Effectiveness of Indian classical music on developmental responses of preterm infants - A randomized controlled trial protocol

Background: The highly sophisticated Neonatal Intensive Care Unit (NICU) exposes preterm infants to constant unexpected stimuli especially noise, impacting their growth and development. Modifying the environment of the NICU by provision of patterned stimuli like music is essential. There is a paucity of data from large and well-conducted trials on Indian Classical music, which limit the evidence for use of music as therapy for preterm infants.Methodology: A randomized controlled trial with repeated measures design will be conducted. A sample size of 132 preterm infants who are admitted to the NICU, will be assessed for eligibility to be included in the study. The parent(s) of the preterm infants will be approached for informed proxy consent. A study assistant will manage the allocation of participants and the provision of the intervention independently. The investigators who perform the outcome assessment will be blinded to the allocation of participants to the intervention and control arm of the study.Outcome measures will be assessed at baseline (day 3 of life). Following the administration of the intervention in the experimental group, the outcome measures will be assessed after completion of one week of intervention (day 10 of life) and after completion of two weeks of intervention (day 17 of life)