Trial Outcomes & Findings for Multisensory Early Oral Administration of Human Milk in Preterm Infants (NCT NCT06230848)

NCT ID: NCT06230848

Last Updated: 2026-01-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
• Results posted on: 2026-01-08

Participant Flow

Participant milestones

Measure	Attention Control Infants in the attention control group will receive standard of care.	M-MILK Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Overall Study STARTED	4	10
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline measure was unavailable for one participant

Baseline characteristics by cohort

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=10 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.	Total n=14 Participants Total of all reporting groups
Age, Continuous	30.5 weeks n=4 Participants	27 weeks n=10 Participants	27 weeks n=14 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	7 Participants n=10 Participants	8 Participants n=14 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	3 Participants n=10 Participants	6 Participants n=14 Participants
Race/Ethnicity, Customized Non-Hispanic Black	0 Participants n=4 Participants	4 Participants n=10 Participants	4 Participants n=14 Participants
Race/Ethnicity, Customized Non-Hispanic White	2 Participants n=4 Participants	3 Participants n=10 Participants	5 Participants n=14 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=4 Participants	3 Participants n=10 Participants	4 Participants n=14 Participants
Race/Ethnicity, Customized Non-Hispanic Asian	1 Participants n=4 Participants	0 Participants n=10 Participants	1 Participants n=14 Participants
Region of Enrollment United States	4 participants n=4 Participants	10 participants n=10 Participants	14 participants n=14 Participants
Birthweight	1525 grams n=4 Participants	875 grams n=10 Participants	977 grams n=14 Participants
Small for gestational age	0 Participants n=4 Participants	2 Participants n=10 Participants	2 Participants n=14 Participants
Intrauterine growth restriction	0 Participants n=4 Participants	3 Participants n=10 Participants	3 Participants n=14 Participants
Preterm premature rupture of the membranes	1 Participants n=4 Participants • Baseline measure was unavailable for one participant	7 Participants n=9 Participants • Baseline measure was unavailable for one participant	8 Participants n=13 Participants • Baseline measure was unavailable for one participant

PRIMARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: Only the intervention arm is assessed for feasibility.

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.

Outcome measures

Measure	Attention Control Infants in the attention control group will receive standard of care.	M-MILK n=10 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Feasibility of Intervention	0 Participants	7 Participants

PRIMARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: 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.

The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale.

Outcome measures

Measure	Attention Control Infants in the attention control group will receive standard of care.	M-MILK n=5 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Acceptability of Intervention	0 Participants	5 Participants

PRIMARY outcome

Timeframe: 2 months corrected age

Retention will be described by the number of post-discharge follow-up surveys completed.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=10 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Retention	4 Participants	7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
The Scarf Sign Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	66.7 score on a scale Interval 66.7 to 66.7	66.7 score on a scale Interval 66.7 to 66.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Variability in the Motor Development & Vigor Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	53.1 score on a scale Interval 41.3 to 70.4	60.9 score on a scale Interval 49.2 to 75.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Popliteal Angle Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	16.7 score on a scale Interval 0.0 to 66.7	66.7 score on a scale Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	41.3 score on a scale Interval 7.5 to 69.1	82.5 score on a scale Interval 25.4 to 85.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Irritability Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	33.4 score on a scale Interval 16.7 to 33.4	33.4 score on a scale Interval 0.0 to 36.9

PRIMARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: Cry quality is only measured if the infant was crying during the assessment

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.

Outcome measures

Measure	Attention Control n=3 Participants Infants in the attention control group will receive standard of care.	M-MILK n=4 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Quality of Cry Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	0 score on a scale Interval 0.0 to 33.3	25 score on a scale Interval 0.0 to 75.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Percent Sleep Cluster of the Neurobehavioral Assessment of the Preterm Infants Score	14.3 score on a scale Interval 7.1 to 57.1	14.3 score on a scale Interval 0.0 to 57.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=7 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Early Feeding Skill Assessment Score	47.3 score on a scale Standard Deviation 3.9	49.6 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: Two parents in the M-MILK group did not complete this survey.

Scores range from 1 to 5, where higher scores indicate greater parental stress..

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=5 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Parent Stressor Scale: NICU Score	2.4 score on a scale Standard Deviation 1.2	2.3 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=6 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Parent Discharge Readiness Score	231.0 score on a scale Interval 199.5 to 246.5	211.0 score on a scale Interval 206.0 to 246.0

SECONDARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: Two parents in the M-MILK group did not report this data at discharge.

The percentage of mothers who report breastmilk pumping at discharge.

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=5 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Breastmilk Pumping Rate	1 Participants	5 Participants

SECONDARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

The percentage of mothers who report breastfeeding at discharge.

Outcome measures

Measure	Attention Control n=3 Participants Infants in the attention control group will receive standard of care.	M-MILK n=3 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Breastfeeding Rate	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Population: Two parents in the M-MILK group did not complete this survey.

Scores range from 0 to 30, where higher scores indicate greater depressive symptoms

Outcome measures

Measure	Attention Control n=4 Participants Infants in the attention control group will receive standard of care.	M-MILK n=5 Participants Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care.
Maternal Edinburgh Postnatal Depression Scale Score	3.8 score on a scale Standard Deviation 4.5	4.8 score on a scale Standard Deviation 4.9

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

Alpha diversity indices will be obtained. Differential abundance individual taxa will be obtained.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

The percent DNAm at the NR3C1 promoters and at each CpG site will be quantified.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.

The percent DNAm at the HSD11B2 promoters and at each CpG site will be quantified.

Outcome measures

Outcome data not reported

Adverse Events

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

M-MILK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thao Griffith

Loyola University Chicago

Phone: 464-220-9825

Email: tgriffith1@luc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place