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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05258656
Eligibility Criteria:
Inclusion Criteria:
* Parent/guardian(s) must understand and provide informed consent
* Infant \<26 weeks of age at enrollment
* Willing to be randomized to either intervention or control
* In good general health as evidenced by medical history
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Child assigned male or female sex at birth
Exclusion Criteria:
* Infant completed less than 28 weeks gestation
* Co-morbid medical diagnoses that would prevent caregivers from initiating solid foods per protocol, such as dysphagia, chronic aspiration, malformations, etc.
* Co-morbid medical diagnoses that would require specialized diet/nutritional needs, such as congenital heart disease, genetic/metabolic disorders, malignancy, etc.
* Caregivers who express unwillingness to introduce peanut, milk, egg, or cashew
* Caregivers who cannot provide informed consent in English or Spanish
* Parents planning to move away from study sites before child is 12 months of age
* Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study
* Infant with a sibling enrolled in the study
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
26 Weeks
Study:
NCT05258656
Study Brief:
Protocol Section:
NCT05258656