The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants

NCT04337476 | Completed

• 1 other identifier: PAL- 176
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Music Therapy

Keywords

Music therapy; Preterm; PAL; HRV; Parental voice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Full oral feeding

  more or less than 35 post conceptional weeks

• oral feeding velocity

  more or less than 30 minutes

• weight gain

  24 hours after test

• lenght of stay

  more or less than 36 post conceptional weeks

Study Arms (4)

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

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

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

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.

Interventions

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

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.

father's song; mother's song; singing of the music therapist

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale di Circolo - Fondazione Macchi: lead

Study Sites (1)

Ospedale F. Del Ponte

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Massimo Agosti, MD

  Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: After acquiring informed consent, participants will be randomized randomly through computerized, block randomization by intervention group or group of control, which will assign a specific group to the newborns (mom voice, dad voice, music therapist voice or no voice). The clinical team and parents will be blind to the study group and will not know when the recordings will be reproduced. The administration of the PAL and the reproduction of the relative voices will be performed by the music therapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist

Model Details: Prospective randomized controlled trial, divided into four parallel groups of preterm infants

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 7, 2020
• Study Start: April 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)