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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT03229967
Eligibility Criteria:
Inclusion Criteria:
1. Newborn humans less than 1 week of age with a birthweight less than 1,500 g, or fetuses with impending delivery and estimated birthweight of less than 1,500 grams. No individuals will be excluded on the basis of sex or ethnicity.
2. Parents can understand and comply with planned study procedures.
3. Parents provide assent/permission prior to any study procedures.
Inclusion criteria mothers:
1\. The mother's of infants meeting the infant inclusion criteria above.
Exclusion Criteria:
1. Diagnosed immunodeficiency disorder.
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agent.
3. Infants whose mothers meet the exclusion criteria below.
Exclusion criteria mothers:
1. Diagnosed immunodeficiency disorder
2. Currently receiving investigational immunomodulatory, probiotic or antiviral agents
3. Lacking the mental capacity (e.g. due to pain, anesthesia, mental impairment) to provide informed consent for themselves or assent for the participation of their infant.
4. Having an infant that meets the infant exclusion criteria.
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
7 Days
Study:
NCT03229967
Study Brief:
Protocol Section:
NCT03229967