Music TherapyPALNCT04337476
The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants
A study testing The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention in people with Music Therapy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing care, to improve premature neonates' neurophysiological development. Read more about this study
- Who is it for?
- Ages 23 to 34 weeks
- Conditions the study is for
- Music Therapy
- What is being tested?
- The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 23 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age between the 23th and the 34th week, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Who cannot join
- Chromosomal aberrations, congenital maxillofacial malformations, respiratory support at evaluation time Neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing will be subsequently excluded
- Infants will be evaluated at 32-34 post-conceptional weeks when the volume of milk assumed orally will be less than 50% of the total enteral intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants: an Italian Randomized Pilot Study
Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing care, to improve premature neonates' neurophysiological development.
Recent studies focused on the effects of the maternal voice or the entrained singing and live music, highlighting their benefits on neonates stress, on not-nutritive sucking and on the caloric intake.
Read more
Aim of our study is to evaluate the effect of parents singing or musictherapist singing admistered by Pacifier Activated Lullaby (PAL) on infant's behavior and nutritional outcomes.
Particularly, we will evaluate infants' Heart Rate Variability during music therapy session, exclusive oral feeding achievement, weigth increase and hospitalization in a group of preterm infants administered to PAL compared with a control group of preterm infants not exposed to PAL stimulus.
Read the detailed description
A Prospective randomized controlled pilot study trial will be conducted. Infants will be evaluated at 32-34 post-conceptional weeks when the volume of milk assumed orally will be less than 50% of the total enteral intake.
Infants with gestational age less than 34 weeks will be enrolled. After the request for informed consent, participants will be randomized randomly through computerized.
The administration of the PAL and the reproduction of the relative voices will be performed by the music therapist.
Objective of this study is to evaluate the tolerance (in terms of clinical stability, described through the HRV parameter) of the PAL device by the enrolled customers and investigate any benefits of the positive reinforcement purchased, through its use, on the acquisition of food skills and on the growth of preterms.
Primary Outcome: Clinical Stability Using Heart Rate Variability (HRV) Measurement during the music therapy treatment.
Secondary Outcomes: effects of positive reinforcement (obtained through the use of the device PAL) on the acquisition of food skills and the growth of preterm consumers.
In particular:
- Evaluation of the achievement of the exclusive oral sucking
- Evaluation of the variation in the rate of meal intake between the beginning and the end of the intervention
- Assessment of the infant's weight gain in the 24 hours following stimulation
- Evaluation of the rate of growth from the last day of treatment to discharge.
- Duration of hospital stay.
- Conditions
- Music Therapy
- Being tested
- The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
- Keywords
- Music therapy, Preterm, PAL, HRV, Parental 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.
The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy interventionDevice
Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief intervention with the PAL device with pacifier that reproduces lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospital stay in preterm infants. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time to observe its possible effects on its well-being and its clinical stability.
| Study group | Role | What they receive |
|---|---|---|
| mother's song | Experimental | At the suggestion of the music therapist, the mothers of each child will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit Receives: Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention |
| father's song | Experimental | At the suggestion of the music therapist, the fathers of each child will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit Receives: Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention |
| singing of the music therapist | Experimental | Music therapist will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit Receives: Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention |
| No singing | No intervention | Control group (not subjected to musical stimulation- no singing). During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart Rate Variability (HRV) according to different music genres listening. An electrocardiogram is performed to evaluate HRV parameters during the test's administration
Measured: through study completion (from 5 minutes before the test to 5 minutes after the test ended)
Secondary outcomes (4)
Full oral feeding
Full oral feeding (> 150 ml/kg/day) achievement, expressed as post-conceptional weeks.
Measured: more or less than 35 post conceptional weeks
oral feeding velocity
time (expressed as minutes) necessary to consume oral feeding
Measured: more or less than 30 minutes
weight gain
% weight increase 24 hours after test administration
Measured: 24 hours after test
lenght of stay
length of hospitalization (expressed as post-conceptional weeks at discharge)
Measured: more or less than 36 post conceptional weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start30 Apr 2020
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- 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
- Model description
- Prospective randomized controlled trial, divided into four parallel groups of preterm infants
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Massimo Agosti, MD, Principal investigator, Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337476
- Sponsor's protocol ID
- PAL- 176
- Acronym
- PAL
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants: an Italian Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04337476
- Acronym / sponsor ID
- PAL / PAL- 176
- Conditions
- Music Therapy
- Keywords
- Music therapy, Preterm, PAL, HRV, Parental voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing care, to improve premature neonates' neurophysiological development.
