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Completed

NCT Number: NCT04337476

The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants

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.

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Key information

Conditions

Music Therapy Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale F. Del Ponte

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Full oral feeding

    Time frame: more or less than 35 post conceptional weeks

    Full oral feeding (> 150 ml/kg/day) achievement, expressed as post-conceptional weeks.

  2. oral feeding velocity

    Time frame: more or less than 30 minutes

    time (expressed as minutes) necessary to consume oral feeding

  3. weight gain

    Time frame: 24 hours after test

    % weight increase 24 hours after test administration

  4. lenght of stay

    Time frame: more or less than 36 post conceptional weeks

    length of hospitalization (expressed as post-conceptional weeks at discharge)

Sponsors and collaborators

Lead sponsor

Ospedale di Circolo - Fondazione Macchi

Other

Registry information

Official study title

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

Acronym: PAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2020
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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