Control ProductExperimental Product 1Experimental Product 2
Control Product: Fed from Study Day 1
Experimental Product 1: Fed from Study Day 1
Experimental Product 2: Fed from Study Day 1
Study summary
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Birth weight between 700 g-1500 g.
* ≤ 32 weeks and 0 days GA at birth.
* Participant has been classified as appropriate for GA (AGA).
* Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)
* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized.
* Parent(s) agrees to allow infant to receive both human milk and study HMF.
* Singleton or twin births only.
* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion Criteria:
* Enteral feeding of preterm infant formula or HMF for \> 7 days.
* Expected to be transferred to another facility within 30 days of randomization.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5-minute APGAR ≤ 4.
* Receiving systemic steroids at time of randomization.
* Receiving probiotics at time of randomization.
* Grade Ill or IV PVH/IVH.
* Dependent on invasive ventilation at time of randomization.
* Maternal incapacity.
* Mother or infant is currently receiving treatment consistent with HIV therapy.
* Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.
* Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.
* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life.
* Confirmed NEC (Bell's Stage II or III).
* Confirmed current sepsis.
* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
* Participation in another study that has not been approved as a concomitant study by AN.
* Participant has an allergy or intolerance to any ingredient in study fortifier.
Primary outcome measure(s)
Weight — Study Day 1 to Study Day 29 or Hospital Discharge if first Weight gain per day
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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