Preterm Infant HealthNEOMOMNCT07576972
Human Milk Concentrating Device to Optimize Mother's Own Milk
A study testing Human Milk Concentration Device in people with Preterm Infant Health and Premature Babies, run by Mother's Milk is Best at 1 site in United States.
Trial summary
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based… Read more about this study
- Who is it for?
- Ages 32 to 35 weeks
- Conditions the study is for
- Preterm Infant Health, Premature Babies
- What is being tested?
- Human Milk Concentration Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.
The primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.
Secondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.
Read the detailed description
Preterm infants often require nutritional supplementation to support adequate growth and bone mineralization during hospitalization. Current standard of care commonly involves the addition of cow's milk-based fortifiers or formula to mother's own milk (MOM), which may introduce variability in feeding practices, added cost, and exposure to non-human milk components.
This study evaluates a human milk concentration (HMC) device designed to increase the nutrient density of MOM through passive water removal using forward osmosis. The device enables concentration of MOM without the addition of bovine-derived products and is intended to integrate into existing neonatal intensive care unit (NICU) feeding workflows.
The study is a randomized, controlled, non-inferiority trial conducted in preterm infants receiving enteral nutrition in the NICU. Participants are assigned to receive either MOM concentrated using the HMC device or standard of care feeding consisting of MOM with supplementation per institutional practice. Feeding preparation and administration are performed according to site-specific protocols.
Clinical assessments are conducted throughout the study period to evaluate infant growth, nutritional status, and overall clinical stability. Safety monitoring includes routine clinical evaluations and laboratory assessments consistent with standard NICU care. In addition, data are collected to assess resource utilization and costs associated with feeding preparation and overall care during hospitalization.
The goal of this study is to generate evidence on whether concentrating MOM using the HMC device can provide a clinically comparable alternative to standard supplementation practices while potentially reducing reliance on bovine-derived products and impacting healthcare resource utilization.
- Conditions
- Preterm Infant Health, Premature Babies
- Being tested
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Keywords
- Human Milk Concentration, NICU Feeding, Neonatal nutrition, Mother's on Milk, Human Milk, Preterm infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk Concentration DeviceDevice
A sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier.
Standard of Care Fortified FeedingOther
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
| Study group | Role | What they receive |
|---|---|---|
| HMC-Concentrated MOM | Experimental | Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers. Receives: Device: Human Milk Concentration Device |
| Standard Fortified Feeding (MOM + Fortifier/Formula) | Active comparator | Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care. Receives: Other: Standard of Care Fortified Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Velocity
Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
Measured: Birth to 28 days of life or hospital discharge, whichever occurs first
Serum Phosphate Level
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
Measured: 14 days of life
Secondary outcomes (6)
Feeding Tolerance
Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.
Measured: Up to 28 days of life or hospital discharge
Weight Gain Monitoring
Serial assessment of infant weight to evaluate adequacy of growth during the study period.
Measured: Daily through 28 days of life or discharge
Feeding Preparation Cost
Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
Measured: Up to 28 days of life or discharge
Total Feeding Cost
Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
Measured: First 28 days of life or until discharge
Length of Stay
Duration of hospitalization in the NICU.
Measured: From birth to hospital discharge (up to 10 weeks)
Total NICU cost of care
Total hospital costs incurred during NICU stay, including all resources utilized.
Measured: From birth to hospital discharge (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion14 Mar 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mother's Milk is Best
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center, Weill Medical College of Cornell University, Yale University
- Responsible party
- Sponsor
- Investigators
- Sarah Taylor, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576972
- Sponsor's protocol ID
- MMIB-NEOMOM-2000042290
- Other IDs
- R44HD110306
- Acronym
- NEOMOM
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD Description: De-identified individual participant data underlying the results reported in this study, including baseline characteristics and outcome measures, may be shared. Access Criteria: Data will be made available to qualified researchers upon reasonable request, subject to review and approval by the study sponsor. Access will require a data use agreement and must comply with applicable privacy and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk
- ClinicalTrials.gov ID
- NCT07576972
- Acronym / sponsor ID
- NEOMOM / MMIB-NEOMOM-2000042290
- Conditions
- Preterm Infant Health, Premature Babies
- Keywords
- Human Milk Concentration, NICU Feeding, Neonatal nutrition, Mother's on Milk, Human Milk, Preterm infants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Mother's Milk is BestIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center, Weill Medical College of Cornell University, Yale University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.
The primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.
Secondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.
Detailed description
Preterm infants often require nutritional supplementation to support adequate growth and bone mineralization during hospitalization. Current standard of care commonly involves the addition of cow's milk-based fortifiers or formula to mother's own milk (MOM), which may introduce variability in feeding practices, added cost, and exposure to non-human milk components.
This study evaluates a human milk concentration (HMC) device designed to increase the nutrient density of MOM through passive water removal using forward osmosis. The device enables concentration of MOM without the addition of bovine-derived products and is intended to integrate into existing neonatal intensive care unit (NICU) feeding workflows.
The study is a randomized, controlled, non-inferiority trial conducted in preterm infants receiving enteral nutrition in the NICU. Participants are assigned to receive either MOM concentrated using the HMC device or standard of care feeding consisting of MOM with supplementation per institutional practice. Feeding preparation and administration are performed according to site-specific protocols.
Clinical assessments are conducted throughout the study period to evaluate infant growth, nutritional status, and overall clinical stability. Safety monitoring includes routine clinical evaluations and laboratory assessments consistent with standard NICU care. In addition, data are collected to assess resource utilization and costs associated with feeding preparation and overall care during hospitalization.
The goal of this study is to generate evidence on whether concentrating MOM using the HMC device can provide a clinically comparable alternative to standard supplementation practices while potentially reducing reliance on bovine-derived products and impacting healthcare resource utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMC-Concentrated MOM | Experimental | Device: Human Milk Concentration DevicePreterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers. |
| Standard Fortified Feeding (MOM + Fortifier/Formula) | Active comparator | Other: Standard of Care Fortified FeedingPreterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care. |
Who may qualify
- Ages
- 32 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Milk Concentration DeviceA sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier. | Device | HMC-Concentrated MOM |
| Standard of Care Fortified FeedingMother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care. | Other | Standard Fortified Feeding (MOM + Fortifier/Formula) |
Primary outcome
Growth Velocity
Time frame: Birth 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 Level
Time frame: 14 days of life
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
6 secondary outcomes
Feeding Tolerance
Time frame: Up to 28 days of life or hospital discharge
Weight Gain Monitoring
Time frame: Daily through 28 days of life or discharge
Feeding Preparation Cost
Time frame: Up to 28 days of life or discharge
Total Feeding Cost
Time frame: First 28 days of life or until discharge
Length of Stay
Time frame: From birth to hospital discharge (up to 10 weeks)
Total NICU cost of care
Time frame: From birth to hospital discharge (up to 10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. IPD Description: De-identified individual participant data underlying the results reported in this study, including baseline characteristics and outcome measures, may be shared. Access Criteria: Data will be made available to qualified researchers upon reasonable request, subject to review and approval by the study sponsor. Access will require a data use agreement and must comply with applicable privacy and regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Taylor, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Concentration Device in people with Preterm Infant Health and Premature Babies, run by Mother's Milk is Best at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Nelson, PhD (2679818066, enelson@mmib.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth Velocity (time frame: Birth to 28 days of life or hospital discharge, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.