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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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.
Loyola University Chicago
Maywood, Illinois, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.
Parent Stressor Scale: NICU Score
Scores range from 1 to 5, where higher scores indicate greater parental stress..
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.