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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT04541095
Eligibility Criteria:
Inclusion Criteria:
* gestational age between 24 and 32 weeks of gestation at enrollment,
* birth weight greater than 750 grams,
* singleton or twin birth (no triplet or higher),
* fraction of inspired oxygen lower than 0.60 at enrollment,
* feasible enteral feeding,
* cardiovascular stable condition,
* informed consent form signed by at least one parent or legal guardian.
Exclusion Criteria:
* congenital malformations, genetic, metabolic and endocrine disorders,
* suspicious infection at enrollment,
* intrauterine growth restriction (\<10th centile) at enrollment,
* maternal diabetes requiring insulin therapy,
* neonatal asphyxia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
32 Weeks
Study:
NCT04541095
Study Brief:
Protocol Section:
NCT04541095