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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024975-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt Kennedy Center | OTHER |
| National Center for Research Resources (NCRR) | NIH |
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Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing. These feeding difficulties often result in prolonged hospitalization, with increased physiologic stressors and poor growth. In preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor skills and decreased length of hospitalization.
The investigators propose to test the hypothesis that a week-long PAL intervention can improve feeding skills and decrease stress compared to standard of care parental interactions in infants in the late preterm period. The investigators also hypothesize that these improvements will result in shorter hospital stays and increased growth in the intervention group.
Our study design is a prospective randomized controlled trial design of 94 infants (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will receive a book library with one lullaby book and record her voice to the PAL, which the music therapist will then administer in 15-minute sessions for 5 consecutive days. The 47 participants in the control group will receive the same library but no recording will be made or PAL used. Outcomes measured will include time to full oral feeds, suck rate and efficiency, salivary cortisol levels before and after intervention, daily growth parameters and nutritional data, and hospital length of stay.
Objectives: We conducted a randomized trial to test the hypothesis that the mother's voice played through a pacifier-activated music (PAM) player during nonnutritive sucking would improve the development of sucking ability and promote more effective oral feeding in preterm infants.
Methods: Preterm infants between 34 0/7 and 35 6/7 weeks postmenstrual age, including those with brain injury, who were taking at least half their feedings enterally and less than half orally, were randomly assigned to receive 5 daily 15-minute sessions of either PAM with mother's recorded voice or no PAM, along with routine nonnutritive sucking and maternal care in both groups. Assignment was masked to the clinical team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacifier-Activated-Lullaby system (PAL) | Experimental | Pacifier-Activated-Lullaby system (PAL) group. |
|
| No PAL group | No Intervention | No PAL. Standard of care procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacifier-Activated-Lullaby system (PAL). | Device | Pacifier-Activated-Lullaby system (PAL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention | Day 0, and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge Weight | Description: Growth measures. | day of hospital discharge (approximately 5-7 weeks) |
| Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5) | Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olena D Chorna, MM, MT-BC | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
PI has left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full
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| ID | Title | Description |
|---|---|---|
| FG000 | Books, PAL Group | PAL group Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL). |
| FG001 | Books, No PAL Group | No PAL At enrollment, all mother-infant dyads received a set of 4 well-known children's books, 2 of which were single-story songbooks. Mothers in both groups were encouraged to read and sing to their infants whenever they were present; no time quota, schedule, or log was provided. Mothers were informed that the study's objective was to evaluate the influence of their voice on their infant's feeding ability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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NICU infants
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| ID | Title | Description |
|---|---|---|
| BG000 | Books, PAL Group | PAL group Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL). Infants were randomly assigned by using a block system to control or intervention groups. Eligible siblings were enrolled into the same group because they shared the same room in the NICU. If 1 child received the PAM intervention while the other engaged in NNS, diffusion of treatment might occur; removal of the siblings' pacifier during the pacifier-activated lullaby (PAL) was not an alternative acceptable to nursing staff. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention | Posted | Mean | Inter-Quartile Range | mL/min | Day 0, and Day 5 |
|
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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 | PAL Group | PAL group Pacifier-Activated-Lullaby system (PAL).: Pacifier-Activated-Lullaby system (PAL). |
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PI left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olena Chorna | Vanderbilt University | 850-508-5571 | olena.chorna@vanderbilt.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Day 0, and Day 5 |
| Hospital Length of Stay | Description: Data on hospital stay was recorded from the chart. The participants were be followed for the duration of the hospital stay from the time of consent for participation to the time discharge from the NICU is documented. | days from consent to discharge |
| Number of Days to Full Oral Feeds | Aim: Quantify the effect of the PAL intervention on efficiency of sucking and time to reaching full oral feeds in comparison to controls. Data on the number of days from Day 0 of the study to the date of first documented full oral feed, up to 70 days (or date of death from any cause) were be recorded from the chart. | Day 0 of the study to the date of first documented full oral feed (up to 70 days) |
| BG001 | Books, No PAL Group | No PAL |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Birth weight, g, median | Median | Inter-Quartile Range | grams |
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| White matter injury | White matter injury information was derived from the medical record, as approved by the Ethics board. | Number | number of participants |
|
| Feeding rate at study start | Mean | Inter-Quartile Range | ml/min |
|
| No. of oral feedings/d at study start | Median | Full Range | feedings per day |
|
| Units | Counts |
|---|
| Participants |
|
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| Secondary | Discharge Weight | Description: Growth measures. | Posted | Median | Inter-Quartile Range | grams | day of hospital discharge (approximately 5-7 weeks) |
|
|
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| Secondary | Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5) | Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group. | Specific data is no longer available, Outcome is described here: http://pediatrics.aappublications.org/content/133/3/462.full | Posted | Day 0, and Day 5 |
|
|
| Secondary | Hospital Length of Stay | Description: Data on hospital stay was recorded from the chart. The participants were be followed for the duration of the hospital stay from the time of consent for participation to the time discharge from the NICU is documented. | Posted | Median | Inter-Quartile Range | days | days from consent to discharge |
|
|
|
| Secondary | Number of Days to Full Oral Feeds | Aim: Quantify the effect of the PAL intervention on efficiency of sucking and time to reaching full oral feeds in comparison to controls. Data on the number of days from Day 0 of the study to the date of first documented full oral feed, up to 70 days (or date of death from any cause) were be recorded from the chart. | Posted | Median | Inter-Quartile Range | days | Day 0 of the study to the date of first documented full oral feed (up to 70 days) |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Books, No PAL Group | No PAL | 0 | 48 | 0 | 48 |
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| D000091642 | Urogenital Diseases |