Clinical trial NCT02819401: The Effects of a High-fiber Formula in Children With Failure to Thrive
Official title: A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GI Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 345
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with failure to thrive who are receiving a high-fiber enteral formula for supportive treatment as part of the routine healthcare service in Turkey.

Brief summary: The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.


Eligibility criteria: Inclusion Criteria:

* Age; 1-10 years (inclusive)
* Children diagnosed as failure-to-thrive(FTT).
* Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study.

Exclusion Criteria:

* Chronic renal disorder
* Decompensated liver disease
* Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.)
* Any type of malignant disease including leukemia and lymphoma
* Cystic fibrosis
* Short bowel syndrome
* Any type of food allergy or intolerance
* Growth hormone deficiency
* Use of enteral feeding within the last 4 weeks

Primary outcomes:
measure: Physician Perception of Formula Use
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Baseline to Month 1, Month 2, Month 4 and Month 6
measure: Description of Population
timeFrame: Baseline
measure: Weight
timeFrame: Baseline to Month 1, Month 2, Month 4 and Month 6
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi
city: Edirne
country: Turkey
facility: Trakya Üniversitesi Tıp Fakültesi
city: Elazığ
country: Turkey
facility: Fırat Üniversitesi Tıp Fakültesi
city: Elazığ
country: Turkey
facility: Özel Doğu Anadolu Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Üniversitesi Tıp Fakültesi
city: İstanbul
country: Turkey
facility: Memorial Şişli Hastanesi
city: Istanbul
country: Turkey
facility: Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi
city: Istanbul
country: Turkey
facility: Dr.Sadi Konuk Eğitim ve Araştırma Hastan
city: İzmir
country: Turkey
facility: Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi
city: İzmir
country: Turkey
facility: Behçet Uz Çocuk Hastalıkları Hastanesi
city: İzmir
country: Turkey
facility: İzmir Tepecik Eğitim ve Araştırma Hastanes
city: Kayseri̇
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Tıp Fakültesi
city: Konya
country: Turkey
facility: Konya Üniversitesi Selçuk Tıp Fakültesi
city: Kırıkkale
country: Turkey
facility: Kırıkkale Üniversitesi Tıp Fakültesi
city: Samsun
country: Turkey
facility: Samsun Kadın Doğum ve Çocuk Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Study officials:
affiliation: Abbott Turkey
name: Aysugul Alptekin, MD
role: STUDY_CHAIR
References: