Effectiveness of Music Therapy on the Development of Preterm Neonates
Effectiveness of Music Therapy on the Development of Preterm Neonates
Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in
 order to estimate the effectiveness, six (6) months after hospital discharge, of music
 therapy on the intra-hospital evolution and neurodevelopment of preterm neonates (gestational
 ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in the
 Bucaramanga Metropolitan Area.
This is a pragmatic, randomized controlled clinical trial with blinding of the evaluator,
 performed in order to estimate the effectiveness, six (6) months after hospital discharge, of
 music therapy on the intra-hospital evolution and neurodevelopment of preterm neonates
 (gestational ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in
 the Bucaramanga Metropolitan Area.

 The study population is premature neonates at gestational ages 28 to 37 weeks who are treated
 in Neonatal Intensive Care Units (NICU). They will receive an intra-hospital music therapy
 intervention and will be compared to premature neonates in the same unit who will receive an
 intervention without sound emissions. The purpose is to identify differences in the behavior
 of clinical parameters at the intra-hospital level as well as in neurodevelopment six (6)
 months after hospitalization.

 To begin recruitment for the study, a neonatologist will contact the father/mother or legal
 representative and will briefly explain the purpose of the study and its procedures. After
 this, if the father/mother or legal representative is interested in allowing the neonate to
 participate, they will be put in contact with the physiotherapist coordinating the study who
 will fully explain the research. The neonate's participation in the study will be confirmed
 by an informed consent form signed by the parents. Each subject will be randomly assigned to
 an intervention group (music therapy or no sound emissions) based on a previously generated
 random numbers table. The person who possesses this table will indicate to the project
 coordinator via telephone the group to which each neonate is assigned, which will be
 stratified according to the healthcare clinic.

 Since this is a pragmatic trial, given the nature of the intervention, before the trial the
 mother will need to decide which of three music therapy options she would like her child to
 receive: her favorite song which she will sing, her favorite song which is obtained
 externally or a lullaby. This process of choosing the song is done only when assigned to the
 music therapy group, but the parents or legal representative will be told that their child
 could be assigned to either of the two groups, with music therapy or without sound emissions.
 At no time during the interventions will the parents, representative or the health
 professionals know the group to which the preterm neonate is assigned.

 The intervention will begin 24 hours after birth or when admitted to the clinic and will
 start by collecting the data requested on the admissions form. The sample will be composed of
 90 neonates, 45 of which will receive music therapy and 45 will receive intervention without
 sound emissions. This sample was estimated based on an alpha of 0.05 and a power of 0.9.

 The intervention parameters for volume intensity will be 55-65 decibels (db). The
 intervention will be performed by two physiotherapists who will alternate shifts to cover all
 the intervention days, since these two people will carry out the intervention on all of the
 days during which the infants will remain hospitalized. The exposure time will be 15 minutes
 per day. A mini baffle (JBL Bluetooth Go Brand) will be individually placed in a sealed
 sterile sleeve and put inside the incubator or on the top-center part of the crib aligned
 with the head of the neonate. The decibels will be measured with a Sonometer, which will be
 placed on the edge of the top access window on the right side of the incubator, facing in the
 direction of the neonate's ear.

 The variables to be registered for each intervention are: heart rate, respiratory rate,
 oxygen saturation and blood pressure. Each variable will be measured before the intervention,
 at 5, 10 and 15 minutes into the intervention, and 5 minutes after the intervention. During
 this time, the infant will be observed and any physical changes will be registered, including
 movement, crying, calming or anything that is different from the ordinary daily development
 of the neonate. When the infant is discharged (either to the pediatric intensive/intermediate
 care unit or home), a discharge report will be completed which will describe the clinical
 conditions under which the infant is leaving the unit. If the infant continues to be
 hospitalized in another unit, such as the pediatric/intermediate unit, he or she will receive
 the intervention until leaving the clinic, with the same parameters mentioned previously.

 In addition, a nurse in each unit (neonatal or pediatric) will register the changes from the
 previous day using a clinical monitoring data collection form, which includes the variables:
 relevant changes in vital signs, diagnoses, treatments, etc. (information obtained from the
 clinical chart or from the printed nursing report).

 All the measurement procedures will be standardized prior to application. The evaluators will
 be trained in the field using a pilot test, based on which the needed corrections will be
 applied. In addition, 10% of the measurements will be repeated or verified by the field
 coordinator. All the evaluators will be blinded to the intervention assignments and to the
 clinical status of the patients in order to prevent differential information bias.

 The father/mother, legal representative or medical team can decide to withdraw the infant
 from the study at any time and for any reasons they consider valid. The reason for withdrawal
 will be recorded on the last monitoring form that is completed.

 If the infant is discharged and on the next day is again hospitalized, and the Bayley III
 evaluation of the development of the infant has not yet been obtained, he or she will
 continue to receive the intervention in the hospital according to the protocol described by
 this study. If the Bayley III evaluation has been obtained and the infant returns to the
 clinic, the infant will not be treated because he or she would already be part of the next
 phase of the study, which involves the neurodevelopment of the infant.

 When the infant meets the criteria (corrected developmental age and is not hospitalized), the
 researcher shall immediately contact the father/mother or legal representative to perform a
 Bayley III evaluation of the development of the infant, which must be performed no later than
 six (6) days post-hospitalization. This evaluation will be conducted in the laboratories of
 the Manuela Beltran University (Gesell campus) under the following parameters: the evaluators
 (psychologist and physiotherapist) shall have at least 6 months of prior experience working
 with infants and will be trained in the use of this development scale prior to its
 application; the evaluators will be blinded to the type of intervention the infant is
 receiving; the evaluations (psychological and physiotherapeutic) will be performed
 simultaneously and the professionals will not be able to communicate among themselves during
 the intervention, and they will be recorded and monitored in order to ensure this condition
 is met; in addition, with no prior warning, the project coordinator will periodically monitor
 the evaluators through a one-way mirror located in the laboratory. The evaluators will
 electronically record the data on two laptop computers (using Bayley III software) located
 far away from each other in the laboratory, and will give an electronic and printed copy of
 the Bayley III evaluation form to the coordinator before leaving the laboratory. The two
 types of registries must agree, which will serve as a strategy to control the quality of the
 data. This evaluation will be repeated six months after hospitalization under the same
 conditions and by the same evaluators.

 During the first six months after hospitalization, the coordinator will call the parents or
 legal representative every 15 days, with four objectives: achieve adherence to the project,
 update contact data, identify the health conditions of the infant; and remind the parents or
 legal representative of the different check-ups that the child should receive during those
 six months.

 To this end, a general follow-up form will exist, which will contain the personal data of the
 infant and the father/mother or legal representative, the intensive care unit where he or she
 is treated, situations pertinent to the infant's condition, review of the dates of the
 post-hospitalization follow-up calls; review of completion of daily nursing forms,
 interventions, the 2 Bayley III evaluations, among others, in order to generate a database
 and to collect the data at the times established.

 To handle missing data, several imputation techniques will be considered based on the
 variables observed in the subject. In addition, the results obtained with and without the
 imputations will be compared to explore the effect of the missing values on the estimators. A
 sensitivity analysis will be performed if a high number of values for key variables are
 missing.

 For the statistical analysis, generalized linear regression models will be used for repeated
 measurements (with identity link function and normal distribution for the continuous
 responses and Log link function with negative binomial distribution for count responses).
 This will take into account the correlation structure within each subject and the
 time-intervention interactions. The existence of random slopes and intercepts will be
 explored. All the models will be compared with Akaike models and the model hypotheses will be
 verified. All analyses will be performed with STATA 14.
Inclusion Criteria:

 -  Belong to the group of neonates treated in neonatal intensive care units during the
 dates on which the sample will be taken.

 -  Clinical evaluation by the neonatologist indicating the infant's possible
 participation in the study.

 -  The neonate is between the gestational age of 28 and 37 weeks.

 Exclusion Criteria:

 -  Mother is not able to give consent due to mental incapacity.