A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
| Registry | NCT03648255 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 133 (Actual) |
| Sponsor | Abbott Nutrition (Industry) |
| Conditions | Gastrointestinal Tolerance |
| Dates | start 2018-02-19, primary completion 2020-07-20, completion 2020-07-20, first posted 2018-08-27, last updated 2020-11-03 |
| Locations | 19 sites in Turkey (Türkiye) |
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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.
Sex: All, ages: 1 Year to 12 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Çukurova University Medical Faculty | Adana | Turkey (Türkiye) | |
| Hacettepe Üniversitesi University Medical Faculty | Ankara | Turkey (Türkiye) | |
| Ankara Dışkapı Child Disease Hospital | Ankara | Turkey (Türkiye) | |
| Gazi University Medical Faculty | Ankara | Turkey (Türkiye) | |
| Ankara University Medical Faculty | Ankara | Turkey (Türkiye) | |
| Bursa Yüksek İhtisas Research and Training Hospital | Bursa | Turkey (Türkiye) | |
| Pamukkale Üniversitesi University Medical Faculty | Denizli | Turkey (Türkiye) | |
| Elazığ University Medical Faculty | Elâzığ | Turkey (Türkiye) | |
| Eskişehir Osmangazi University Medical Faculty | Eskişehir | Turkey (Türkiye) | |
| Koç University Medical Faculty | Istanbul | Turkey (Türkiye) | |
| İstanbul Kanuni Sultan Süleyman Research and Training Hospital | Istanbul | Turkey (Türkiye) | |
| İstanbul Şişli Hamidiye Etfal Research and Training Hospital | Istanbul | Turkey (Türkiye) | |
| İstanbul Ümraniye Research and Training Hospital | Istanbul | Turkey (Türkiye) | |
| İzmir Behçet Uz Child Disease Hospital | Izmir | Turkey (Türkiye) | |
| Kırıkkale University Medical Faculty | Kirikkale | Turkey (Türkiye) | |
| Kocaeli Üniversitesi University Medical Faculty | Kocaeli | Turkey (Türkiye) | |
| İnönü Üniversitesi University Medical Faculty | Malatya | Turkey (Türkiye) | |
| Ondokuz Mayıs University Medical Faculty | Samsun | Turkey (Türkiye) | |
| Karadeniz Teknik University Medical Faculty | Trabzon | Turkey (Türkiye) |