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Human Milk Concentrating Device for Preterm Infants

This study is looking at a new device called the Human Milk Concentration Device (HMC device). This device helps make a mother's own milk (MOM) more nutritious for premature babies by removing water, so it's more concentrated. This means babies might not need cow's milk-based fortifiers. We want to see if babies fed with MOM concentrated by the HMC device grow as well and have similar mineral levels as babies who receive MOM with standard fortifiers. We'll measure growth up to 28 days or hospital discharge, and phosphate levels at 14 days. You might be able to join if your baby was born between 32 and 35 weeks gestational age, weighs over 1500 grams, and is receiving MOM. The study status is currently unclear.

Study design
This is a randomized study with 310 participants comparing the HMC device to standard feeding practices. Participants will be assigned by chance to one of the two groups.
What's involved
Clinical assessments will be done throughout the study to check your baby's growth, nutrition, and overall health. Routine lab tests will also be performed.
Compensation
Not stated in the trial record.
Follow-up
Your baby's growth will be followed until 28 days of life or hospital discharge, whichever comes first. Serum phosphate levels will be checked at 14 days of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07576972

Human Milk Concentrating Device to Optimize Mother's Own Milk

Not Yet Recruiting
NAAges 32–35InterventionalSupportive care
Mother's Milk is Best
~310 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Human Milk Concentration DeviceStandard of Care Fortified Feeding

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Growth Velocity
Measured over Birth to 28 days of life or hospital discharge, whichever occurs first
+1 more outcome measured

Conditions

Preterm Infant Health
Premature Babies

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Premature infant

NCT07576972

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale University

    New Haven, Connecticutno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sarah Taylor, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Elizabeth Nelson, PhD
[email protected]
2679818066
Email the study team

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Eligibility criteria

Inclusion

Birth at 32 0/7 to 34 5/7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM
Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification/supplementation.
Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.

Exclusion

Major congenital anomalies
Contraindication to receiving MOM
Feeds not started by 2 days post-birth
Fortification/supplementation not ordered by 5 days post-birth,
Inadequate MOM for concentration/fortification within 5 days post-birth
Expected transfer to another hospital
Expected hospital discharge within 14 days post-birth
Enrollment in another intervention study with an intervention that could affect infant growth or mineral status
Infant with contraindications for use of the HMC device

What this trial measures

  • Growth VelocityBirth to 28 days of life or hospital discharge, whichever occurs first

    Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.

  • Serum Phosphate Level14 days of life

    Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.