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Clinical Trials in the USA / NCT05551975
Starting soon Not applicable

Preterm Infants Fed a Human Milk Fortifier

NCT05551975 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Nutrition
Phase
Not applicable
Started
2024-09
Last updated
2024-06-28

Condition(s) studied

Growth

Investigational drug(s) / intervention(s)

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)

Trial sites (14)

FacilityCityRegionStatus
Banner - University Medical Center Phoenix Arizona
UAMS Medical Center Little Rock Arkansas
Connecticut Children's Medical Center Hartford Connecticut
South Miami Hospital Miami Florida
AdventHealth Orlando Florida
University of South Florida Tampa Florida
Tufts Medical Center Boston Massachusetts
Children's Mercy Hospital Kansas City Missouri
University of New Mexico Children's Hospital Albuquerque New Mexico
North Shore University Hospital Manhasset New York
Duke University Medical Center Durham North Carolina
The Woman's Hospital of Texas Houston Texas
St. Luke's Baptist Hospital San Antonio Texas
WVU Medicine Children's Hospital Morgantown West Virginia

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Official registry record

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.

View NCT05551975 on ClinicalTrials.gov ↗ ← All trials in the USA