Human Milk for Premature Infant Diseases
(M-MILK RCT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a special method of administering human milk, called M-MILK, can help very preterm infants (born before 32 weeks) manage stress, enhance brain development, and improve oral feeding skills. Researchers will compare infants receiving M-MILK with those receiving usual care to determine if this new approach impacts stress and development. The trial suits preterm infants fed human milk, either from their mother or a donor. As an unphased trial, it offers infants a unique opportunity to potentially benefit from innovative feeding methods while contributing to important research.
What prior data suggests that the M-MILK intervention is safe for very preterm infants?
Research has shown that giving very preterm infants small amounts of human milk early on is well-tolerated. This method, called M-MILK, involves gently administering tiny drops of milk to babies starting from their third day of life, guided by the baby's own signals and reactions.
Studies have not reported any serious side effects with M-MILK. It is considered safe because it uses human milk, a natural and standard part of infant care. The milk can come from the baby's mother or be donated, and both sources are generally safe for babies.
In summary, all available evidence suggests that M-MILK does not pose any significant safety risks to very preterm infants. This makes it a promising option for supporting their early development and helping them manage stress.12345Why are researchers excited about this trial?
Researchers are excited about the Multisensory Early Oral Administration of Human Milk (M-MILK) because it offers a unique approach to supporting premature infants by integrating human milk into their early oral care. Unlike traditional methods that focus primarily on nutritional support through feeding tubes, M-MILK introduces small droplets of human milk directly to the infant's mouth multiple times a day, which could stimulate the development of oral feeding skills and digestive readiness. This method leverages the natural benefits of human milk, such as immunological and growth factors, delivered in a way that aligns with the infant’s developmental cues and responses. M-MILK could potentially enhance the transition to full oral feeding, offering a more holistic support system for these vulnerable infants.
What evidence suggests that the M-MILK intervention is effective for improving stress regulation, neurodevelopment, and oral feeding skills in very preterm infants?
This trial will compare the effects of Multisensory Early Oral Administration of Human Milk (M-MILK) with standard care. Research has shown that providing very preterm infants with human milk in a multisensory manner (M-MILK) might be beneficial. Studies suggest that M-MILK can help these infants manage stress better by influencing stress hormones and genes related to stress. This approach may aid brain development and improve feeding skills, which are vital for preterm babies. M-MILK offers sensory experiences that are more beneficial than other methods. Early findings indicate it could be a promising way to support the development of very preterm infants.12367
Who Is on the Research Team?
Thao Griffith, PhD
Principal Investigator
Loyola University Chicago
Are You a Good Fit for This Trial?
This trial is for very preterm infants born at or before 32 weeks of gestation who are receiving mother's own milk and/or donor human milk. It aims to see if a special intervention involving multisensory early oral administration of human milk can help with stress regulation, neurodevelopment, and feeding skills.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
M-MILK intervention starts on day 3 of life and continues until oral feeding initiation, provided up to 4 times a day
Follow-up
Participants are monitored for oral feeding skills and stress regulation up to 36 weeks postmenstrual age
Long-term Follow-up
Evaluation of neurodevelopment and oral feeding skills at 2 months corrected age
What Are the Treatments Tested in This Trial?
Interventions
- Multisensory Early Oral Administration of Human Milk (M-MILK)
Trial Overview
The M-MILK intervention is being tested against the standard care to determine its effectiveness in improving stress response, neurodevelopmental outcomes, and oral feeding abilities in very preterm infants. The study involves measuring cortisol levels, gene methylation related to stress, overall brain development progress, and how well these babies feed orally.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.
Infants in the Control group will receive standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loyola University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Rush University Medical Center
Collaborator
Citations
Multisensory Early Oral Administration of Human Milk (M- ...
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born ...
griffith, thao t
The multisensory early oral administration of human milk (M-MILK) is a promising infant-led early NICU intervention that provides very preterm infants with the ...
Multisensory Early Oral Administration of Human Milk in Preterm ...
We will recruit preterm infants who are born between 22 to 33 weeks gestational age. We will compare the outcomes between the M-MILK and attention control ...
Enhancing Stress Regulation, Neurodevelopment, and ...
M-MILK offers unique advantages in that M-MILK emphasizes multisensory experiences and infant-led interactions, unlike previous interventions, ...
Multisensory stimulation and its effect on breast milk ...
Conclusion: Multisensory stimulation in postpartum mothers of preterm infants caused an increase in the volume of mother's own milk production.
6.
ctv.veeva.com
ctv.veeva.com/study/multisensory-early-oral-administration-of-human-milk-in-preterm-infantsMultisensory Early Oral Administration of Human Milk in ...
This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse ...
7.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41554032/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0nK-FGmcPzruPpJferMpyd8mRld7hsB1ra05TRUDXN6&fc=None&ff=20260120052908&v=2.18.0.post22+67771e2Study Protocol for a Randomized Controlled Trial of ...
M-MILK is an infant-led early NICU intervention beginning on day 3 of life to provide very preterm infants with small droplets of milk orally ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.