Prematurity
Conditions
Keywords
Neonatal Intensive Care Unit (NICU), Music therapy, Premature infant, Oral feeds, Non-Nutritive Sucking, Suck rate, Suck efficiency, Contingent music, Mother's voice
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPacifier-Activated-Lullaby system (PAL).
Pacifier-Activated-Lullaby system (PAL).
Sponsors
Vanderbilt Kennedy Center
National Center for Research Resources (NCRR)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
34 Weeks to 36 Weeks
Healthy volunteers
No
Inclusion criteria
* All infants at 34 0/7 to 35 6/7 weeks post-conceptional age cared for in the Vanderbilt NICU who are receiving more than 50 % of their nutrition as enteral feeds, and are in individual rooms or in the room with their sibling.
Exclusion criteria
* infants on ventilators or Continuous Positive Airway Pressure (CPAP), * infants determined to be unsafe to feed orally by the medical team or the feeding/speech specialists at Vanderbilt.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | Day 0, and 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Weight | day of hospital discharge (approximately 5-7 weeks) | Description: Growth measures. |
| Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5) | Day 0, and Day 5 | Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group. |
| Hospital Length of Stay | days from consent to discharge | 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. |
| Number of Days to Full Oral Feeds | Day 0 of the study to the date of first documented full oral feed (up to 70 days) | 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. |
Countries
United States
Participant flow
Pre-assignment details
PI has left Vanderbilt, data obtained from publication http://pediatrics.aappublications.org/content/133/3/462.full
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Books, No PAL Group No PAL | 48 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Books, PAL Group | Books, No PAL Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 48 Participants | 94 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Birth weight, g, median | 1495 grams | 1405 grams | 1450 grams |
| Feeding rate at study start | 0.6 ml/min | 0.6 ml/min | 0.6 ml/min |
| No. of oral feedings/d at study start | 2 feedings per day | 2 feedings per day | 2 feedings per day |
| Region of Enrollment United States | 46 participants | 48 participants | 94 participants |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 24 Participants | 23 Participants | 47 Participants |
| White matter injury | 7 number of participants | 9 number of participants | 16 number of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 |
Outcome results
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
Time frame: Day 0, and Day 5
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PAL Intervention | Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | 2.0 mL/min |
| No PAL Intervention | Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) | 0.9 mL/min |
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.
Time frame: Day 0, and Day 5
Population: Specific data is no longer available, Outcome is described here: http://pediatrics.aappublications.org/content/133/3/462.full
Secondary
Discharge Weight
Description: Growth measures.
Time frame: day of hospital discharge (approximately 5-7 weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PAL Intervention | Discharge Weight | 2000 grams |
| No PAL Intervention | Discharge Weight | 1990 grams |
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.
Time frame: days from consent to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PAL Intervention | Hospital Length of Stay | 41 days |
| No PAL Intervention | Hospital Length of Stay | 50 days |
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.
Time frame: Day 0 of the study to the date of first documented full oral feed (up to 70 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PAL Intervention | Number of Days to Full Oral Feeds | 31 days |
| No PAL Intervention | Number of Days to Full Oral Feeds | 38 days |