Multisensory Early Oral Administration of Human Milk in Preterm Infants

NCT06230848 | Completed Results

• 1 other identifier: 217411
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stress; Infant Development

Keywords

stress; preterm infants; epigenetics; gut microbiome; parent-infant relationship

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (5)

• Parent Stressor Scale: NICU Score

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

• Parent Discharge Readiness Score

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

• Breastmilk Pumping Rate

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

• Breastfeeding Rate

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

• Maternal Edinburgh Postnatal Depression Scale Score

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

Other Outcomes (3)

• Variability in Gut Microbial Community Structure and Relative Abundance of SCFA- and Lactate- Producing Bacteria

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

• Variability in DNA Methylation of NR3C1 Promoter

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

• Variability in DNA Methylation of HSD11B2 Promoter

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

Study Arms (2)

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.

Other: Multisensory Early Oral Administration of Human Milk (M-MILK)

Interventions

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.

M-MILK

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Results Point of Contact

• Title: Dr. Thao Griffith
• Organization: Loyola University Chicago

tgriffith1@luc.edu

464-220-9825

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 30, 2024
• Study Start: October 23, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)