The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby

NCT04759170 | Completed DMC

• 1 other identifier: 186
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. 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 also to observe the possible effects on his well-being and on his clinical stability.

Conditions

Music Therapy

Keywords

Music therapy; Hrv; Premature; Preterm; Music recorded receptive; Parents voice; feeding time; music therapist voice

Outcome Measures

Primary Outcomes (1)

• Clinical stability by measuring Heart Rate Variability (HRV)

  Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV

  8 day

Secondary Outcomes (4)

• Effects of positive reinforcement carried out through the use of recorded receptive music therapy

  through study completion, an average of 20 weeks

• Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills

  through study completion, an average of 20 weeks

• Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants.

  through study completion, an average of 20 weeks

• Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants.

  through study completion, an average of 20 weeks

Other Outcomes (1)

• Length of hospital stay after music therapy treatment

  through study completion, an average of 20 weeks

Study Arms (4)

Mother Recorded Receptive Music Therapy Intervention

OTHER

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Other: Music therapy

Fother Recorded Receptive Music Therapy Intervention

OTHER

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Other: Music therapy

Music therapist Recorded Receptive Music therapy intervention

OTHER

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Other: Music therapy

No singing

OTHER

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Other: Music therapy

Interventions

Music therapy OTHER

The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Fother Recorded Receptive Music Therapy Intervention; Mother Recorded Receptive Music Therapy Intervention; Music therapist Recorded Receptive Music therapy intervention; No singing

Eligibility Criteria

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

You may qualify if:

• Infants with gestational age at birth between the 23rd and 34th week of gestation
• Neonates with intraventricular hemorrhage (IVH)
• Neonates with periventricular leukomalacia (PVL)

You may not qualify if:

• Only newborns in ventilatory support at the time of evaluation
• Newborns with maxillofacial malformations
• Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake
• Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term

Sponsors & Collaborators

• Ospedale di Circolo - Fondazione Macchi: lead

Study Sites (1)

Ospedale F. Del Ponte

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 18, 2021
• Study Start: August 30, 2020
• Primary Completion: February 10, 2021
• Study Completion: December 27, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)