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TolerUp Enteral Feeding Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648255
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.

Condition or disease
Gastrointestinal Tolerance

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Study Type : Observational
Estimated Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020



Primary Outcome Measures :
  1. Gastro-Intestinal Tolerance [ Time Frame: Baseline to 6 months ]
    healthcare professional assessed


Secondary Outcome Measures :
  1. Anthropometrics [ Time Frame: Baseline to 6 months ]
    change in weight from baseline measurement

  2. Care Giver Satisfaction of Enteral Product [ Time Frame: Baseline to 6 months ]
    survey administered by healthcare professional



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be composed of patients aged 1-12 and under follow-up in participating study centers in Turkey.
Criteria

Inclusion Criteria:

  • Diagnosis of cerebral palsy
  • Fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance
  • Fed by tube, using enteral tube feeding as sole source of nutrition
  • A signed and dated informed consent by subject's legally acceptable representative

Exclusion Criteria:

  • Chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy)
  • Intestinal obstruction
  • Dialysis treatment
  • Requirement of artificial ventilation
  • Requirement of parenteral nutrition
  • Normal nutrition in addition to enteral tube feeding
  • Allergy or intolerance to any ingredient of the study product
  • Currently participating in another clinical or non-clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648255


Contacts
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Contact: Kristen DeLuca 614-624-5455 kristen.deluca@abbott.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Aysugül Alptekin, MD Abbott Turkey

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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03648255    
Other Study ID Numbers: DA15
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No