Clinical trial NCT03648255: TolerUp Enteral Feeding Protocol
Official title: A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 133
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastro-Intestinal Tolerance
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Anthropometrics
timeFrame: Baseline to 6 months
measure: Care Giver Satisfaction of Enteral Product
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Dışkapı Child Disease Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Research and Training Hospital
city: Denizli
country: Turkey
facility: Pamukkale Üniversitesi University Medical Faculty
city: Elazığ
country: Turkey
facility: Elazığ University Medical Faculty
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Koç University Medical Faculty
city: İstanbul
country: Turkey
facility: İstanbul Kanuni Sultan Süleyman Research and Training Hospital
city: İstanbul
country: Turkey
facility: İstanbul Şişli Hamidiye Etfal Research and Training Hospital
city: İstanbul
country: Turkey
facility: İstanbul Ümraniye Research and Training Hospital
city: İzmir
country: Turkey
facility: İzmir Behçet Uz Child Disease Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi University Medical Faculty
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Medical Faculty
city: Malatya
country: Turkey
facility: İnönü Üniversitesi University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
Study officials:
affiliation: Abbott Turkey
name: Aysugül Alptekin, MD
role: STUDY_CHAIR
References: