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 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
NCT ID:
NCT07242950
Eligibility Criteria:
Inclusion criteria for the case group:
* Diagnosed with non-IgE-mediated ARI during the study period,
* Aged less than 26 weeks at the beginning of the study,
* Still breastfeeding,
* Gestational age between 37 and 42 weeks,
* Single birth,
* Birth weight ≥ 2500 g and ≤ 4500 g, and their mothers.
The exclusion criteria for the case group are as follows:
those with a diagnosed chronic or systemic disease, those with neonatal disease or congenital malformation, those who have had an infection or illness requiring hospitalisation during the study period, infants who have never been breastfed and their mothers.
Inclusion criteria for the control group:
* Age less than 26 weeks at the beginning of the study,
* No allergy to food or medication,
* No diagnosis of an atopic disease,
* Still breastfeeding,
* Gestational age between 37 and 42 weeks,
* Single birth,
* Infants with birth weight ≥ 2500 g and ≤ 4500 g and their mothers.
The exclusion criteria for the control group are as follows:
Those with a diagnosed allergy or atopic disease, those with a diagnosed known chronic or systemic disease, those with neonatal disease or congenital malformations, those who have experienced an infection or illness requiring hospitalisation during the study period, infants who have never received breast milk and their mothers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
26 Weeks
Study:
NCT07242950
Study Brief:
Protocol Section:
NCT07242950