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Completed

NCT Number: NCT01946503

Infant & Toddler Short Gut Feeding Outcomes Study

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

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Key information

Conditions

Short Bowel Syndrome Behavior Behavior, Animal Digestive System Diseases Feeding Behavior Gastrointestinal Diseases Home Parenteral Nutrition Hyperphagia Intestinal Diseases Intestinal Failure Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2013
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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