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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05815433
Eligibility Criteria:
Inclusion Criteria:
* Gestation greater than 37 weeks (full-term)
* Completion of antibiotic protocol for GBS during labour
* Vaginal delivery
* Intending on breastfeeding
* Consent for infant to receive DHM
* Working understanding (proficient in reading and understanding) English
* Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
* In the investigator's opinion, the subject mother understands and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
Exclusion Criteria:
* Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
* No intention to breastfeed
* Receiving extended courses of antibiotics (beyond that of the IAP in labour)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
37 Weeks
Study:
NCT05815433
Study Brief:
Protocol Section:
NCT05815433