Efficacy of a Gentle Vibrating Crib Mattress for Reducing Pharmacological Treatment in Opioid-exposed Newborns

Elisabeth Bloch-Salisbury, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States; James D. Wilson, University of Pittsburgh School of Medicine, San Anselmo, CA, United States; Nicolas Rodriguez, Heinrich Heine University, United States; Tory Bruch, Des Moines University, IA, United States; Lauren McKenna, University of Massachusetts Chan Medical School, MA, United States; Matthew Derbin, University of Massachusetts Chan Medical School, United States; Barbara Glidden, University of Massachusetts Chan Medical School, United States; Didem Ayturk, University of Massachusetts Chan Medical School, United States; Sanjay Aurora, Mass General Brigham, United States; Lidush Goldschmidt, University of Pittsburgh Medical Center, United States; Toby D. Yanowitz, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States; Bruce Barton, University of Massachusetts Chan Medical School, United States; Sue Beers, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States; Mark Vining, University of Massachusetts Chan Medical School, United States; Debra L. Bogen, University of Pittsburgh School of Medicine, PA, United States

Background: Despite known adverse effects on neurobehavioral development, pharmacological agents are often used to treat newborns with prenatal opioid exposure (POE) when first line-strategies are not adequate to manage withdrawal symptoms and dysregulated behaviors. Alternative interventions are needed to treat newborns with POE.

Objectives: To examine the therapeutic efficacy of a gentle vibrating crib mattress as a complementary, non-pharmacological intervention for treating newborns with POE.

Design/Methods: This dual site randomized controlled trial (NCT02801331) studied 208 full term newborns with POE. Within 48 hours of birth, infants were assigned to either treatment as usual (TAU) or standard care plus stochastic vibratory stimulation (SVS) using a specially constructed crib mattress with a 3 hour on-off cycle throughout hospitalization. Regardless of condition assignment, infants with more severe symptoms who met pharmacologic treatment criteria were transferred to the neonatal intensive care unit (NICU) for morphine treatment per standard care.

Results: Analyses were performed on 181 newborns [mean gestational age 39.0 weeks (SD=1.2); mean birth weight 3076 grams (SD=489); 45% male; 92% white] who completed hospitalization at respective study site. Adjusting for site, birth sex, birth weight, opioid exposure, and feed type, infant daily average SVS duration was associated with a reduction in relative risk of receiving morphine treatment (RRT); [odds ratio=0.88 per hour/day, 95% CI: (0.86, 0.94)]. There was a 50% reduction in RRT for infants who received SVS on average 6 hours/day while in the newborn nursery. Among infants who were transferred to the NICU for morphine treatment and completed treatment within three weeks (n=32), those assigned to SVS completed treatment three times faster than those assigned to TAU [hazards ratio=3.0, 95% CI: (1.27, 7.15); Figure 1], corresponding to a 19% reduction (2.75 days) in length of treatment [95% CI: (0.3%, 34.6%)].

Conclusion: Findings indicate SVS may serve as a complementary non-pharmacological intervention for treating newborns with POE. Reduction in pharmacological treatment with SVS has implications for reduced hospitalization stays and costs, and possibly improved outcomes given known adverse effects of morphine on neurodevelopment.
Funded by NIDA R01DA042074 (EBS).