Impact of a Clinical Decision Support Alert on Informed Consent Documentation in the Neonatal Intensive Care Unit.

Background: Informed consent is necessary to preserve patient autonomy and shared decision-making, yet compliant consent documentation is suboptimal in the intensive care unit (ICU). We aimed to increase compliance with bundled consent documentation, which provides consent for a predefined set of common procedures in the neonatal ICU from 0% to 50% over 1 year. Methods: We used the Plan-Do-Study-Act model for quality improvement. Interventions included education and performance awareness, delineation of the preferred consenting process, consent form revision, overlay tool creation, and clinical decision support (CDS) alert use within the electronic health record. Monthly audits categorized consent forms as missing, present but noncompliant, or compliant. We analyzed consent compliance on a run chart using standard run chart interpretation rules and obtained feedback on the CDS as a countermeasure. Results: We conducted 564 audits over 37 months. Overall, median consent compliance increased from 0% to 86.6%. Upon initiating the CDS alert, we observed the highest monthly compliance of 93.3%, followed by a decrease to 33.3% with an inadvertent discontinuation of the CDS. Compliance subsequently increased to 73.3% after the restoration of the alert. We created a consultant opt-out selection to address negative feedback associated with CDS. There were no missing consent forms within the last 7 months of monitoring. Conclusions: A multi-faceted approach led to sustained improvement in bundled consent documentation compliance in our neonatal intensive care unit, with the direct contribution of the CDS observed. A CDS intervention directed at the informed consenting process may similarly benefit other ICUs.

Implicit Racial Bias in Evaluation of Neonatal Opioid Withdrawal Syndrome.

OBJECTIVE: To assess implicit bias by administrating the Modified Finnegan Score (MFS) for quantifying neonatal opioid withdrawal and to evaluate risk of decreased opioid treatment of Black versus White infants. STUDY DESIGN: Study participants were nurses recruited from a large tertiary care center who received three clinical vignettes portraying withdrawing infants and were randomized to receive an accompanying photo of either a Black or White infant. MFS results were compared for identical vignettes based on race of infant photo. RESULTS: Out of 275 nurses, 70 completed the survey. In vignette 2, nurses aged ≤35 years scored Black infants lower than White infants (MFS=8.3 ± 2 vs. 9.5 ± 1.2, p=0.012). Nurses with <5 years of experience and ≤10 years of experience also scored Black infants lower for the same vignette (8.2 ± 2.3 vs. 9.6 ± 1.2, p=0.032 and 8.3 ± 2 vs. 9.5 ± 1.2, p=0.0083). CONCLUSION: Implicit bias may contribute to the difference in opioid treatment.

Predicting Heterogeneity in Patient Response to Morphine Treatment for Neonatal Opioid Withdrawal Syndrome.

Infants with neonatal opioid withdrawal syndrome commonly receive morphine treatment to manage their withdrawal signs. However, the effectiveness of this pharmacotherapy in managing the infants' withdrawal signs vary widely. We sought to understand how information available early in infant monitoring can anticipate this treatment response, focusing on early modified Finnegan Neonatal Abstinence Scoring System (FNASS) scores, polygenic risk for opioid dependence (polygenic risk score (PRS)), and drug exposure. Using k-means clustering, we divided the 213 infants in our cohort into 3 groups based on their FNASS scores in the 12 hours before and after the initiation of pharmacotherapy. We found that these groups were pairwise significantly different for risk factors, including methadone exposure, and for in-hospital outcomes, including total morphine received, length of stay, and highest FNASS score. Whereas PRS was not predictive of receipt of treatment, PRS was pairwise significantly different between a subset of the groups. Using tree-based machine learning methods, we then constructed network graphs of the relationships among these groups, FNASS scores, PRS, drug exposures, and in-hospital outcomes. The resulting networks also showed meaningful connection between early FNASS scores and PRS, as well as between both of those and later in-hospital outcomes. These analyses present clinicians with the opportunity to better anticipate infant withdrawal progression and prepare accordingly, whether with expedited morphine treatment or non-pharmacotherapeutic alternative treatments.

