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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00865150
Eligibility Criteria:
Inclusion Criteria
* Documentation of informed consent
* Inborn
* Less than or equal to twenty four (24) hours of age
* Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
* If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
* No known major anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
Exclusion Criteria
* Outborn (transferred for intensive care from another hospital)
* Greater than twenty four (24) hours of age
* Gestational age \< 23 weeks or \> 31 weeks
* Any known major congenital anomalies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
23 Weeks
Maximum Age:
31 Weeks
Study:
NCT00865150
Study Brief:
Protocol Section:
NCT00865150