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A crib mattress designed to vibrate gently for tactile sensory stimulation eased neonatal opioid withdrawal syndrome, reducing need for pharmacologic treatment, a randomized clinical trial showed.

This low-level random, or stochastic, vibrotactile stimulation (SVS) didn't reduce the number of newborns receiving morphine treatment (30.9% vs 35.6% with usual care, P=0.60).

However, the average of 6 hours per day of use did cut administration of morphine treatment by a relative 50%, researchers led by Elisabeth Bloch-Salisbury, PhD, of the University of Pittsburgh School of Medicine, .

After adjusting for study site, infant sex, birth weight, opioid exposure, and feed type, longer duration of SVS lowered the administration of morphine treatment (OR 0.88 hours per day, 95% CI 0.81-0.93). That effect was on par with time spent being held by caregivers (OR 0.90 hours per day, 95% CI 0.86-0.94) and appeared additive to it.

"While there is no replacement for natural touch by a caregiver to an infant, given that caregivers are not always available to hold infants in the hospital setting, SVS may provide a beneficial intervention to promote health equity and improve clinical outcomes among vulnerable newborns with POE [prenatal opioid exposure]," the researchers concluded.

The findings follow on the heels of the ACT NOW randomized trial, which showed that a newer function-based approach to treating neonatal opioid withdrawal syndrome safely readied infants to go home from the hospital sooner. The Eat, Sleep, Console care approach decreased the proportion of infants who received pharmacologic (often opioid) treatment by 32.5 percentage points, as .

"Newborns with prenatal opioid exposure are commonly treated with opioids and other medications to manage withdrawal and wean from dependence," Bloch-Salisbury told 番茄社区 in an email. "However, prenatal exposures may have neurodevelopmental consequences that may not be addressed by medications prescribed for withdrawal. Furthermore, opioid medications, such as morphine, used to treat withdrawal may further exacerbate neurodevelopmental outcomes. This is an important area of study because there is a great need to reduce medication treatment in this vulnerable population of infants."

Her group's study included 208 term newborns with POE enrolled at the University of Massachusetts between March 9, 2017 and Feb. 25, 2020, and at the University of Pittsburgh between Aug. 18, 2017, and March 10, 2020, they reported. Written informed consent was obtained from the biological mother of each infant either prenatally or within 48 hours of delivery.

The infants were studied at their bedside throughout hospitalization. Half of the cohort were randomized to treatment as usual, while the other half received standard care plus SVS using the crib mattress with a 3-hour on-off cycle.

Analyses were performed on 181 infants who completed hospitalization at their study site. Of the 27 who did not complete hospitalization, 14 were withdrawn from the study and 13 were transferred to another hospital.

Among infants who were transferred to the neonatal intensive care unit (NICU) for morphine treatment and who completed treatment within 3 weeks, those who received SVS finished treatment nearly twice as fast (HR 1.96, 95% CI 1.01-3.81). This resulted in a significant 3.18 fewer treatment days for the SVS group and a mean of 1.76 mg/kg (95% CI -3.02 to -0.50) less morphine received. However, there were no effects observed among infants treated for more than 3 weeks.

Among other findings, infants with prenatal methadone exposure had a higher rate of administration of morphine treatment (OR 2.30, 95% CI 1.15-4.62), as well as a higher cumulative morphine dose (mean 2.48 mg/kg, 95% CI 1.14-3.82) and significantly longer length of treatment than infants of mothers receiving buprenorphine therapy. However, there were no interactions between methadone exposure and condition.

"Creative strategies like this are really exciting, and I think the encouraging results are likely to be welcomed by families [who] often prefer minimal pharmacological treatment for young babies," said Clare McCormack, PhD, assistant professor in the Department of Child and Adolescent Psychiatry at NYU Grossman School of Medicine in New York City, who was not involved in the research.

The fact that the study was a randomized trial strengthens the findings, she told 番茄社区.

McCormack added that she would be interested to see whether the intervention might also be effective for infants in the NICU for other reasons, since in general parental holding can be difficult in this setting.

Limitations of the study included that it was conducted at the bedside in the hospital setting, with infants monitored continuously whether they were in the nursery, with the mother or family in a private room, in a NICU open pod, or being wheeled between locations, Bloch-Salisbury and colleagues noted. Additionally, the research team relied on computer log reports by caregivers (medical, family, or research) as to when the infant was in the crib.

Further limitations included that there was concern for potential bias in caregiver assessments, and that the research team did not test the effectiveness of SVS as an alternative to medication, they added.

"Additional studies are needed to ascertain the effectiveness of stochastic vibrotactile stimulation as an alternative to pharmacological treatment," Bloch-Salisbury said. "It will be important for future studies to identify infants who may be more responsive to stochastic vibrotactile stimulation and/or treatment medications."

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