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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02802059
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form by the parents
* Age at inclusion: max. 120 hours after birth
* Functionally mature infant
* Gestational age more than 35th week of development
* Mother's intention to breastfeed the participant
* Readiness of the mother to administer no probiotics additionally to the trial medication
Exclusion Criteria:
* Non-fulfilment of the at least one inclusion criteria
* Lack of propensity/compliance of mother
* 5 min APGAR SCORE less than 5
* 10 min APGAR SCORE less than 8
* pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)
* Any perinatal infection required antibiotic treatment
* Birth weight less than 2000 g
* TORCH-infection of the mother
* HIV-infection of the mother
* Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
120 Hours
Study:
NCT02802059
Study Brief:
Protocol Section:
NCT02802059