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Efficacy of stochastic vibro-tactile stimulation for newborns at risk of neonatal opioid withdrawal syndrome

Pediatric Research (2025)Cite this article

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.

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Data availability

The de-identified dataset used for this study will be available from the corresponding author on reasonable request.

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Acknowledgements

The authors wish to thank the medical, nursing, and program staff; and the children and families participating in this trial. The authors thank the Data and Safety Monitoring Board (Dr. Vincent Smith, Dr. Elizabeth Yen, and Mr. Benjamin Sweigart). The authors also specifically want to acknowledge the contributions of Mr. John Konsin and Mr. David Morrill of Prapela Inc., for the technological support in manufacturing the study mattresses to specifications of the study protocol.

Funding

National Institutes of Health Small Business Innovation Research Program (SBIR) Grant, Award Number 2 R44 DA049300-02 (Singh, Konsin). The research was also supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UM1TR004398.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Tufts University School of Medicine, Boston, MA, USA

    Rachana Singh, Mario Cordova & Jonathan M. Davis

  2. Tufts Clinical and Translational Sciences Institute, Tufts University, Boston, MA, USA

    Ludovic Trinquart, Benjamin Koethe & Jonathan M. Davis

  3. Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA

    Ludovic Trinquart

  4. Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA

    Lawrence Rhein

  5. Department of Pediatrics, Cleveland Clinic, Cleveland, OH, USA

    Shawana Bibi

  6. Department of Pediatrics, Maine Medical Center, Portland, ME, USA

    Jamie Fey

  7. Department of Psychiatry and Behavioral Sciences, UCLA School of Medicine, Los Angeles, CA, USA

    Ariana Anderson

Authors
  1. Rachana Singh
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  2. Ludovic Trinquart
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  3. Benjamin Koethe
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  4. Mario Cordova
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  9. Jonathan M. Davis
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Contributions

RS and JD drafted the original manuscript and conceived and designed the study, contributed to data acquisition and analysis, and drafted the final manuscript. LT and BK contributed to data analysis; critically reviewed and revised the manuscript for intellectual content. MC, LR, SB, JF and AA contributed to data acquisition and analysis; critically reviewed and revised the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Rachana Singh.

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Competing interests

The authors declare no competing interests.

Consent statement

Written informed consent was obtained from parents prior to any study related intervention or completion of survey by the caregivers (nurses, parents).

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Singh, R., Trinquart, L., Koethe, B. et al. Efficacy of stochastic vibro-tactile stimulation for newborns at risk of neonatal opioid withdrawal syndrome. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04162-2

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