This study revealed implementation of a novel bassinet failed to enhance non-pharmacologic management of infants with NAS admitted to an open-bay NICU. The novel bassinet was significantly associated with an increased length of hospitalization and exposure to pharmacologic treatment of our NAS study population. These findings were contrary to our original hypothesis that the novel bassinet would decrease LOS and pharmacologic exposure. It was presumed the unique features of the novel bassinet would collectively act as an effective NPI for NAS, especially in an open-bay NICU. Its ability to adjust the intensity of rocking to the infant’s intensity of agitation was a characteristic presumed to benefit vestibular sensory stimulation that has increasingly been suggested to improve behavioral responses of infants with intrauterine drug exposure (15–19).
Prior examples of altering the proximal environment using various modified bassinet mattresses have shown benefits in the non-pharmacologic management of infants with opioid withdrawal. Oro and Dixon described benefits of implementing a commercially available non-oscillating waterbed for non-pharmacologic management of infants with NAS (20). Those infants placed on a waterbed mattress required significantly less pharmacologic treatment and had lower withdrawal scores and earlier consistent weight gain compared to controls. The authors attributed the findings as a favorable behavioral response to proximal tactile and vestibular stimuli input provided by the non-oscillating waterbed upon movement by the infant.
In a recent randomized study by Bloch-Salsbury et al., a vibrating crib mattress with a continuous three-hour on-off cycle of low stochastic vibrotactile stimulus (SVS) was compared to a standard bassinet mattress for treatment of newborns with prenatal opioid exposure (21). Infants were randomized to the SVS mattress or standard bassinet mattress in the newborn nursery where they remained until transferred to the NICU for pharmacologic treatment or discharged home. They found daily duration of SVS was associated with a 50% reduction in the need for morphine compared to controls. Also, infants who received SVS and required less than three weeks of morphine treatment had fewer treatment days and less cumulative morphine dose compared to controls. Sub-analysis of caretaker bedside logs found caretaker holding time reduced the need for morphine administration equivalent to SVS. The authors concluded greater exposure to tactile stimulation, whether SVS vibration of holding by caretakers, resulted in less need for pharmacologic treatment and that mechanosensory stimulation provided by direct human contact or SVS appeared to reduce NAS withdrawal symptoms.
Explaining why the commercially available horizontal rocking bassinet used in our study failed to enhance non-pharmacologic management of prenatally opioid exposed infants is a challenge. When comparing devices, they each employ different motion effects that could result in different tactile, proprioceptive, and vestibular inputs. Oro and Dixon used a non-oscillating waterbed that upon infant movement provided direct conforming tactile and vestibular input (20). Alternatively, the mattress used in the study by Bloch-Salsbury et al. provided a three-hour on-off cycle of low-intensity random vibrotactile stimulation (21). The commercially available novel bassinet used in this study provided a horizontal motion that intensified as an infant became more agitated. Based on our findings, it is possible subjecting NAS infants to a specific type, duration, and intensity of motion may result in adverse instead of beneficial tactile and vestibular sensory input and limit the management of these patients.
Interestingly, in 1999 Karen D’Apolito compared the use of a mechanical rocking bed to a standard bassinet for drug-affected infants (22). Infants randomized to the rocking bassinet had increased withdrawal symptoms, sleep deprivation, and suboptimal neurobehavioral function on day of life seven as defined by lower cluster scores on the Brazelton Neonatal Behavioral Assessment Scale (22). The authors suggested the ineffectiveness of the rocking bed possibly was related to excessive stimulation during the acute phase of infants experiencing withdrawal from prenatal opioid exposure (22). Similarly, excessive stimulation may hold true as an explanation for the ineffectiveness of the novel bassinet utilized in this study.
The novel bassinet used in our study is available commercially and traditionally targeted at healthy infants in the first six months of life to enhance sleep and decrease agitation. The novel bassinet has not been specifically studied or marketed as a device to assist in non-pharmacologic management of infants exposed to opioids in utero. It was our hypothesis that disorganized sleep and agitation characteristic of NAS may be similar to that of non-opioid exposed infants and these infants would potentially benefit from use of the novel bassinet. However, the novel bassinet in our study failed to have any significant effect on Finnegan crying or sleeping scores. How non-opioid exposed infants versus those with NAS process and respond to various tactile and vestibular stimuli is beyond the scope of this study but our results and those discussed suggest infants with NAS respond differently to position and specific type, duration, and intensity of motion.
Our Occupational Therapy (OT) colleagues were first to voice concerns regarding study participants placed in the novel bassinet. They were troubled by the length of time NAS infants assigned to the novel bassinet were swaddled and kept supine. Supine position is compliant with the 2022 American Academy of Pediatrics recommendation for safe sleep, but Maichuk et al., found infants exposed prenatally to opioids had improved sleep patterns, decreased activity, stabilization of respirations and heart rate, and lower NAS scores with prone positioning (11, 23). With an unknown contribution to outcome, periods of prone positioning did occur for infants managed in Group 1 (control group) and Group 2 (NPI), but not Group 3 (NPI + Novel Bassinet). Swaddling methods while using the novel bassinet were also of concern and restricted self-soothing behavior by inhibiting the ability of the infant to direct hands to their mouth. Lastly, it was questioned if the intensity and horizontal direction of motion would adversely affect vestibular input and development of self-soothing behaviors. As a result of our OTs’ concerns, an early review of our data occurred before completion of the goal number of novel bassinet patients and prompted us to discontinue the study.
The pre- and post-nursing survey of the novel bassinet for the management of NAS infants also indicated a neutral opinion regarding effectiveness. The majority of nurses that participated in the survey found ancillary staff and volunteers more helpful in decreasing nursing time spent soothing and consoling infants compared to the novel bassinet. Our survey results contrast with those recently published by Gellasch et al. regarding the same bassinet (24). Their survey indicated providers perceived the bassinet as supporting patient care, reducing provider stress, and saving caretakers an estimated 2.2 hours per shift. Their bassinet survey, however was not limited to prenatally opioid exposed infants but for differing clinical scenarios involving patients cared for in NICUs, pediatric intensive care units, and general hospital pediatric floors (24).
Limitations
There are significant limitations of our study. First, our patient sample size was less than desired with only 21 infants enrolled in Group 3 (NPI + novel bassinet) instead of the calculated sample size of 37 infants. This was in part a result of terminating the study early after a preliminary review of the data revealed an alarming increase in LOS, LOT, and morphine exposure in mg/kg for infants in Group 3. Additionally, infants were not randomized into study groups which may have increased biases regarding our results. A third limitation involved the nurse satisfaction survey regarding use of the novel horizontal rocking bassinet. We were unable to identify if pre- and post-test responses were from the same participants which may have also contributed to interpretation biases. We also do not have long term follow-up of our study population which would greatly validate our short-term outcomes and concerns.