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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03822104
Eligibility Criteria:
Inclusion Criteria:
1. Very preterm infants born between gestational age 26 + 0 and 30 + 6 weeks (from the first day of the mother's last menstrual period and/or based on fetal ultrasound)
2. DM is given at the unit when MM is absent (or insufficient in amount)
3. Infants judged by the attending physician to be in need of nutrient fortification, as added in the form of HMF to MM and/or DM
4. Signed parental consent
Exclusion Criteria:
1. Major congenital anomalies and birth defects
2. Infants who have had gastrointestinal surgery prior to randomization
3. Infants who have received IF prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
3 Weeks
Study:
NCT03822104
Study Brief:
Protocol Section:
NCT03822104