An interventional study of The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention in Music Therapy, sponsored by Ospedale di Circolo - Fondazione Macchi. Completed at 1 site in Italy. Open to participants aged 23 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Ospedale di Circolo - Fondazione Macchi · Not applicable, Interventional, and Treatment
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.
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:
Exclusion Criteria:
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
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
Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
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
Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
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
Device: The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy 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.
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.
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
Time frame: through study completion (from 5 minutes before the test to 5 minutes after the test ended)
Full oral feeding
Full oral feeding (\> 150 ml/kg/day) achievement, expressed as post-conceptional weeks.
Time frame: more or less than 35 post conceptional weeks
oral feeding velocity
time (expressed as minutes) necessary to consume oral feeding
Time frame: more or less than 30 minutes
weight gain
% weight increase 24 hours after test administration
Time frame: 24 hours after test
lenght of stay
length of hospitalization (expressed as post-conceptional weeks at discharge)
Time frame: more or less than 36 post conceptional weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ospedale di Circolo - Fondazione Macchi