Effects of semi-upright swings on vital signs in NICU infants.

BACKGROUND: The aim of this study was to compare the impact of a semi-upright swing with a standard crib on vital signs in infants in the neonatal intensive care unit (NICU). METHODS: We performed a within-subjects' comparison of vital signs of NICU infants corrected to ≥34 weeks of gestation and placed in the supine position versus the semi-upright position in a swing. The primary outcome was the mean oxygen saturation, and the secondary outcomes were the mean heart rate, the proportion of time with oxygen saturation (SpO2) <90%, and respiratory rate. RESULTS: Of the 65 infants, 34 (57%) were male and 32 (50%) were black. The mean ± SD gestational age at birth was 32.4 ± 5.1 weeks. In all, 40% were on noninvasive respiratory support. There were no significant differences in oxygen saturation, heart rate, time with oxygen desaturation defined by SpO2 < 90%, or respiratory rate between the supine and semi-upright positions. A higher risk of desaturations was observed in infants without respiratory support (RR, 1.24, 95% CI, 1.15-1.33) and low-birth-weight infants (RR, 1.55, 95% CI, 1.42-1.69). CONCLUSIONS: The placement of infants in a semi-upright swing resulted in no discernible differences in averaged vital signs compared to the supine position in NICU infants. IMPACT: We identified no significant differences in averaged oxygen saturation, heart rate, or respiratory rate among NICU infants placed in a semi-upright swing compared to the supine position. Desaturation events occurred at a higher frequency in low-birth-weight infants and those on room air when placed in the swing, although none required oxygen supplementation. The results from the current study support that it is probably safe to use semi-upright swings in the NICU environment, although additional studies are necessary for generalization to the unmonitored home environment.

Alterations in motor functional connectivity in Neonatal Hypoxic Ischemic Encephalopathy.

BACKGROUND: Neonatal hypoxic-ischemic encephalopathy (HIE) is the result of global hypoxic-ischemic brain injury in neonates due to asphyxia during birth and is one of the most common causes of severe, long-term neurologic deficits in children. Methods: Resting state fMRI (rs-fMRI) was used to assess potential functional disruptions in the primary and association motor areas in HIE neonates (n = 16) compared to healthy controls (n = 11). RESULTS: Results demonstrate reduced intra-hemispheric resting state functional connectivity (rs-FC) between primary motor regions (upper extremity and facial motor regions) as well as reduced inter-hemispheric rs-FC in the HIE group. In addition, HIE neonates demonstrated increased rs-FC between motor regions and frontal, temporal and parietal cortices but decreased rs-FC with the cerebellum. DISCUSSION: These preliminary results provide initial evidence for the disruption of functional communication with the motor network in neonates with HIE. Further studies are necessary to both validate these findings in a larger dataset as well as to determine if rs-fMRI measurements collected at birth may have the potential to serve as a prognostic marker in addition to the traditional combination of clinical measurements and conventional MRI.

Tracheostomy on infants born in the periviable period: Outcomes at discharge from the neonatal intensive care unit (NICU).

