The Effects of a High-fiber Formula in Children With Failure to Thrive

NCT02819401 | Completed

• 1 other identifier: ANTK1001
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 17

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.

Conditions

GI Tolerance

Outcome Measures

Primary Outcomes (1)

• Physician Perception of Formula Use

  Questionnaire

  Baseline to Month 6

Secondary Outcomes (3)

• 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

Interventions

pediatric formula OTHER

high-fiber enteral formula

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age; 1-10 years (inclusive)
• Children diagnosed as failure-to-thrive(FTT).

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (17)

Ankara Üniversitesi Tıp Fakültesi

Ankara, 06100, Turkey (Türkiye)

Location

Trakya Üniversitesi Tıp Fakültesi

Edirne, 22030, Turkey (Türkiye)

Location

Fırat Üniversitesi Tıp Fakültesi

Elâzığ, 23200, Turkey (Türkiye)

Location

Özel Doğu Anadolu Hastanesi

Elâzığ, Turkey (Türkiye)

Location

Gaziantep Üniversitesi Tıp Fakültesi

Gaziantep, 27070, Turkey (Türkiye)

Location

Memorial Şişli Hastanesi

Istanbul, 34385, Turkey (Türkiye)

Location

Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Location

Dr.Sadi Konuk Eğitim ve Araştırma Hastan

Istanbul, Turkey (Türkiye)

Location

Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi

Izmir, 35100, Turkey (Türkiye)

Location

Behçet Uz Çocuk Hastalıkları Hastanesi

Izmir, Turkey (Türkiye)

Location

İzmir Tepecik Eğitim ve Araştırma Hastanes

Izmir, Turkey (Türkiye)

Location

Erciyes Üniversitesi Tıp Fakültesi

Kayseri̇, 38039, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Tıp Fakültesi

Kocaeli, Turkey (Türkiye)

Location

Konya Üniversitesi Selçuk Tıp Fakültesi

Konya, 42250, Turkey (Türkiye)

Location

Kırıkkale Üniversitesi Tıp Fakültesi

Kırıkkale, Turkey (Türkiye)

Location

Samsun Kadın Doğum ve Çocuk Hastanesi

Samsun, 55070, Turkey (Türkiye)

Location

Ondokuz Mayıs Üniversitesi Tıp Fakültesi

Samsun, 55139, Turkey (Türkiye)

Location

Study Officials

• Aysugul Alptekin, MD

  Abbott Turkey

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: June 30, 2016
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (17)