Status:
COMPLETED
Prebiotic in Preterm Infants
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Preterm Infant
Development, Infant
Eligibility:
All Genders
7-10 years
Phase:
NA
Brief Summary
This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the...
Eligibility Criteria
Inclusion
- Preterm infants who meet the following inclusion criteria will be eligible for randomization:
- Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and \>/=26 weeks to 31 6/7 weeks.
- 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.
- Signed consent is obtained by day 10 after birth.
- Mother plans to provide her own milk or consents to use of donor human milk in NICU.
Exclusion
- Infants with the following conditions or situations at the time of randomization will be excluded from the study:
- Subject has known congenital anomalies.
- Administration of enteral clinical product must be initiated by 9 ± 2 days of life (birth date is day of life 0).
- Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
- Steroid use at time of randomization
- Mechanical ventilator dependence.
- \>2 days of antimicrobial use prior to enrollment
- Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
- Mother or infant is currently receiving treatment consistent with HIV therapy.
- Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
- Infant with intraventricular hemorrhage
Key Trial Info
Start Date :
July 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03306316
Start Date
July 4 2018
End Date
December 31 2023
Last Update
February 8 2024
Active Locations (1)
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1
Nationwide Children's Hospital and affiliated NICUs
Columbus, Ohio, United States, 43206