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Not yet recruiting NCT05551975

Preterm Infants Fed a Human Milk Fortifier

No phase Interventional Growth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control Product, Experimental Product 1, Experimental Product 2.
Who it may be relevant to
Registry conditions: Growth. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Other Control Product
    Fed from Study Day 1
  • Other Experimental Product 1
    Fed from Study Day 1
  • Other Experimental Product 2
    Fed from Study Day 1

Primary outcome measures

  • Weight [Time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first]
Secondary outcome measures (9)
  • Length [Time frame: Study Day 1 to Study Day 15 and Study Day 29]
  • Length [Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge]
  • Head Circumference [Time frame: Study Day 1 to Study Day 15 and Study Day 29]
  • Head Circumference (HC) [Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge]
  • Weight [Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge]
  • Weight [Time frame: Study Day 1 to Study Day 15]
  • Stool Characteristics [Time frame: Study Day 1 to Study Day 29]
  • Feeding Intolerance [Time frame: Study Day 1 to Study Day 29]
  • Full Enteral Feeds [Time frame: Study Day 1 to Study Day 29]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 14 centers
  • Banner - University Medical Center — Phoenix
  • UAMS Medical Center — Little Rock
  • Connecticut Children's Medical Center — Hartford
  • South Miami Hospital — Miami
  • AdventHealth — Orlando
  • University of South Florida — Tampa
  • Tufts Medical Center — Boston
  • Children's Mercy Hospital — Kansas City
  • … and 6 more centers

Identifiers

NCT: NCT05551975 · AL46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