TolerUp Enteral Feeding Protocol
- Conditions
- Gastrointestinal Tolerance
- Registration Number
- NCT03648255
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastro-Intestinal Tolerance Baseline to 6 months healthcare professional assessed
- Secondary Outcome Measures
Name Time Method Anthropometrics Baseline to 6 months change in weight from baseline measurement
Care Giver Satisfaction of Enteral Product Baseline to 6 months survey administered by healthcare professional
Trial Locations
- Locations (19)
Çukurova University Medical Faculty
🇹🇷Adana, Turkey
Hacettepe Üniversitesi University Medical Faculty
🇹🇷Ankara, Turkey
Ankara Dışkapı Child Disease Hospital
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Bursa Yüksek İhtisas Research and Training Hospital
🇹🇷Bursa, Turkey
Pamukkale Üniversitesi University Medical Faculty
🇹🇷Denizli, Turkey
Elazığ University Medical Faculty
🇹🇷Elazığ, Turkey
Eskişehir Osmangazi University Medical Faculty
🇹🇷Eskişehir, Turkey
Koç University Medical Faculty
🇹🇷Istanbul, Turkey
Scroll for more (9 remaining)Çukurova University Medical Faculty🇹🇷Adana, Turkey