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Completed

NCT Number: NCT06230848

Multisensory Early Oral Administration of Human Milk in Preterm Infants

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.

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Key information

Conditions

Infant Development Stress

Age range

0 year–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Retention

    Time frame: 2 months corrected age

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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Parent Stressor Scale: NICU Score

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

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

  2. Parent Discharge Readiness Score

    Time frame: 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.

  3. Breastmilk Pumping Rate

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

    The percentage of mothers who report breastmilk pumping at discharge.

  4. Breastfeeding Rate

    Time frame: 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.

  5. Maternal Edinburgh Postnatal Depression Scale Score

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

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

Other outcomes

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

    Time frame: 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.

  2. Variability in DNA Methylation of NR3C1 Promoter

    Time frame: 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.

  3. Variability in DNA Methylation of HSD11B2 Promoter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study 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

Acronym: M-MILK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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