OBJECTIVES: Advances in neonatal intensive care have allowed successful resuscitation of children born at the border of viability. However, there has been little change in the incidence of bronchopulmonary dysplasia (BPD) and anatomical upper airway obstruction which may require a tracheostomy in that group. The benefits of the procedure are accompanied by sequelae that impact outcomes. Information about these issues can assist caregivers in making decisions and planning care after discharge from the neonatal intensive care unit (NICU). The objectives of this study were to describe the clinical characteristics of neonates born in the periviable period (≤25 weeks gestation) requiring tracheotomy and to highlight their hospital course, complications and status upon NICU discharge. METHODS: Retrospective analysis at four tertiary care academic children's hospitals. Medical records of neonates born ≤25 weeks gestation who required tracheotomy between January 1, 2012 and December 31, 2018 were reviewed. Demographics, medical comorbidities, and tracheostomy related complications were studied. Feeding, ventilation, and neurodevelopmental outcomes at time of transfer from NICU were evaluated. RESULTS: Fifty-two patients were included. The mean gestational age was 24.3 (95% confidence interval, 24.1 to 24.5) weeks. The mean birth weight was 635 (95% CI: 603 to 667) grams and 50 (96.2%) children had BPD. At time of discharge from the NICU, 47 (90.4%) required mechanical ventilation, four (7.7%) required supplemental oxygen and one (1.9%) was weaned to room air. Forty-two (80.8%) were discharged with a gastrostomy tube, seven (28%) with a nasogastric tube, and three (5.8%) were on oral feeds. Two (3.8%) suffered hypoxic ischemic encephalopathy, 27 (51.9%) had neurodevelopmental delay, seven (13.5%) were diagnosed with another anomaly, and 16 (30.8%) were considered normal. Complications related to the procedure were observed in 28 (53.8%) neonates. Granulation tissue was seen in 17 (32.7%), wound break down or cellulitis in three (5.8%), one (1.9%) with tracheostomy plugging, three (5.8%) with dislodgement of the tracheostomy tube and four (7.7%) developed tracheitis. CONCLUSIONS: Tracheostomy in infants born in the periviable period is primarily performed for BPD and portends extended ventilatory dependence. It is associated with non-oral alimentation at the time of discharge from the NICU and developmental delay. Mortality directly related to the procedure is rare. Minor complications are common but do not require surgical intervention. These data may aid in counseling caregivers about the procedure in this vulnerable population.

Sentinel bowel loop as a marker for primary segmental intestinal volvulus in extreme low birth weight neonates.

Primary segmental intestinal volvulus is a rare condition that may affect neonates. This condition occurs when a loop of bowel torses around the axis of its mesentery without any other abnormality or malrotation. In the earlier stages, the diagnosis can be challenging due to the lack of specific clinical and radiographic signs. Prompt surgical management is critical as a delay in diagnosis may result in bowel loss or death. We present a series of three cases of extremely low birth weight infants with primary segmental volvulus. A sentinel bowel loop was critical in guiding each patient's surgical management as there were no other clinical markers concerning a pending intra-abdominal catastrophe. This case series suggests that a sentinel bowel loop may be a radiographic marker for primary segmental intestinal volvulus in extremely low birth weight infants.

Enduring consequences of perinatal fentanyl exposure in mice.

Opioid use by pregnant women is an understudied consequence associated with the opioid epidemic, resulting in a rise in the incidence of neonatal opioid withdrawal syndrome (NOWS) and lifelong neurobehavioral deficits that result from perinatal opioid exposure. There are few preclinical models that accurately recapitulate human perinatal drug exposure and few focus on fentanyl, a potent synthetic opioid that is a leading driver of the opioid epidemic. To investigate the consequences of perinatal opioid exposure, we administered fentanyl to mouse dams in their drinking water throughout gestation and until litters were weaned at postnatal day (PD) 21. Fentanyl-exposed dams delivered smaller litters and had higher litter mortality rates compared with controls. Metrics of maternal care behavior were not affected by the treatment, nor were there differences in dams' weight or liquid consumption throughout gestation and 21 days postpartum. Twenty-four hours after weaning and drug cessation, perinatal fentanyl-exposed mice exhibited signs of spontaneous somatic withdrawal behavior and sex-specific weight fluctuations that normalized in adulthood. At adolescence (PD 35), they displayed elevated anxiety-like behaviors and decreased grooming, assayed in the elevated plus maze and sucrose splash tests. Finally, by adulthood (PD 55), they displayed impaired performance in a two-tone auditory discrimination task. Collectively, our findings suggest that perinatal fentanyl-exposed mice exhibit somatic withdrawal behavior and change into early adulthood reminiscent of humans born with NOWS.

Role of diffusion-weighted imaging in prediction of nipple-areolar complex invasion by breast cancer.

