Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04759170 |
| Other study ID # |
186 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2020 |
| Est. completion date |
December 27, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Ospedale di Circolo - Fondazione Macchi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 infant's hospitalization.Non-nutritive sucking (NNS) is a coordinated motor skill
that can be taught through an educational activity that conditions neuronal responses through
positive reinforcement.The 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
newborn.The 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 infant.On 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 therapist's 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
intake.Infants 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.
