TolerUp Enteral Feeding Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-19

Study Completion Date

2020-07-20

Brief Summary

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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

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Conditions

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Gastrointestinal Tolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aysugül Alptekin, MD

Role: STUDY_CHAIR

Abbott Turkey

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Turkey (Türkiye)

Other Identifiers

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DA15

Identifier Type: -

Identifier Source: org_study_id

TolerUp Enteral Feeding Protocol

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Abbott Nutrition

Responsible Party

Principal Investigators

Aysugül Alptekin, MD

Locations

Çukurova University Medical Faculty

Hacettepe Üniversitesi University Medical Faculty

Ankara Dışkapı Child Disease Hospital

Gazi University Medical Faculty

Ankara University Medical Faculty

Bursa Yüksek İhtisas Research and Training Hospital

Pamukkale Üniversitesi University Medical Faculty

Elazığ University Medical Faculty

Eskişehir Osmangazi University Medical Faculty

Koç University Medical Faculty

İstanbul Kanuni Sultan Süleyman Research and Training Hospital

İstanbul Şişli Hamidiye Etfal Research and Training Hospital

İstanbul Ümraniye Research and Training Hospital

İzmir Behçet Uz Child Disease Hospital

Kocaeli Üniversitesi University Medical Faculty

Kırıkkale University Medical Faculty

İnönü Üniversitesi University Medical Faculty

Ondokuz Mayıs University Medical Faculty

Karadeniz Teknik University Medical Faculty

Countries

Other Identifiers

DA15