TolerUp Enteral Feeding Protocol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03648255

Enrollment

133

Registered

2018-08-27

Start date

2018-02-19

Completion date

2020-07-20

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Tolerance

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Gastro-Intestinal Tolerance	Baseline to 6 months	healthcare professional assessed

Secondary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results