Recent studies focused on the effects of the maternal voice or the entrained singing and live music, highlighting their benefits on neonates stress, on not-nutritive sucking and on the caloric intake.
Aim of our study is to evaluate the effect of parents singing or musictherapist singing admistered by Pacifier Activated Lullaby (PAL) on infant's behavior and nutritional outcomes.
Particularly, we will evaluate infants' Heart Rate Variability during music therapy session, exclusive oral feeding achievement, weigth increase and hospitalization in a group of preterm infants administered to PAL compared with a control group of preterm infants not exposed to PAL stimulus.
Detailed description
A Prospective randomized controlled pilot study trial will be conducted. Infants will be evaluated at 32-34 post-conceptional weeks when the volume of milk assumed orally will be less than 50% of the total enteral intake.
Infants with gestational age less than 34 weeks will be enrolled. After the request for informed consent, participants will be randomized randomly through computerized.
The administration of the PAL and the reproduction of the relative voices will be performed by the music therapist.
Objective of this study is to evaluate the tolerance (in terms of clinical stability, described through the HRV parameter) of the PAL device by the enrolled customers and investigate any benefits of the positive reinforcement purchased, through its use, on the acquisition of food skills and on the growth of preterms.
Primary Outcome: Clinical Stability Using Heart Rate Variability (HRV) Measurement during the music therapy treatment.
Secondary Outcomes: effects of positive reinforcement (obtained through the use of the device PAL) on the acquisition of food skills and the growth of preterm consumers.
In particular:
- Evaluation of the achievement of the exclusive oral sucking
- Evaluation of the variation in the rate of meal intake between the beginning and the end of the intervention
- Assessment of the infant's weight gain in the 24 hours following stimulation
- Evaluation of the rate of growth from the last day of treatment to discharge.
- Duration of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- Prospective randomized controlled trial, divided into four parallel groups of preterm infants
| Arm | Type | Receives |
|---|---|---|
| mother's song | Experimental | Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy interventionAt the suggestion of the music therapist, the mothers of each child will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit |
| father's song | Experimental | Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy interventionAt the suggestion of the music therapist, the fathers of each child will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit |
| singing of the music therapist | Experimental | Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy interventionMusic therapist will record two lullabies sung by themselves; lullabies will be part of traditional classical literature. The songs will be recorded and loaded on a simplified digital software to modify any background noise or pauses. The recording will be inserted in the usb / sd flash drive used directly by the PAL device. During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit |
| No singing | No intervention | –Control group (not subjected to musical stimulation- no singing). During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit. |
Who may qualify
- Ages
- 23 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- gestational age between the 23th and the 34th week, sufficient stability of the vital parameters and absence of active infections and episodes of apnoea during the 72 hours before the test
Key exclusion criteria (2 listed)
- Chromosomal aberrations, congenital maxillofacial malformations, respiratory support at evaluation time Neonates with failed responses to bilateral hearing screening performed by Automated Auditory Brainstem Response testing will be subsequently excluded
- Infants will be evaluated at 32-34 post-conceptional weeks when the volume of milk assumed orally will be less than 50% of the total enteral intake
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 |
|---|---|---|
| The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy interventionPositive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief intervention with the PAL device with pacifier that reproduces lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospital stay in preterm infants. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time to observe its possible effects on its well-being and its clinical stability. | Device | father's song, mother's song, singing of the music therapist |
Primary outcome
Heart Rate Variability
Time frame: through study completion (from 5 minutes before the test to 5 minutes after the test ended)
Heart Rate Variability (HRV) according to different music genres listening. An electrocardiogram is performed to evaluate HRV parameters during the test's administration
4 secondary outcomes
Full oral feeding
Time frame: more or less than 35 post conceptional weeks
oral feeding velocity
Time frame: more or less than 30 minutes
weight gain
Time frame: 24 hours after test
lenght of stay
Time frame: more or less than 36 post conceptional weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Music Therapy
RecruitingPhase 2
Gaze-Contingent Music Therapy Augmentation of CBT for Pediatric Anxiety
Psychiatric Disorders, Anxiety Disorders
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Recruiting
Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
Substance Use Disorder (SUD)
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.
Massimo Agosti, MD principal investigator
Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention in people with Music Therapy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
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 20 Apr 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart Rate Variability (time frame: through study completion (from 5 minutes before the test to 5 minutes after the test ended)). 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 20 Apr 2022.