Preterm Infants Fed a Human Milk Fortifier

Starting soon · Not applicable

Conditions studied: Growth

In brief

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).

Key facts

Study ID

NCT05551975

Run by

Abbott Nutrition

People needed

321

Starts

2024-09-01

Expected to finish

2028-01-01

Last updated by the study team

2024-06-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.