Preterm Infants Fed a Human Milk Fortifier

Launched by ABBOTT NUTRITION · Sep 20, 2022

Keywords

ClinConnect Summary

This clinical trial is designed to study how well a special product called a human milk fortifier (HMF) helps preterm infants grow. The trial will look at whether feeding this fortifier, along with human milk, is safe and beneficial for babies who were born early. It will include babies who weigh between 700 grams and 1500 grams at birth and who are less than 32 weeks old. To participate, the baby's mother must agree to provide human milk during the study, and the baby must be fed human milk starting within 21 days of birth.

To be eligible, babies must not have serious health issues that could affect their growth, and they must not have been fed preterm infant formula or HMF for more than 7 days. Participants will not be recruited yet, but once the study begins, families can expect close monitoring of the baby's growth and reactions to the fortifier. It's important to know that certain health conditions or treatments may exclude some babies from participating, and the study will follow strict guidelines to keep everyone safe.

Gender

ALL

Eligibility criteria

• 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.