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

Abbott Nutrition17 sites in 1 country345 target enrollmentFebruary 2013

ConditionsGI Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: GI Tolerance
Sponsor: Abbott Nutrition
Enrollment: 345
Locations: 17
Primary Endpoint: Physician Perception of Formula Use
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

June 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

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