Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT02779335
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
13 Years
Study:
NCT02779335
Study Brief:
Protocol Section:
NCT02779335