Preterm Infants Fed a Human Milk Fortifier

Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Growth
• Intervention / Treatment: Other: Control Product; Other: Experimental Product 1; Other: Experimental Product 2

• Study Type: Interventional
• Enrollment (Estimated): 321
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen S DeLuca, MS, RDN, LDN; Phone Number: 614-645-5455; Email: kristen.deluca@abbott.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner - University Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • UAMS Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Florida
    • Miami, Florida, United States, 33143
      • South Miami Hospital
    • Orlando, Florida, United States, 32803
      • AdventHealth
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Children's Hospital
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas
    • San Antonio, Texas, United States, 78229
      • St. Luke's Baptist Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • WVU Medicine Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Product; Control Human Milk Fortifier added to human milk feedings	Other: Control Product; Fed from Study Day 1
Experimental: Product 1; Study Human Milk Fortifier added to human milk feedings	Other: Experimental Product 1; Fed from Study Day 1
Experimental: Product 2; Study Human Milk Fortifier added to human milk feedings	Other: Experimental Product 2; Fed from Study Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight gain per day	Study Day 1 to Study Day 29 or Hospital Discharge if first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Percent bloody, black, watery, or hard stools	Study Day 1 to Study Day 29
Full Enteral Feeds	Days to achieve full enteral feeds	Study Day 1 to Study Day 29
Length	Length gains per week	Study Day 1 to Study Day 15 and Study Day 29
Length	Attained length in cm	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Head Circumference	Head circumference gains per week	Study Day 1 to Study Day 15 and Study Day 29
Head Circumference (HC)	Attained HC in cm	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight	Attained weight in grams	Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight	Weight gain per day	Study Day 1 to Study Day 15
Feeding Intolerance	Percent periods NPO, feedings withheld due to gastrointestinal intolerance	Study Day 1 to Study Day 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Chemistries	Electrolytes, minerals, BUN, alkaline phosphatase	Study Day 1 to Study Day 29
Medications	Medication usage including frequency and reason for use	Study Day 1 to Study Day 29
Length of Stay	Number of days in hospital	From birth until Discharge, typically 60 days
Adverse Events	Number of participants with adverse events (AEs) and concurrent expected events	Study Day 1 until Discharge, typically 60 days
Stool Sample	Characterization of microbiota, immunity	Study Day 1 to Study Day 29
Blood Sample for Immunity/Inflammation	Cytokines	Study Day 1 to Study Day 29

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Elizabeth Reverri, PhD, MS, RD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AL46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No