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NCT05551975 | Not yet recruiting | Growth

Preterm Infants Fed a Human Milk Fortifier
Sponsor:

Abbott Nutrition

Brief 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).

Condition or disease

Growth

Intervention/treatment

Control Product

Experimental Product 1

Experimental Product 2

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 321 participants
Masking : Quadruple
Primary Purpose : Other
Official Title : Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier
Actual Study Start Date : September 2024
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028
Arm Intervention/treatment

Active Comparator: Control Product

Control Human Milk Fortifier added to human milk feedings

Other: Control Product

Experimental: Product 1

Study Human Milk Fortifier added to human milk feedings

Other: Experimental Product 1

Experimental: Product 2

Study Human Milk Fortifier added to human milk feedings

Other: Experimental Product 2
Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Preterm Infants Fed a Human Milk Fortifier

Location Details

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Preterm Infants Fed a Human Milk Fortifier

How to Participate

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