Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nationwide Children's Hospital
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and \>/=26 weeks to 31 6/7 weeks.
2. Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an informed consent form (ICF). They have also provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
3. Signed consent is obtained by day 10 after birth.
4. Mother plans to provide her own milk or consents to use of donor human milk in NICU.
You may not be if
Infants with the following conditions or situations at the time of randomization will be excluded from the study:
1. Subject has known congenital anomalies.
2. Administration of enteral clinical product must be initiated by 9 ± 2 days of life (birth date is day of life 0).
3. Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
4. Steroid use at time of randomization
5. Mechanical ventilator dependence.
6. \>2 days of antimicrobial use prior to enrollment
7. Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
8. Mother or infant is currently receiving treatment consistent with HIV therapy.
9. Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
