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 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT02715895
Eligibility Criteria:
Inclusion Criteria:
* 1 to 2 months-old term infants (gestational age ≥37 weeks) checked-up in child care department
* Gender not limited
* Though completely understanding the importance of breast milk feeding, subjects' mothers cann't continue to give breast milk feeding owing to their own problems, and have to feed infants with foumula milk only
* Legal guardians of subjects know the objective of this study and get the tested formula milk for free, then volunteer to participate in the study and sign an informed consent
Exclusion Criteria:
* Infants' mothers suffered from infectious diseases during pregnancy
* Subjects suffered from basic diseases (such as congenital heart disease and genetic metabolic diseases) and congenital deformity
* Brain damage caused by a variety of factors such as HIE, intraventricular hemorrhage, hypoglycemia
* Small for gestational age
* Subjects cann't get full enteral feeding, such as NEC
* Subjects allergic to cow's milk protein
* Subjects used antibiotics before inclusion
* Subjects participate in other clinical trials before inclusion or during this trial
Drop-out Criteria:
* Subjects in violation of this trial plan (using the other brand formula or not according to the plan)
* Loss of follow-up
* Withdrawing the informed consent or asked to quit on their own
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
8 Weeks
Study:
NCT02715895
Study Brief:
Protocol Section:
NCT02715895