Abstract
BACKGROUND: Neonatal Opioid Withdrawal Syndrome (NOWS) continues to be a major public health burden. Our objective was to assess the efficacy of a stochastic vibro-tactile stimulation (SVS) mattress in reducing initiation of pharmacotherapy in neonates at risk for NOWS. METHODS: A multicenter, prospective, non-blinded, randomized clinical trial of neonates born ≥ 35 weeks gestation. Neonates randomized to either SVS mattress or standard crib mattress The outcomes examined were initiation of pharmacotherapy, readiness for discharge, NOWS monitoring scores, cry quality and mattress acceptability surveys. RESULTS: Of 62 infants enrolled, 4 infants (10.0%) in the SVS group and 4 infants (18.2%) in the standard group were initiated on pharmacotherapy. Infants in SVS group demonstrated early readiness for discharge, with no differences between the two groups for NOWS scoring or cry quality. Overall, 60% of nurses and 80% of parents found the SVS mattress helped calm the neonate. CONCLUSION: Although the SVS mattress demonstrated a trend towards lower initiation of pharmacotherapy and earlier readiness for discharge, the results were not statistically significant due to fewer neonates being enrolled than expected. The mattress was highly acceptable to parents and nurses. CLINICAL TRIAL: Registered at ClinicalTrials.gov ID # NCT04834297; https://clinicaltrials.gov/study/NCT04834297 IMPACT: Improving on current non-pharmacologic interventions for the prevention and treatment of Neonatal Opioid Withdrawal Syndrome (NOWS) is critically important. Our study focused on assessing the efficacy of a stochastic vibro-tactile stimulation (SVS) mattress in reducing the use of pharmacotherapy in neonates at risk for NOWS within the first 5 days after birth. In neonates at risk for NOWS, the SVS mattress may reduce the need for pharmacotherapy and improve readiness for discharge while being acceptable to parents and nurses.