Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-26 @ 12:07 PM
Study NCT ID:
NCT01946503
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infant & Toddler Short Gut Feeding Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective data', 'timeFrame': 'up to 1 year', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Validated Questionnaires', 'timeFrame': '2 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Short Gut', 'Short Bowel Syndrome', 'Intestinal Failure', 'Home parenteral nutrition', 'Feeding Behavior', 'Enteral Nutrition', 'Parent-Child Relations', 'Parenteral Nutrition', 'Digestive System Diseases'], 'conditions': ['Short Bowel Syndrome', 'Intestinal Failure', 'Home Parenteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '2126165', 'type': 'BACKGROUND', '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.'}, {'pmid': '21270366', 'type': 'BACKGROUND', '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.'}, {'pmid': '14508219', 'type': 'BACKGROUND', '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."}, {'pmid': '16937997', 'type': 'BACKGROUND', '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.'}, {'pmid': '12960644', 'type': 'BACKGROUND', '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.'}, {'pmid': '3919567', 'type': 'BACKGROUND', '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.'}, {'pmid': '18079282', 'type': 'BACKGROUND', '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.'}, {'pmid': '15973321', 'type': 'BACKGROUND', '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.'}, {'pmid': '15320927', 'type': 'BACKGROUND', '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.'}, {'pmid': '22525813', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand why children with short gut develop feeding problems.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen in home-TPN clinic and subjects who meet the inclusion criteria will be invited to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen in home-TPN clinic since July of 2008 with:\n* Intestinal failure\n* Short gut\n* Onset \\< 3 months of age\n* Received home parenteral nutrition following initial hospital discharge\n* Less than 7 years of age at time of study\n* Must have at least 1 parent/legal guradian willing to participate in the study\n\nExclusion Criteria:\n\n* Not seen in home TPN clinic\n* Short gut with onset \\>3 months\n* No parents/legal guradians willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT01946503', 'briefTitle': 'Infant & Toddler Short Gut Feeding Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Infant & Toddler Short Gut Feeding Outcomes Study', 'orgStudyIdInfo': {'id': 'CCI-13-00053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short bowel syndrome', 'description': 'Patients followed in a clinic for short bowel syndrome'}, {'label': 'Healthy controls', 'description': 'Patients seen in a general pediatric clinic without chronic or acute diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Russell J Merritt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Nutritional Support Team and Intestinal Rehabilitation', 'investigatorFullName': 'Russell Merritt', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}