Clinical trial NCT04337476: The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants
Official title: The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants: an Italian Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Keywords: Music therapy
Preterm
PAL
HRV
Parental voice
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial, divided into four parallel groups of preterm infants
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: through study completion (from 5 minutes before the test to 5 minutes after the test ended)
Secondary outcomes:
measure: Full oral feeding
timeFrame: more or less than 35 post conceptional weeks
measure: oral feeding velocity
timeFrame: more or less than 30 minutes
measure: weight gain
timeFrame: 24 hours after test
measure: lenght of stay
timeFrame: more or less than 36 post conceptional weeks
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale F. Del Ponte
Study officials:
affiliation: Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
name: Massimo Agosti, MD
role: PRINCIPAL_INVESTIGATOR
References: