Characterizing continuous positive airway pressure (CPAP) Belly Syndrome in preterm infants in the neonatal intensive care unit (NICU).

OBJECTIVE: Reproducibly define CPAP Belly Syndrome (CBS) in preterm infants and describe associated demographics, mechanical factors, and outcomes. STUDY DESIGN: A retrospective case-control study was conducted in infants <32 weeks gestation in the Stanford Children's NICU from January 1, 2020 to December 31, 2021. CBS was radiographically defined by a pediatric radiologist. Data analysis included descriptive statistics and comparator tests. RESULTS: Analysis included 41 infants with CBS and 69 infants without. CBS was associated with younger gestational age (median 27.7 vs 30 weeks, p < 0.001) and lower birthweight (median 1.00 vs 1.31 kg, p < 0.001). Infants with CBS were more likely to receive bilevel respiratory support and higher positive end expiratory pressure. Infants with CBS took longer to advance enteral feeds (median 10 vs 7 days, p = 0.003) and were exposed to more abdominal radiographs. CONCLUSIONS: Future CBS therapies should target small infants, prevent air entry from above, and aim to reduce time to full enteral feeds and radiographic exposure.

In Situ Simulation and Clinical Outcomes in Infants Born Preterm.

OBJECTIVE: To evaluate impact of a multihospital collaborative quality improvement project implementing in situ simulation training for neonatal resuscitation on clinical outcomes for infants born preterm. STUDY DESIGN: Twelve neonatal intensive care units were divided into 4 cohorts; each completed a 15-month long program in a stepped wedge manner. Data from California Perinatal Quality Care Collaborative were used to evaluate clinical outcomes. Infants with very low birth weight between 22 through 31 weeks gestation were included. Primary outcome was survival without chronic lung disease (CLD); secondary outcomes included intubation in the delivery room, delivery room continuous positive airway pressure, hypothermia (<36°C) upon neonatal intensive care unit admission, severe intraventricular hemorrhage, and mortality before hospital discharge. A mixed effects multivariable regression model was used to assess the intervention effect. RESULTS: Between March 2017 and December 2020, a total of 2626 eligible very low birth weight births occurred at 12 collaborative participating sites. Rate of survival without CLD at participating sites was 74.1% in March to August 2017 and 76.0% in July to December 2020 (risk ratio 1.03; [0.94-1.12]); no significant improvement occurred during the study period for both participating and nonparticipating sites. The effect of in situ simulation on all secondary outcomes was stable. CONCLUSIONS: Implementation of a multihospital collaborative providing in situ training for neonatal resuscitation did not result in significant improvement in survival without CLD. Ongoing in situ simulations may have an impact on unit practice and unmeasured outcomes.

Novel Umbilical Catheter Securement and Protection Device for Umbilical Line Securement during Laparotomy.

OBJECTIVE: Umbilical catheter malposition rate is high. We compared a Novel Umbilical Securement Device (NUSD) to standard methodologies for neonatal invasive care unit patients undergoing laparotomy. STUDY DESIGN: Retrospective study was performed on infants undergoing laparotomy from April 2019 to January 2023. Two neonatologists compared position of umbilical arterial catheter/umbilical venous catheter (UVC) on perioperative chest X-ray (CXRs) in patients with or without NUSD. RESULTS: Eighteen patients underwent laparotomy, of which 8 patients had NUSD (9 lines) and 10 patients did not (14 lines). In NUSD group, mean gestational age was 37 ± 4 weeks and mean birth weight was 2.3 ± 0.9 kg compared with 31 ± 8 weeks and 2.1 ± 1.4 kg in non-NUSD group, respectively. The mean age at surgery was 5 ± 7 and 5 ± 3 days, respectively. No malposition was seen in NUSD group, while 57% of UVCs (28% of lines) were malpositioned postoperatively in non-NUSD group (p = 0.048). CONCLUSION: NUSD is an umbilical catheter securement device with low malposition rate, specifically during perioperative period with heightened risk for dislodgement. KEY POINTS: · Umbilical catheters provide reliable access for neonates but have a high rate of malpositioning.. · NUSD is an umbilical catheter securement device with low malposition rate.. · NUSD can be kept in place during laparotomy and can decrease the risk of malpositioning..

Neonatal Healthcare Professionals' Experiences When Implementing a Simulation and Debriefing Program in Neonatal Intensive Care Settings: A Qualitative Analysis.

