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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT05744193
Eligibility Criteria:
Inclusion Criteria:
* Clinically and metabolically stable
* Birth weight 700 g to less than or equal to 1,250 g
* Appropriate birth weight for gestational age
* 24 0/7 to 32 0/7 weeks' gestational age at birth
* Exclusively fed human milk
* Signed informed consent and authorization to use and/or disclose PHI
Exclusion Criteria:
* Metabolic or chronic disease
* 5-minute Apgar score \<4
* Major surgery
* Ventilator dependent
* Fluid restriction
* Grade III or IV intraventricular hemorrhage (IVH)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
168 Days
Maximum Age:
224 Days
Study:
NCT05744193
Study Brief:
Protocol Section:
NCT05744193