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CompletedNCT01946503Updated Sep 21, 2023

Infant & Toddler Short Gut Feeding Outcomes Study

An observational study in Short Bowel Syndrome, Intestinal Failure and Home Parenteral Nutrition, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 3 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Children's Hospital Los Angeles · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
58
Ages
3 Months to 6 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

This study's enrollment of 58 is close to the median of 53 across 36 observational studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not seen in home TPN clinic
  • Short gut with onset >3 months
  • No parents/legal guradians willing to participate in the study
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
58 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: up to 1 year

Secondary outcomes

  1. Validated Questionnaires

    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. Only the food preference questionnaire will be administered to the healthy control group.

    Time frame: 2 hours

07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
08

References and documents

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. doi: 10.5014/ajot.44.12.1070. PubMed 2126165 ↗
  • 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. PubMed 21270366 ↗
  • 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. PubMed 14508219 ↗
  • 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. PubMed 16937997 ↗
  • 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. PubMed 12960644 ↗
  • 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. PubMed 3919567 ↗
  • 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. PubMed 18079282 ↗
  • 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. PubMed 15973321 ↗
  • 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. PubMed 15320927 ↗
  • 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. PubMed 22525813 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2013 to primary completion in May 2023, 121 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2013
First posted
Sep 19, 2013
StartActual
Apr 2013
Primary completionActual
May 31, 2023
CompletionActual
May 31, 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01946503
Responsible party
Russell Merritt (Medical Director, Nutritional Support Team and Intestinal Rehabilitation, Children's Hospital Los Angeles) — Principal investigator
First posted
Sep 19, 2013
Start date
Apr 2013
Primary completion
May 31, 2023
Completion
May 31, 2023
Last update
Sep 21, 2023

Study contacts

Russell J Merritt, MD, PhD
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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