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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Cukurova University Medical Faculty
  • Ankara, Turkey, 06500
    • Gazi University Medical Faculty
  • Ankara, Turkey, 06100
    • Hacettepe Üniversitesi University Medical Faculty
  • Ankara, Turkey, 06110
    • Ankara Dışkapı Child Disease Hospital
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty
  • Bursa, Turkey, 16310
    • Bursa Yuksek ihtisas research and training hospital
  • Denizli, Turkey, 20070
    • Pamukkale Üniversitesi University Medical Faculty
  • Elazığ, Turkey, 23119
    • Elazığ University Medical Faculty
  • Eskişehir, Turkey, 26480
    • Eskisehir Osmangazi University Medical Faculty
  • Istanbul, Turkey, 34010
    • Koç University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli Üniversitesi University Medical Faculty
  • Kırıkkale, Turkey, 71450
    • Kırıkkale University Medical Faculty
  • Malatya, Turkey, 44280
    • İnönü Üniversitesi University Medical Faculty
  • Samsun, Turkey, 55280
    • Ondokuz Mayıs University Medical Faculty
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik University Medical Faculty
  • İstanbul, Turkey, 34303
    • İstanbul Kanuni Sultan Süleyman Research and Training Hospital
  • İstanbul, Turkey, 34371
    • İstanbul Şişli Hamidiye Etfal Research and Training Hospital
  • İstanbul, Turkey, 34764
    • İstanbul Ümraniye Research and Training Hospital
  • İzmir, Turkey, 35210
    • İzmir Behçet Uz Child Disease Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometrics	change in weight from baseline measurement	Baseline to 6 months
Care Giver Satisfaction of Enteral Product	survey administered by healthcare professional	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Aysugul Alptekin, MD, Abbott Turkey

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): July 20, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DA15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No