Enteral Formula Tolerance in Pediatric Patients

Nestlé

Status: Completed

Conditions: Enteral Nutrition

Treatments: Other: Enteral Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02779335

15.09.US.HCN

Details and patient eligibility

About

The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

Full description

In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.

Enrollment: 22 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1 - 13 years of age
• Currently tolerating enteral feeding
• Has enteral access
• Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
• Having obtained his/her and/or his/her legal representative's informed consent

Exclusion criteria

• Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
• Lack of enteral access
• Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
• Judged to be at risk for poor compliance to the study protocol
• Lack of informed consent
• Currently participating in another conflicting clinical trial

Trial design

22 participants in 1 patient group

Enteral formula tube feeding

Other group

Description:

Enteral fed children, ages 1-13, with establish enteral feeding access

Treatment:

Other: Enteral Formula