Infant DevelopmentM-MILKNCT06230848

Multisensory Early Oral Administration of Human Milk in Preterm Infants

A study testing Multisensory Early Oral Administration of Human Milk (M-MILK) in people with Infant Development and Stress, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 0 years to 1 year
Conditions the study is for: Infant Development, Stress
What is being tested?: Multisensory Early Oral Administration of Human Milk (M-MILK)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2023to 23 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 years to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk.

Who cannot join

receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV

Trial locations and contacts

1 site in 1 country.

United States1 site

Loyola University Chicago
Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: Multisensory Early Oral Administration of Human Milk in Preterm Infants to Attenuate Early Life Toxic Stress on Epigenetic Modifications and Dysbiosis: Randomized Controlled Trial Pilot Study

The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation. 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 effects of early life toxic stress in preterm infants.

Conditions: Infant Development, Stress
Being tested: Multisensory Early Oral Administration of Human Milk (M-MILK)
Keywords: stress, preterm infants, epigenetics, gut microbiome, parent-infant relationship

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multisensory Early Oral Administration of Human Milk (M-MILK)Other
M-MILK is implemented starting on day 3 of life, after every hands-on care, during the beginning of a full gavage feeding. 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 nurses or parents.

Study groups in NCT06230848
Study group	Role	What they receive
Control	No intervention	Infants in the control group will receive standard of care.
M-MILK	Experimental	Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care. Receives: Other: Multisensory Early Oral Administration of Human Milk (M-MILK)

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Intervention
The count of participants who receive M-MILK in at least 50% of their scheduled M-MILK administrations. MILK will be considered feasible if M-MILK is implemented by nurses or parents after every hands-on care and during the beginning of a full gavage feeding at least 50% of the time.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Acceptability of Intervention
The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Retention
Retention will be described by the number of post-discharge follow-up surveys completed.
Measured: 2 months corrected age
The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for scarf sign ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for motor development \& vigor ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for popliteal angle ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for alertness and orientation ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for irritability ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for quality of cry ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for percent sleep ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Early Feeding Skill Assessment Score
EFS has 22 items (32-50 weeks PMA), summary scores, 5 subscales: respiratory regulation (range 5 - 15), oral-motor functioning (range 4 - 12), swallowing coordination (range 4 - 12), engagement (range 2 - 6), \& physiologic stability (range 4 - 12), where higher scores indicate better oral feeding skill development. The total score is the sum of the subscales and ranges from 19-57.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Secondary outcomes (5)

Parent Stressor Scale: NICU Score
Scores range from 1 to 5, where higher scores indicate greater parental stress..
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Parent Discharge Readiness Score
Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Breastmilk Pumping Rate
The percentage of mothers who report breastmilk pumping at discharge.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Breastfeeding Rate
The percentage of mothers who report breastfeeding at discharge.
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Maternal Edinburgh Postnatal Depression Scale Score
Scores range from 0 to 30, where higher scores indicate greater depressive symptoms
Measured: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202323 Oct 2024

First posted30 Jan 2024
Study start23 Oct 2023
Primary completion23 Oct 2024
Study completion23 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infant DevelopmentStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06230848
Sponsor's protocol ID: 217411
Acronym: M-MILK
Status last verified: Dec 2025
First submitted: 5 Jan 2024
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infant Development trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multisensory Early Oral Administration of Human Milk in Preterm Infants to Attenuate Early Life Toxic Stress on Epigenetic Modifications and Dysbiosis: Randomized Controlled Trial Pilot Study
ClinicalTrials.gov ID: NCT06230848
Acronym / sponsor ID: M-MILK / 217411
Conditions: Infant Development, Stress
Keywords: stress, preterm infants, epigenetics, gut microbiome, parent-infant relationship
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Study start: 23 Oct 2023 (actual)
Primary completion: 23 Oct 2024 (actual)
Study completion: 23 Oct 2024 (actual)
First posted: 30 Jan 2024 (actual)
Results: Posted 8 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Infants in the control group will receive standard of care.
M-MILK	Experimental	Other: Multisensory Early Oral Administration of Human Milk (M-MILK)Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.

Who may qualify

Ages: 0 years to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

born between 22 to 34 weeks gestational age and receiving mother's own milk and/or donor milk.

Key exclusion criteria (1 listed)

receiving only formula, oral cavity defects, gastrointestinal defects, chromosomal abnormalities, severe cardiac defects that require surgery, or intraventricular hemorrhage grade III or IV

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
Multisensory Early Oral Administration of Human Milk (M-MILK)M-MILK is implemented starting on day 3 of life, after every hands-on care, during the beginning of a full gavage feeding. 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 nurses or parents.	Other	M-MILK

Primary outcome

Feasibility of Intervention
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The count of participants who receive M-MILK in at least 50% of their scheduled M-MILK administrations. MILK will be considered feasible if M-MILK is implemented by nurses or parents after every hands-on care and during the beginning of a full gavage feeding at least 50% of the time.
Acceptability of Intervention
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.
Retention
Time frame: 2 months corrected age
Retention will be described by the number of post-discharge follow-up surveys completed.
The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for scarf sign ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for motor development \& vigor ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for popliteal angle ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for alertness and orientation ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for irritability ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for quality of cry ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
The Neurobehavioral Assessment of the Preterm Infants (NAPI, 73 items, 32-37 weeks PMA): cluster score for percent sleep ranges from 0-100, where higher scores indicate better neurodevelopmental performance.
Early Feeding Skill Assessment Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
EFS has 22 items (32-50 weeks PMA), summary scores, 5 subscales: respiratory regulation (range 5 - 15), oral-motor functioning (range 4 - 12), swallowing coordination (range 4 - 12), engagement (range 2 - 6), \& physiologic stability (range 4 - 12), where higher scores indicate better oral feeding skill development. The total score is the sum of the subscales and ranges from 19-57.

5 secondary outcomes

Parent Stressor Scale: NICU Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Parent Discharge Readiness Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Breastmilk Pumping Rate
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Breastfeeding Rate
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Maternal Edinburgh Postnatal Depression Scale Score
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Results and safety

Results posted to the registry on 8 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Attention Control	4	4
M-MILK	10	7

Primary outcome: Feasibility of Intervention

Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.. Count of participants. Unit: Participants

Measure	Attention Control n = 0	M-MILK n = 10
Value	0	7

Population analysed: Only the intervention arm is assessed for feasibility.

Primary outcome: Acceptability of Intervention

Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.. Count of participants. Unit: Participants

Measure	Attention Control n = 0	M-MILK n = 5
Value	0	5

Population analysed: Reported by the parent in the study exit survey. Only parents in the M-MILK group were asked about the intervention. Two parents did not complete the acceptability survey.

Primary outcome: Retention

Time frame: 2 months corrected age. Count of participants. Unit: Participants

Measure	Control n = 4	M-MILK n = 10
Value	4	7

Primary outcome: The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score

Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Attention Control n = 4	M-MILK n = 7
Value	66.7 (66.7 to 66.7)	66.7 (66.7 to 66.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were evaluated from randomization to hospital discharge, which is typically 10 to 16 weeks from birth.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Attention Control	0 of 4 (0%)	0 of 4 (0%)	0 of 4
M-MILK	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multisensory Early Oral Administration of Human Milk (M-MILK) in people with Infant Development and Stress, run by Loyola University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jan 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?

Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention (time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06230848.

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 Jan 2026.