TolerUp Enteral Feeding Protocol

Abbott

Status: Completed

Conditions: Gastrointestinal Tolerance

Study type: Observational

Funder types: Industry

Identifiers

NCT03648255

DA15

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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