: 12960644 BACKGROUND

• 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.

  PMID: 3919567 BACKGROUND

• 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.

  PMID: 18079282 BACKGROUND

• 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.

  PMID: 15973321 BACKGROUND

• 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.

  PMID: 15320927 BACKGROUND

• 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.

  PMID: 22525813 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure; Feeding Behavior; Hyperphagia; Digestive System Diseases

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Russell J Merritt, MD, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Nutritional Support Team and Intestinal Rehabilitation

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 19, 2013
• Study Start: April 1, 2013
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)