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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT05911893
Eligibility Criteria:
Inclusion Criteria:
* Aged 1-3 years
* BMI for Age Z-score\<-2
* Height-for-age z score\<-2
* Total daily energy intake\<75% of recommended nutrient intake
* The child's guardian is willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
* Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection)
* Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.)
* Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.)
* Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment
* Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study
* Have used high-energy enteral nutrition preparations for the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT05911893
Study Brief:
Protocol Section:
NCT05911893