TolerUp Enteral Feeding Protocol

Completed

• 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

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & 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)

Gazi University Medical Faculty; 🇹🇷 Ankara, Turkey

Koç University Medical Faculty; 🇹🇷 Istanbul, Turkey

Eskişehir Osmangazi University Medical Faculty; 🇹🇷 Eskişehir, Turkey

Kocaeli Üniversitesi University Medical Faculty; 🇹🇷 Kocaeli, Turkey

İzmir Behçet Uz Child Disease Hospital; 🇹🇷 İzmir, Turkey

Kırıkkale University Medical Faculty; 🇹🇷 Kırıkkale, Turkey

Ankara University Medical Faculty; 🇹🇷 Ankara, Turkey

Bursa Yüksek İhtisas Research and Training Hospital; 🇹🇷 Bursa, Turkey

Pamukkale Üniversitesi University Medical Faculty; 🇹🇷 Denizli, Turkey

Çukurova University Medical Faculty; 🇹🇷 Adana, Turkey

Hacettepe Üniversitesi University Medical Faculty; 🇹🇷 Ankara, Turkey

Ankara Dışkapı Child Disease Hospital; 🇹🇷 Ankara, Turkey

Elazığ University Medical Faculty; 🇹🇷 Elazığ, Turkey

İstanbul Kanuni Sultan Süleyman Research and Training Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Şişli Hamidiye Etfal Research and Training Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Ümraniye Research and Training Hospital; 🇹🇷 İstanbul, Turkey

İnönü Üniversitesi University Medical Faculty; 🇹🇷 Malatya, Turkey

Ondokuz Mayıs University Medical Faculty; 🇹🇷 Samsun, Turkey

Karadeniz Teknik University Medical Faculty; 🇹🇷 Trabzon, Turkey