Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial

Abstract

Objective

To test whether stochastic vibrotactile stimulation (SVS) improved early weight trajectories in hospitalized term newborns with prenatal opioid exposure

Study design

This prospective, two-site randomized controlled trial compared days to lowest weight following birthweight [Nadir], maximal percent weight loss from birthweight [MaxLoss], days to return to birthweight [RtB], and weekly percent weight change from birth through the first month of life between infants who received treatment as usual (TAU) and infants who received SVS throughout hospitalization

Results

Among 181 term newborns [mean gestational age 39.0 ± 1.2weeks), no differences were observed between TAU (n = 87) and SVS (n = 94) for Nadir, MaxLoss, or RtB. Among symptomatic infants treated with morphine, mean weight gain at four weeks was significantly greater for SVS (29.88 ± 1.02%) than TAU (18.15 ± 7.31%; p < 0.05)

Conclusions

Among morphine-treated infants, the SVS cohort had greater early weight growth than the TAU cohort. Weight growthvelopmental outcomes in at-risk opioid-exposed newborns

Clinical Trial Registry

June 6, 2016, clinicaltrials.gov NCT02801331 (https://clinicaltrials.gov/study/NCT02801331)

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Subjects

• Outcomes research
• Paediatrics

Data availability

Deidentified data will be made available after publication to researchers who provide a methodologically sound proposal and abide by Institutional data access agreements. Requests should be submitted to Elisabeth Bloch-Salisbury while she is at salisburye2@upmc.edu

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Acknowledgements

The trial Data and Safety Monitoring Board, comprised of three external investigators with expertise in neonatal medical/clinical care, biostatistics, and neuropsychology, met with the research team twice a year, reviewed reports, and provided oversight of participant safety, data validity and integrity, and study conduct, progress, and efficacy. Dr. Debra L Bogen served as UPitt site principal investigator from 2016 to 2019. Barbara Glidden assisted in subject recruitment and data collection at UMass. The Wyss Institute at Harvard University (WIHU) provided some study mattresses and calibrations: James Niemi and Hani Sallum, with other engineers, built the prototype mattresses and mattress calibration system used at both sites. Mike Stone, with engineers at Cofab Design LLC, also constructed mattresses used in the trial. Dr. Mark Gartner and Jeff Speakman at UPitt Swanson School of Engineering constructed the mattress calibration system used at the UPitt site. James Niemi, Hani Sallum, and Kelsey Fafara at WIHU and Dr. Gartner and Kevin Xu at UPitt provided routine calibrations to help ensure mattress integrity throughout the trial. We thank the nurses in the infant units at UMass Memorial Health and UPMC Magee-Women’s Hospital for their logistical help, coordination, patience, and assistance in implementing this intricate study into the routine care of the infants. No financial compensation outside of salary was provided for these services. We gratefully acknowledge the infants and families for participating in this clinical trial.

Funding

This work was funded by the National Institute on Drug Abuse [R01DA042074 to Bloch-Salisbury] and the University of Massachusetts Research Trust Funds (to Bloch-Salisbury). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding organizations. The funding organizations had no role in the study design, data collection, analysis, decision to publish, or preparation, review, or approval of the manuscript

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Authors and Affiliations

1. Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

   Elisabeth Bloch-Salisbury, Sue R. Beers & James D. Wilson

2. Department of Pediatrics, UMass Chan Medical School, Worcester, MA, USA

   Elisabeth Bloch-Salisbury, Nicolas Rodriguez, Lauren McKenna, Matthew Derbin & Mark Vining

3. Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

   Tory Bruch & Toby Yanowitz

4. Department of Quantitative and Health Sciences, UMass Chan Medical School, Worcester, MA, USA

   Dane Netherton

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Contributions

Elisabeth Bloch-Salisbury: Conceptualization; Data curation; Formal analysis; Funding acquisition; Investigation; Methodology; Project administration; Resources; Software; Supervision; Validation; Visualization; Roles/Writing—original draft; and Writing—review and editing. Mr. Nicolas Rodriguez: Conceptualization; Data curation; Investigation; Methodology; Software; Supervision; Validation; Writing—review and editing. Tory Bruch: Data Curation; Investigation; Software; Validation; Writing—review and editing. Lauren McKenna: Data Curation; Investigation; Software; Validation; Writing—review and editing. Mr. Matthew Derbin: Data Curation; Investigation; Software; Validation; Writing—review and editing. Dane Netherton: Data Curation; Methodology; Project administration; Resources; Software; Validation; Writing—review and editing. Toby Yanowitz: Methodology; Project administration; Supervision; Writing—review and editing. Sue Beers: Conceptualization; Investigation; Methodology; Project administration; Supervision; Validation; Writing—review and editing. Mark Vining: Methodology; Project administration; Supervision; Writing—review and editing. James Wilson: Formal analysis; Resources; Software; Validation; Visualization; Writing—original draft; Writing—review and editing. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

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Competing interests

Dr. Bloch-Salisbury holds a patent for PCT/US2015/021999 licensed to Prapela Inc. Drs. Bloch-Salisbury, Wilson, and Beers are inventors on patent application PCT/US2025/051759 for stochastic vibrotactile stimulation to reduce weight faltering. The other authors have no competing interests to disclose

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Bloch-Salisbury, E., Rodriguez, N., Bruch, T. et al. Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial.
J Perinatol (2026). https://doi.org/10.1038/s41372-026-02862-z

• Received:05 November 2025

• Revised:13 July 2026

• Accepted:31 July 2026

• Published:24 August 2026

• Version of record:24 August 2026

• DOI
  :https://doi.org/10.1038/s41372-026-02862-z