Human Milk Concentrating Device to Optimize Mother's Own Milk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-35
SponsorMother's Milk is Best
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Major congenital anomalies
Contraindication to receiving MOM
Feeds not started by 2 days post-birth
Fortification/supplementation not ordered by 5 days post-birth,
Trial design
Design model
Parallel
Treatments tested in this trial
Human Milk Concentration Device
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.
Standard of Care Fortified Feeding
Other interventionMother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: HMC-Concentrated MOMExperimental treatment 1 intervention
Group B: Standard Fortified Feeding (MOM + Fortifier/Formula)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Growth Velocity
Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
Time frame
Birth to 28 days of life or hospital discharge, whichever occurs first2
Serum Phosphate Level
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
Time frame
14 days of lifeSecondary outcomes
1
Feeding Tolerance
Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.
Time frame
Up to 28 days of life or hospital discharge2
Weight Gain Monitoring
Serial assessment of infant weight to evaluate adequacy of growth during the study period.
Time frame
Daily through 28 days of life or discharge3
Feeding Preparation Cost
Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
Time frame
Up to 28 days of life or discharge4
Total Feeding Cost
Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
Time frame
First 28 days of life or until dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mother's Milk is Best
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Weill Medical College of Cornell University
Collaborator
Yale University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: