The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants

Music Therapy Clinical Trial

— PAL  

Official title:

The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants: an Italian Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337476
• Other study ID #: PAL- 176
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2022
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Music Therapy
• Premature Birth

Intervention

Device:
• The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
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.

Locations

Country	Name	City	State
Italy	Ospedale F. Del Ponte	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion (from 5 minutes before the test to 5 minutes after the test ended)
Secondary	Full oral feeding	Full oral feeding (> 150 ml/kg/day) achievement, expressed as post-conceptional weeks.	more or less than 35 post conceptional weeks
Secondary	oral feeding velocity	time (expressed as minutes) necessary to consume oral feeding	more or less than 30 minutes
Secondary	weight gain	% weight increase 24 hours after test administration	24 hours after test
Secondary	lenght of stay	length of hospitalization (expressed as post-conceptional weeks at discharge)	more or less than 36 post conceptional weeks