Gastrointestinal Tolerance Clinical Trial
Official title:
A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
NCT number | NCT03648255 |
Other study ID # | DA15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 19, 2018 |
Est. completion date | July 20, 2020 |
Verified date | November 2020 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | July 20, 2020 |
Est. primary completion date | July 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Çukurova University Medical Faculty | Adana | |
Turkey | Ankara Diskapi Child Disease Hospital | Ankara | |
Turkey | Ankara University Medical Faculty | Ankara | |
Turkey | Gazi University Medical Faculty | Ankara | |
Turkey | Hacettepe Üniversitesi University Medical Faculty | Ankara | |
Turkey | Bursa Yüksek Ihtisas Research and Training Hospital | Bursa | |
Turkey | Pamukkale Üniversitesi University Medical Faculty | Denizli | |
Turkey | Elazig University Medical Faculty | Elazig | |
Turkey | Eskisehir Osmangazi University Medical Faculty | Eskisehir | |
Turkey | Istanbul Kanuni Sultan Süleyman Research and Training Hospital | Istanbul | |
Turkey | Istanbul Sisli Hamidiye Etfal Research and Training Hospital | Istanbul | |
Turkey | Istanbul Ümraniye Research and Training Hospital | Istanbul | |
Turkey | Koç University Medical Faculty | Istanbul | |
Turkey | Izmir Behçet Uz Child Disease Hospital | Izmir | |
Turkey | Kirikkale University Medical Faculty | Kirikkale | |
Turkey | Kocaeli Üniversitesi University Medical Faculty | Kocaeli | |
Turkey | Inönü Üniversitesi University Medical Faculty | Malatya | |
Turkey | Ondokuz Mayis University Medical Faculty | Samsun | |
Turkey | Karadeniz Teknik University Medical Faculty | Trabzon |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastro-Intestinal Tolerance | healthcare professional assessed | Baseline to 6 months | |
Secondary | Anthropometrics | change in weight from baseline measurement | Baseline to 6 months | |
Secondary | Care Giver Satisfaction of Enteral Product | survey administered by healthcare professional | Baseline to 6 months |
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