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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT04491266
Eligibility Criteria:
Inclusion Criteria:
* otherwise healthy formula fed-neonates
* born at term (\>37 gestational age)
* adequate weight for gestational age
Exclusion Criteria:
* twins,
* infants with history of severe asphyxia,
* meconium aspiration syndrome,
* immunodeficiency,
* congenital infections,
* genetic diseases and chromosomal abnormalities,
* malformations,
* insufficient reliability or presence of conditions that made the patient's compliance with the protocol unlikely,
* infants with any other condition which, in the opinion of the Investigator, is likely to interfere with the ability of the infant to ingest food, or the normal growth and development of the infant, or the evaluation of the infant.
In addition, as maternal exclusion factors:
* history of immune diseases,
* tumors,
* infectious or inflammatory diseases that required antibiotic therapy during pregnancy,
* diabetes,
* gestosis,
* dyslipidemia,
* positive vaginal swab for Group B Streptococcus,
* prolonged rupture of membranes.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Days
Study:
NCT04491266
Study Brief:
Protocol Section:
NCT04491266