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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Stressor Scale: NICU Score | Scores range from 1 to 5, where higher scores indicate greater parental stress.. | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
| Parent Discharge Readiness Score |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in Gut Microbial Community Structure and Relative Abundance of SCFA- and Lactate- Producing Bacteria | Alpha diversity indices will be obtained. Differential abundance individual taxa will be obtained. | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
| Variability in DNA Methylation of NR3C1 Promoter |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | Infants in the attention control group will receive standard of care. |
| FG001 | M-MILK | Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled and completed baseline assessments
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | Infants in the attention control group will receive standard of care. |
| BG001 | M-MILK | Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age at birth measured in weeks |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only the intervention arm is assessed for feasibility. | Posted | Count of Participants | Participants | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
Adverse events were evaluated from randomization to hospital discharge, which is typically 10 to 16 weeks from birth.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control | Infants in the attention control group will receive standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thao Griffith | Loyola University Chicago | 464-220-9825 | tgriffith1@luc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2024 | Nov 21, 2025 | Prot_SAP_000.pdf |
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|
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. |
Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge.
| 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. | 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. | 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 | 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. |
| At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
| Variability in DNA Methylation of HSD11B2 Promoter | The percent DNAm at the HSD11B2 promoters and at each CpG site will be quantified. | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Birthweight | Birthweight in grams | Median | Full Range | grams |
|
| Small for gestational age | Count of Participants | Participants |
|
| Intrauterine growth restriction | Count of Participants | Participants |
|
| Preterm premature rupture of the membranes | Baseline measure was unavailable for one participant | Count of Participants | Participants |
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| Primary | Acceptability of Intervention | The percentage of parents who rate the intervention as very positive, slightly positive, or acceptable on a 5-point Likert scale. | 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. | Posted | Count of Participants | Participants | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Primary | Retention | Retention will be described by the number of post-discharge follow-up surveys completed. | Posted | Count of Participants | Participants | 2 months corrected age |
|
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| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Cry quality is only measured if the infant was crying during the assessment | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
|
|
|
| Secondary | Parent Stressor Scale: NICU Score | Scores range from 1 to 5, where higher scores indicate greater parental stress.. | Two parents in the M-MILK group did not complete this survey. | Posted | Mean | Standard Deviation | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Secondary | Parent Discharge Readiness Score | Scores range from 44 to 308, where higher scores indicate more parental readiness for discharge. | Posted | Median | Inter-Quartile Range | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Secondary | Breastmilk Pumping Rate | The percentage of mothers who report breastmilk pumping at discharge. | Two parents in the M-MILK group did not report this data at discharge. | Posted | Count of Participants | Participants | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Secondary | Breastfeeding Rate | The percentage of mothers who report breastfeeding at discharge. | Posted | Count of Participants | Participants | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Secondary | Maternal Edinburgh Postnatal Depression Scale Score | Scores range from 0 to 30, where higher scores indicate greater depressive symptoms | Two parents in the M-MILK group did not complete this survey. | Posted | Mean | Standard Deviation | score on a scale | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. |
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| Other Pre-specified | Variability in Gut Microbial Community Structure and Relative Abundance of SCFA- and Lactate- Producing Bacteria | Alpha diversity indices will be obtained. Differential abundance individual taxa will be obtained. | Not Posted | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. | Participants |
| Other Pre-specified | Variability in DNA Methylation of NR3C1 Promoter | The percent DNAm at the NR3C1 promoters and at each CpG site will be quantified. | Not Posted | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. | Participants |
| Other Pre-specified | Variability in DNA Methylation of HSD11B2 Promoter | The percent DNAm at the HSD11B2 promoters and at each CpG site will be quantified. | Not Posted | At the time of discharge from NICU, which is typically 10 to 16 weeks from birth. | Participants |
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | M-MILK | Infants in the M-MILK group will receive the M-MILK intervention in addition to standard of care. | 0 | 10 | 0 | 10 | 0 | 10 |
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