THE AIM OF THIS WORK: The aim of this work was to estimate the role of diffusion-weighted imaging (DWI) in predicting malignant invasion of the nipple-areolar complex (NAC) by underlying breast cancer. MATERIAL AND METHODS: This prospective study included 70 female patients with breast cancer with a mean age of 45.8 years (range: 28-68). DWI of the breast was done for all patients. Apparent diffusion coefficient (ADC) maps were automatically constructed. The mean ADC values of NAC were independently measured by two observers who are experts in breast imaging and correlated with the results of histopathological examinations. RESULTS: Both observers found a significantly lower ADC value of malignant NAC invasion (n = 18) when compared with free NAC (n = 52), with mean ADC value for malignant NAC invasion was 0.86 ± 0.35 × 10-3 mm2/s and 0.84 ± 0.08 × 10-3 mm2/s for observer one and two respectively versus mean ADC value of 1.34 ± 0.25 × 10-3 mm2/s and 1.4 ± 0.26 × 10-3 mm2/s for free NAC by observer one and two respectively (P-value =0.001). Observer one found that a cutoff ADC value of 1.05 × 0-3 mm2/s can predict malignant NAC invasion with 0.975 AUC, 92.8% accuracy, 94.4% sensitivity, and 92.3% specificity. Observer two found that a cutoff ADC value of 0.95 × 10-3 mm2/s can predict malignant NAC invasion with 0.992 AUC, 95.7% accuracy, 88.9% sensitivity, and 98.1% specificity. CONCLUSION: DWI can predict malignant NAC invasion in patients with breast cancer.

Model-Based Approach to Improve Clinical Outcomes in Neonates With Opioid Withdrawal Syndrome Using Real-World Data.

At least 60% of the neonates with opioid withdrawal syndrome (NOWS) require morphine to control withdrawal symptoms. Currently, the morphine dosing strategies are empiric, not optimal and associated with longer hospital stay. The aim of the study was to develop a quantitative, model-based, real-world data-driven approach to morphine dosing to improve clinical outcomes, such as reducing time on treatment. Longitudinal morphine dose, clinical response (Modified Finnegan Score (MFS)), and baseline risk factors were collected using a retrospective cohort design from the electronic medical records of neonates with NOWS (N = 177) admitted to the University of Maryland Medical Center. A dynamic linear mixed effects model was developed to describe the relationship between MFS and morphine dose adjusting for baseline risk factors using a split-sample data approach (70% training: 30% test). The training model was evaluated in the test dataset using a simulation based approach. Maternal methadone and benzodiazepine use, and race were significant predictors of the MFS response. Positive autocorrelations of 0.56 and 0.12 were estimated between consecutive MFS responses. On an average, for a 1,000 µg increase in the morphine dose, the MFS decreased by 0.3 units. The model evaluation showed that observed and predicted median time on treatment were similar (13.0 vs. 13.8 days). A model-based framework was developed to describe the MFS-morphine dose relationship using real-world data that could potentially be used to develop an adaptive, individualized morphine dosing strategy to improve clinical outcomes in infants with NOWS.

Research: Replacing Overhead Paging with Smartphones to Reduce Hospital Noise.

Hospital noise is associated with adverse effects on patients and staff. Communication through overhead paging is a major contributor to hospital noise. Replacing overhead paging with smartphones through a clinical mobility platform has the potential to reduce transitory noises in the hospital setting, though this result has not been described. The current study evaluated the impact of replacing overhead paging with a smartphone-based clinical mobility platform on transitory noise levels in a labor and delivery unit. Transitory noises were defined as sound levels greater than 10 dB above baseline, as recorded by a sound level meter. Prior to smartphone implementation, 77% of all sound levels at or above 60 dB were generated by overhead paging. Overhead pages occurred at an average rate of 3.17 per hour. Following smartphone implementation, overhead pages were eliminated and transitory noises decreased by two-thirds (P < 0.001). The highest recorded sound level decreased from 76.54 to 57.34 dB following implementation. The percent of sounds that exceeded the thresholds recommended by the Environmental Protection Agency and International Noise Council decreased from 31.2% to 0.2% following implementation (P < 0.001). Replacement of overhead paging with a clinical mobility platform that utilized smartphones was associated with a significant reduction in transitory noise. Clinical mobility implementation, as part of a noise reduction strategy, may be effective in other inpatient settings.

