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
Sponsor study identifier
observational
345
1 country
17
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)March 18, 2016
Actual (reported)June 30, 2016
Actual (reported)Physician Perception of Formula Use
Questionnaire
Baseline to Month 6
Gastrointestinal Tolerance
Baseline to Month 1, Month 2, Month 4 and Month 6
Description of Population
Baseline
Weight
Baseline to Month 1, Month 2, Month 4 and Month 6
high-fiber enteral formula
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Ankara Üniversitesi Tıp Fakültesi
Ankara, 06100, Turkey (Türkiye)
Trakya Üniversitesi Tıp Fakültesi
Edirne, 22030, Turkey (Türkiye)
Fırat Üniversitesi Tıp Fakültesi
Elâzığ, 23200, Turkey (Türkiye)
Özel Doğu Anadolu Hastanesi
Elâzığ, Turkey (Türkiye)
Gaziantep Üniversitesi Tıp Fakültesi
Gaziantep, 27070, Turkey (Türkiye)
Memorial Şişli Hastanesi
Istanbul, 34385, Turkey (Türkiye)
Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Aysugul Alptekin, MD
Abbott Turkey
345 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2016
First Posted
June 30, 2016
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Dr.Sadi Konuk Eğitim ve Araştırma Hastan
Istanbul, Turkey (Türkiye)
Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi
Izmir, 35100, Turkey (Türkiye)
Behçet Uz Çocuk Hastalıkları Hastanesi
Izmir, Turkey (Türkiye)
İzmir Tepecik Eğitim ve Araştırma Hastanes
Izmir, Turkey (Türkiye)
Erciyes Üniversitesi Tıp Fakültesi
Kayseri̇, 38039, Turkey (Türkiye)
Kırıkkale Üniversitesi Tıp Fakültesi
Kirikkale, Turkey (Türkiye)
Kocaeli Üniversitesi Tıp Fakültesi
Kocaeli, Turkey (Türkiye)
Konya Üniversitesi Selçuk Tıp Fakültesi
Konya, 42250, Turkey (Türkiye)
Samsun Kadın Doğum ve Çocuk Hastanesi
Samsun, 55070, Turkey (Türkiye)
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun, 55139, Turkey (Türkiye)
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
June 30, 2016
Record last verified: 2016-06
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Source: ClinicalTrials.gov.
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