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

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 growth via SVS has implications for reduced morbidities and improved developmental outcomes in at-risk opioid-exposed newborns. CLINICAL TRIAL REGISTRY: June 6, 2016, clinicaltrials.gov NCT02801331 ( https://clinicaltrials.gov/study/NCT02801331 ).