High concentrations of urinary ethanol metabolites in neonatal intensive care unit infants.

BACKGROUND: Infants in the neonatal intensive care unit may be exposed to ethanol via medications that contain ethanol as an excipient and through inhalation of ethanol vapor from hand sanitizers. We hypothesized that both pathways of exposure would result in elevated urinary biomarkers of ethanol. METHODS: Urine samples were collected from infants in incubators and in open cribs. Two ethanol metabolites, ethyl sulfate (EtS) and ethyl glucuronide (EtG), were quantified in infants' urine. RESULTS: A subset of infants both in incubators and open cribs had ethanol biomarkers greater than the cutoff concentration that identifies adult alcohol consumption. These concentrations were associated with the infant having received an ethanol-containing medication on the day of urine collection. When infants who received an ethanol-containing medication were excluded from analysis, there was no difference in ethanol biomarker concentrations between the incubator and crib groups. CONCLUSIONS: Some infants who received ethanol-containing medications had concentrations of ethanol biomarkers that are indicative of adult alcohol consumption, suggesting potential exposure via ethanol excipients. IMPACT: Infants and newborns in the neonatal intensive care unit are exposed to concerning amounts of ethanol. No one has shown exposure to ethanol in these infants before this study. The impact is that better understanding of the excipients in medications given to patients in the NICU is needed. When physicians order medications in the NICU, the amount of excipient needs to be indicated.

Research: Parental Perceptions on Smartphone Use for Clinical Mobility.

Smartphones increasingly are used to facilitate the delivery of healthcare. Earlier studies assessing patient perceptions on smartphone use were performed before the emergence of broad clinical mobility platforms, and these studies did not distinguish potential differences related to smartphone device types. The current study evaluated the perceptions of neonatal intensive care unit parents on two different smartphone devices (personal phone and industrial phone) in the setting of an established clinical mobility platform. A total of 59 parents completed a multiple-choice survey exploring respondents' beliefs regarding whether smartphones could help care for their child, concerns regarding privacy/security, and perceived functionality of each smartphone. For both devices, most participants believed that smartphones were clearly used to help in the care of their child. However, respondents reported greater comfort with the industrial phone (P < 0.05). Respondents were more likely to express concern that the personal phone could compromise their child's personal/private information (P < 0.05). Respondents were more likely to believe that the industrial phone could receive emergency alerts/alarms compared with the personal phone (P < 0.05). Parental perceptions of smartphones generally were positive; however, perceived differences were found between devices, and smartphone functionality was underestimated. This suggested that education interventions addressing the value of smartphones for clinical mobility are warranted.

Mercury, lead, and cadmium exposure via red blood cell transfusions in preterm infants.

BACKGROUND: Mercury, lead, and cadmium are developmental neurotoxicants. We predict that preterm newborns requiring packed red blood cell (PRBC) transfusions may be exposed to neurotoxic doses. We explored the relationship between donor concentration, number of donors, number of transfusions and mercury, lead and cadmium exposure. METHODS: Single-donor PRBCs were analyzed for mercury, lead and cadmium concentration. Dose per transfusion was calculated and compared to intravenous reference doses (IVRfDs). Linear regression analyses were performed to correlate donor and infant exposure. RESULTS: Thirty-six infants received 268 transfusions from 94 donors. Number of donors and transfusions were significantly correlated with birthweight and gestational age. All three metals were detected in ≥95% of donor PRBCs. Number of donors was significantly associated with cumulative dose, and there was a significant correlation between mercury and lead doses/transfusion. IVRfDs were exceeded for mercury and lead in 8.6% and 38% of transfusions, respectively. None exceeded the IVRfD for cadmium. For lead, infants exposed to three donors had more transfusions exceeding IVRfD than those exposed to 1-2 donors. CONCLUSIONS: Preterm infants are exposed to heavy metals via transfusions. Doses exceeded the IVRfDs for mercury and lead. Cadmium did not pose a risk. Prescreening donor blood could reduce exposure risk.