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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04759170
Recruitment Status : Completed
First Posted : February 18, 2021
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi

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.

Condition or disease Intervention/treatment Phase
Music Therapy Other: Music therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby: Prospective Randomized Controlled Study Mom, Dad and Music Therapist Singing Voice
Actual Study Start Date : August 30, 2020
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : December 27, 2021

Arm Intervention/treatment
Mother Recorded Receptive Music Therapy Intervention
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Other: Music therapy
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Fother Recorded Receptive Music Therapy Intervention
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Other: Music therapy
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Music therapist Recorded Receptive Music therapy intervention
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Other: Music therapy
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby

No singing
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Other: Music therapy
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby




Primary Outcome Measures :
  1. Clinical stability by measuring Heart Rate Variability (HRV) [ Time Frame: 8 day ]
    Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV


Secondary Outcome Measures :
  1. Effects of positive reinforcement carried out through the use of recorded receptive music therapy [ Time Frame: through study completion, an average of 20 weeks ]
    Evaluation of the achievement of exclusive oral sucking

  2. Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills [ Time Frame: through study completion, an average of 20 weeks ]
    Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention.

  3. Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants. [ Time Frame: through study completion, an average of 20 weeks ]
    Evaluation of the weight gain of the newborn in the 24 hours following stimulation.

  4. Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants. [ Time Frame: through study completion, an average of 20 weeks ]
    Assessment of the growth rate from the last day of treatment to discharge.


Other Outcome Measures:
  1. Length of hospital stay after music therapy treatment [ Time Frame: through study completion, an average of 20 weeks ]
    Length of hospital stay.



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Ages Eligible for Study:   23 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759170


Locations
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Italy
Ospedale F. Del Ponte
Varese, Italy, 21100
Sponsors and Collaborators
Ospedale di Circolo - Fondazione Macchi
Investigators
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Principal Investigator: Massimo Agosti, MD Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
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Responsible Party: Barbara Sgobbi, Music Therapist, Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier: NCT04759170    
Other Study ID Numbers: 186
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi:
Music therapy
Hrv
Premature
Preterm
Music recorded receptive
Parents voice
feeding time
music therapist voice
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications