PrematurityNCT01600586
A Clinical Trial of A Pacifier-Activated Music Player
A study testing Pacifier-Activated-Lullaby system (PAL). in people with Prematurity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 36 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Pacifier-Activated-Lullaby system (PAL).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants
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.
Read the 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.
- Conditions
- Prematurity
- Being tested
- Pacifier-Activated-Lullaby system (PAL).
- Keywords
- Neonatal Intensive Care Unit (NICU), Music therapy, Premature infant, Oral feeds, Non-Nutritive Sucking, Suck rate, Suck efficiency, Contingent music, Mother's voice
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifier-Activated-Lullaby system (PAL).Device
Pacifier-Activated-Lullaby system (PAL).
| Study group | Role | What they receive |
|---|---|---|
| Pacifier-Activated-Lullaby system (PAL) | Experimental | Pacifier-Activated-Lullaby system (PAL) group. Receives: Device: Pacifier-Activated-Lullaby system (PAL). |
| No PAL group | No intervention | No PAL. Standard of care procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0, and Day 5
Secondary outcomes (4)
Discharge Weight
Description: Growth measures.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 of the study to the date of first documented full oral feed (up to 70 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt Kennedy Center, National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Olena D Chorna, MM, MT-BC, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600586
- Sponsor's protocol ID
- VKC 4-30-100-9622
- Other IDs
- UL1RR024975-01
- Status last verified
- Apr 2018
- First submitted
- 9 May 2012
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT01600586
- Acronym / sponsor ID
- VKC 4-30-100-9622
- Conditions
- Prematurity
- Keywords
- Neonatal Intensive Care Unit (NICU), Music therapy, Premature infant, Oral feeds, Non-Nutritive Sucking, Suck rate, Suck efficiency, Contingent music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Vanderbilt Kennedy Center, National Center for Research Resources (NCRR)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 7 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacifier-Activated-Lullaby system (PAL) | Experimental | Device: Pacifier-Activated-Lullaby system (PAL).Pacifier-Activated-Lullaby system (PAL) group. |
| No PAL group | No intervention | –No PAL. Standard of care procedures. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacifier-Activated-Lullaby system (PAL).Pacifier-Activated-Lullaby system (PAL). | Device | Pacifier-Activated-Lullaby system (PAL) |
Primary outcome
Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)
Time frame: 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
4 secondary outcomes
Discharge Weight
Time frame: day of hospital discharge (approximately 5-7 weeks)
Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5)
Time frame: Day 0, and Day 5
Hospital Length of Stay
Time frame: days from consent to discharge
Number of Days to Full Oral Feeds
Time frame: Day 0 of the study to the date of first documented full oral feed (up to 70 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olena D Chorna, MM, MT-BC principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacifier-Activated-Lullaby system (PAL). in people with Prematurity, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) (time frame: Day 0, and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.