TolerUp Enteral Feeding Protocol

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.

Completed

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Key information

Conditions

Gastrointestinal Tolerance

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Çukurova University Medical Faculty, Adana, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Gastro-Intestinal Tolerance

Time frame: Baseline to 6 months

healthcare professional assessed

Secondary outcomes

Anthropometrics

Time frame: Baseline to 6 months

change in weight from baseline measurement
Care Giver Satisfaction of Enteral Product

Time frame: Baseline to 6 months

survey administered by healthcare professional

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Aug 27, 2018
Registry last updated: Nov 3, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed