Effectiveness of Music Therapy on the Intra-hospital Evolution and Neurodevelopment of Preterm Neonates Treated in Neonatal Intensive Care Units 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.