Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759170
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2021-01-28
Brief Title:
The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby
Sponsor:
Ospedale di Circolo - Fondazione Macchi
Organization:
Ospedale di Circolo - Fondazione Macchi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mothers 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 infants 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
Detailed Description:
In preterm infant oral feeding requires significant maturation of the nervous system to support coordination of the oropharyngeal muscles and breathing Additionally the energy expenditure required by nutritional sucking attempts further complicates the acquisition of oral feeding skills and must be balanced by caloric intake to achieve sufficient growth Achievement of exclusive autonomous sucking typically occurs only between 34 and 36 post-conception weeks However delays in achieving full oral sucking are common and may prolong the infants hospitalizationNon-nutritive sucking NNS is a coordinated motor skill that can be taught through an educational activity that conditions neuronal responses through positive reinforcementThe international literature demonstrates that through a behavioral approach the use of the pacifier during non-nutritive sucking promotes nutritional sucking in preterm infants improving their attachment and bottle feeding and determines the reduction of the length of stay in intensive care and improved general well-being of the newbornThe use of receptive music therapy can therefore be supportive and represent a positive reinforcement for the development and acquisition of oral and nutritional skills of the preterm infant By taking advantage of non-nutritive sucking it is possible to improve the suckling capacity of the newborn his feeding speed weight gain and consequently reduce the length of hospital stay It is essential to achieve this result without negatively affecting the well-being and stability of the preterm infant
Although musical studies in premature infants are limited a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infantOn the other hand the possible similar effects of reproduction through the use of receptive music therapy of the song of the father and or the music therapist have not yet been investigated The investigators therefore decided to design a prospective randomized and controlled study to test the hypothesis that the parental maternal and or paternal and or music therapists chant influences the well-being and or stress of the newborn evaluated through the parameter Heart Rate Variability HRV NNS development nutritional sucking capacity weight growth and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation 40 premature babies will be recruited to be divided into 4 groups after computerized randomization n 3 musical groups mother song father song music therapist song and 1 control group not subjected to musical stimulation Infants with gestational age at birth between the 23rd and 34th week of gestation will be included Neonates with intraventricular hemorrhage IVH and periventricular leukomalacia PVL may also be enrolled Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment 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 intakeInfants who have not passed the subsequent hearing screening test using AABR Brain Stem Automatic Response Test will be excluded from the analysis which is expected to be performed after reaching the correct age limit
OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant Evaluating how this can affect the clinical stability of the newborn and therefore on his state of stress measured in terms of HRV represents a fundamental and primary point to explore in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention in terms of clinical stability assessed through the HRV parameter by the enrolled infants and to investigate any benefits of positive reinforcement obtained through its use on the acquisition of nutrition and growth skills of preterm infants
Primary outcomes clinical stability by measuring Heart Rate Variability HRV
The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy in terms of measurement of the clinical stability parameter HRV by infants during music therapy treatment
Secondary outcomes effects of positive reinforcement carried out through the use of receptive music therapy on the acquisition of food skills and the growth of preterm infants In particular
Evaluation of the achievement of exclusive oral sucking determined as a week post-conception and or days of life
Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption
Evaluation of the weight gain of the newborn in the 24 hours following stimulation
expressed as a percentage of weight gain from enrollment
Assessment of the growth rate from the last day of treatment to discharge
Length of hospital stay
Although musical studies in premature infants are limited a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infantOn the other hand the possible similar effects of reproduction through the use of receptive music therapy of the song of the father and or the music therapist have not yet been investigated The investigators therefore decided to design a prospective randomized and controlled study to test the hypothesis that the parental maternal and or paternal and or music therapists chant influences the well-being and or stress of the newborn evaluated through the parameter Heart Rate Variability HRV NNS development nutritional sucking capacity weight growth and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation 40 premature babies will be recruited to be divided into 4 groups after computerized randomization n 3 musical groups mother song father song music therapist song and 1 control group not subjected to musical stimulation Infants with gestational age at birth between the 23rd and 34th week of gestation will be included Neonates with intraventricular hemorrhage IVH and periventricular leukomalacia PVL may also be enrolled Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment 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 intakeInfants who have not passed the subsequent hearing screening test using AABR Brain Stem Automatic Response Test will be excluded from the analysis which is expected to be performed after reaching the correct age limit
OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant Evaluating how this can affect the clinical stability of the newborn and therefore on his state of stress measured in terms of HRV represents a fundamental and primary point to explore in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention in terms of clinical stability assessed through the HRV parameter by the enrolled infants and to investigate any benefits of positive reinforcement obtained through its use on the acquisition of nutrition and growth skills of preterm infants
Primary outcomes clinical stability by measuring Heart Rate Variability HRV
The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy in terms of measurement of the clinical stability parameter HRV by infants during music therapy treatment
Secondary outcomes effects of positive reinforcement carried out through the use of receptive music therapy on the acquisition of food skills and the growth of preterm infants In particular
Evaluation of the achievement of exclusive oral sucking determined as a week post-conception and or days of life
Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption
Evaluation of the weight gain of the newborn in the 24 hours following stimulation
expressed as a percentage of weight gain from enrollment
Assessment of the growth rate from the last day of treatment to discharge
Length of hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None