BACKGROUND: Simulation-based training (SBT) and debriefing have increased in healthcare as a method to conduct interprofessional team training in a realistic environment. PURPOSE: This qualitative study aimed to describe the experiences of neonatal healthcare professionals when implementing a patient safety simulation and debriefing program in a neonatal intensive care unit (NICU). METHODS: Fourteen NICUs in California and Oregon participated in a 15-month quality improvement collaborative with the California Perinatal Quality Care Collaborative. Participating sites completed 3 months of preimplementation work, followed by 12 months of active implementation of the simulation and debriefing program. Focus group interviews were conducted with each site 2 times during the collaborative. Content analysis found emerging implementation themes. RESULTS: There were 234 participants in the 2 focus group interviews. Six implementation themes emerged: (1) receptive context; (2) leadership support; (3) culture change; (4) simulation scenarios; (5) debriefing methodology; and (6) sustainability. Primary barriers and facilitators with implementation of SBT centered around having a receptive context at the unit level (eg, availability of resources and time) and multidisciplinary leadership support. IMPLICATIONS FOR PRACTICE AND RESEARCH: NICUs have varying environmental (context) factors and consideration of unit-level context factors and support from leadership are integral aspects of enhancing the successful implementation of a simulation and debriefing program for neonatal resuscitation. Additional research regarding implementation methods for overcoming barriers for both leaders and participants, as well as determining the optimal frequency of SBT for clinicians, is needed. A knowledge gap remains regarding improvements in patient outcomes with SBT.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

OBJECTIVE: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation. STUDY DESIGN: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone. For other emergency use drugs, prefilled medication syringes have decreased error and administration time. Twenty-one neonatal intensive care unit nurses were enrolled. Each subject engaged in four simulated neonatal resuscitation scenarios involving term or preterm manikins using conventional epinephrine or novel prefilled epinephrine syringes specified for patient weight and administration route. All scenarios were video-recorded. Two investigators analyzed video recordings for time to epinephrine preparation and administration. Differences between conventional and novel techniques were evaluated using the Wilcoxon Signed Rank Tests. RESULTS: Twenty-one subjects completed 42 scenarios with conventional epinephrine and 42 scenarios with novel prefilled syringes. Epinephrine preparation was faster using novel prefilled epinephrine syringes (median = 17.0 s, interquartile range [IQR] = 13.3-22.8) compared with conventional epinephrine (median = 48.0 s, IQR = 40.5-54.9, n = 42, z = 5.64, p < 0.001). Epinephrine administration was also faster using novel prefilled epinephrine syringes (median = 26.9 s, IQR = 22.1-33.2) compared with conventional epinephrine (median = 57.6 s, IQR = 48.8-66.8, n = 42, z = 5.63, p < 0.001). In a poststudy survey, all subjects supported the clinical adoption of prefilled epinephrine syringes. CONCLUSION: During simulated neonatal resuscitation, epinephrine preparation and administration are faster using novel prefilled epinephrine syringes, which may hasten return of spontaneous circulation and be lifesaving for bradycardic neonates in clinical practice. KEY POINTS: · Currently, epinephrine administration in neonatal resuscitation is inefficient and error prone.. · Prefilled epinephrine syringes hasten medication administration in simulated neonatal resuscitation.. · Clinical use of prefilled epinephrine syringes may be lifesaving for bradycardic neonates..

The Debriefing Assessment in Real Time (DART) tool for simulation-based medical education.

BACKGROUND: Debriefing is crucial for enhancing learning following healthcare simulation. Various validated tools have been shown to have contextual value for assessing debriefers. The Debriefing Assessment in Real Time (DART) tool may offer an alternative or additional assessment of conversational dynamics during debriefings. METHODS: This is a multi-method international study investigating reliability and validity. Enrolled raters (n = 12) were active simulation educators. Following tool training, the raters were asked to score a mixed sample of debriefings. Descriptive statistics are recorded, with coefficient of variation (CV%) and Cronbach's α used to estimate reliability. Raters returned a detailed reflective survey following their contribution. Kane's framework was used to construct validity arguments. RESULTS: The 8 debriefings (µ = 15.4 min (SD 2.7)) included 45 interdisciplinary learners at various levels of training. Reliability (mean CV%) for key components was as follows: instructor questions µ = 14.7%, instructor statements µ = 34.1%, and trainee responses µ = 29.0%. Cronbach α ranged from 0.852 to 0.978 across the debriefings. Post-experience responses suggested that DARTs can highlight suboptimal practices including unqualified lecturing by debriefers. CONCLUSION: The DART demonstrated acceptable reliability and may have a limited role in assessment of healthcare simulation debriefing. Inherent complexity and emergent properties of debriefing practice should be accounted for when using this tool.

Data-driven longitudinal characterization of neonatal health and morbidity.

Although prematurity is the single largest cause of death in children under 5 years of age, the current definition of prematurity, based on gestational age, lacks the precision needed for guiding care decisions. Here, we propose a longitudinal risk assessment for adverse neonatal outcomes in newborns based on a deep learning model that uses electronic health records (EHRs) to predict a wide range of outcomes over a period starting shortly before conception and ending months after birth. By linking the EHRs of the Lucile Packard Children's Hospital and the Stanford Healthcare Adult Hospital, we developed a cohort of 22,104 mother-newborn dyads delivered between 2014 and 2018. Maternal and newborn EHRs were extracted and used to train a multi-input multitask deep learning model, featuring a long short-term memory neural network, to predict 24 different neonatal outcomes. An additional cohort of 10,250 mother-newborn dyads delivered at the same Stanford Hospitals from 2019 to September 2020 was used to validate the model. Areas under the receiver operating characteristic curve at delivery exceeded 0.9 for 10 of the 24 neonatal outcomes considered and were between 0.8 and 0.9 for 7 additional outcomes. Moreover, comprehensive association analysis identified multiple known associations between various maternal and neonatal features and specific neonatal outcomes. This study used linked EHRs from more than 30,000 mother-newborn dyads and would serve as a resource for the investigation and prediction of neonatal outcomes. An interactive website is available for independent investigators to leverage this unique dataset: https://maternal-child-health-associations.shinyapps.io/shiny_app/.

