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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04208503
Eligibility Criteria:
Inclusion Criteria:
* preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
* in born or admitted to the unit within one week from birth
* randomization within 7 days from birth
* parental consent
Exclusion Criteria:
* preterm delivery \<23 weeks of gestation or \> 32 weeks (estimated by ultrasound)
* major congenital abnormalities
* no parental consent
* medications used after birth: steroids, vasopressors (up to 12 hours after end of treatment)
* positive thyroid stimulating antibodies (TSAb) in the mother
* mothers with thyroid disease treated with antythyroid drugs
* mothers treated with amiodarone
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
12 Weeks
Study:
NCT04208503
Study Brief:
Protocol Section:
NCT04208503