A randomized controlled trial protocol in modifying neuromotor behavior of hospitalized preterm neonates using multimodal stimulations: MMS trial

Abstract

PURPOSE: Noxious sensory inputs from the neonatal Intensive Care Unit (NICU) and lack of placental support negatively impact neuronal organization which has implications later in life. Evidence regarding early interventions (EI) on preterm neonates (PN) at high risk for developmental motor disorders is limited and inconclusive. This study focuses on neuromotor changes following Multimodal stimulations (MMS) with sensory and motor interventions among stable hospitalized PNs. METHODS: This single-center, non-blinded pre-test post-test control group study will recruit 60 PNs admitted to the Level II and III NICU of a recognized tertiary care teaching hospital by convenience sampling method into two groups by block randomization. Group A (n = 30) will receive MMS trial lasting for 30 minutes per session for five days per week, until discharge of the neonate from the NICU; Group B (n = 30) will receive regular lifesaving care from the NICU. Anthropometric evaluation, physiological status, and Infant Neurological International Battery (INFANIB) will be the outcome measures used to analyze the neuromotor behavioral modifications among the hospitalized PNs. All the outcome measures will be recorded at baseline, after every five days (to compare trajectories of scores between the groups), and at the end of the intervention at the time of discharge of neonate from the NICU. RESULTS: Demographic and outcome measures will be assessed for their normality using the Shapiro-Wilk test. Within and between-group comparisons will be analyzed by the repeated measures analysis of variance/Friedman test and independent t-test/Mann-Whitney U test respectively. CONCLUSION: MMS, which includes both sensory and motor interventions, will, to the best of the authors’ knowledge, be the first trial for modifying the neuromotor behavior of hospitalized PNs. If successful, the clinical effects of this protocol could be revolutionary in mitigating developmental impairments of PNs.