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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Alertness and Orientation Cluster of the Neurobehavioral Assessment of the Preterm Infants Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Retention
Time Frame: 2 months corrected age
Retention will be described by the number of post-discharge follow-up surveys completed.
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.
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.
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.
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.
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.
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.
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.
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
- 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.)
- Maternal Edinburgh Postnatal Depression Scale Score(At the time of discharge from NICU, which is typically 10 to 16 weeks from birth.)
- 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.)
Investigators
Thao Griffith
Assistant Professor
Loyola University