Respiratory function monitoring during neonatal resuscitation: A systematic review.

Aim: Positive pressure ventilation via a facemask is critical in neonatal resuscitation, but frequently results in mask leak, obstruction, and inadequate respiratory support. This systematic review aimed to determine whether the display of respiratory function monitoring improved resuscitation or clinical outcomes. Methods: Randomized controlled trials comparing outcomes when respiratory function monitoring was displayed versus not displayed for newborns requiring positive pressure ventilation at birth were selected and from databases (last search August 2022), and assessed for risk of bias using Cochrane Risk of Bias Tools for randomized control trials. The study was registered in the Prospective Register of Systematic Reviews. Grading of Recommendations, Assessment, Development and Evaluations was used to assess the certainty of evidence. Treatment recommendations were approved by the Neonatal Life Support Task Force of the International Liaison Committee on Resuscitation. Results reported primary and secondary outcomes and included resuscitation and clinical outcomes. Results: Of 2294 unique articles assessed for eligibility, three randomized controlled trials were included (observational studies excluded) (n = 443 patients). For predefined resuscitation and clinical outcomes, these studies either did not report the primary outcome (time to heart rate ≥ 100 bpm from birth), had differing reporting methods (achieving desired tidal volumes, significant mask leak) or did not find significant differences (intubation rate, air leaks, death before hospital discharge, severe intraventricular hemorrhage, chronic lung disease). Limitations included limited sample size for critical outcomes, inconsistent definitions amongst studies and unreported long-term outcomes. Conclusion: Although respiratory function monitoring has been utilized in clinical care, there is currently insufficient evidence to suggest its benefit for newborn infants receiving respiratory support for resuscitation at birth. Registration: PROSPERO CRD42021278169 (registered November 27, 2021). Funding: The International Liaison Committee on Resuscitation provided support that included access to software platforms and teleconferencing.

Pilot study of the DART tool - an objective healthcare simulation debriefing assessment instrument.

BACKGROUND: Various rating tools aim to assess simulation debriefing quality, but their use may be limited by complexity and subjectivity. The Debriefing Assessment in Real Time (DART) tool represents an alternative debriefing aid that uses quantitative measures to estimate quality and requires minimal training to use. The DART is uses a cumulative tally of instructor questions (IQ), instructor statements (IS) and trainee responses (TR). Ratios for IQ:IS and TR:[IQ + IS] may estimate the level of debriefer inclusivity and participant engagement. METHODS: Experienced faculty from four geographically disparate university-affiliated simulation centers rated video-based debriefings and a transcript using the DART. The primary endpoint was an assessment of the estimated reliability of the tool. The small sample size confined analysis to descriptive statistics and coefficient of variations (CV%) as an estimate of reliability. RESULTS: Ratings for Video A (n = 7), Video B (n = 6), and Transcript A (n = 6) demonstrated mean CV% for IQ (27.8%), IS (39.5%), TR (34.8%), IQ:IS (40.8%), and TR:[IQ + IS] (28.0%). Higher CV% observed in IS and TR may be attributable to rater characterizations of longer contributions as either lumped or split. Lower variances in IQ and TR:[IQ + IS] suggest overall consistency regardless of scores being lumped or split. CONCLUSION: The DART tool appears to be reliable for the recording of data which may be useful for informing feedback to debriefers. Future studies should assess reliability in a wider pool of debriefings and examine potential uses in faculty development.

The Value of Surgical Data-Impact on the Future of the Surgical Field.

The combination of computing power, connectivity, and big data has been touted as the future of innovation in many fields, including medicine. There has been a groundswell of companies developing tools for improving patient care utilizing healthcare data, but procedural specialties, like surgery, have lagged behind in benefitting from data-based innovations, given the lack of data that is well structured. While many companies are attempting to innovate in the surgical field, some have encountered difficulties around collecting surgical data, given its complex nature. As there is no standardized way in which to interact with healthcare systems to purchase these data, the authors attempt to characterize the various ways in which surgical data are collected and shared. By surveying and conducting interviews with various surgical technology companies, at least 3 different methods to collect surgical data were identified. From this information, the authors conclude that an attempt to outline best practices should be undertaken that benefits all stakeholders.

Turning Practicing Surgeons Into Health Technology Innovators: Outcomes From the Stanford Biodesign Faculty Fellowship.

Background. The Stanford Biodesign Faculty Fellows program was established in 2014 to train Stanford Medical and Engineering faculty in a repeatable innovation process for health technology translation while also being compatible with the busy clinical schedules of surgical faculty members. Methods. Since 2014, 62 faculty members have completed the fellowship with 42% (n = 26) coming from 14 surgical subspecialties. This eight-month, needs-based innovation program covers topics from identifying unmet health-related needs, to inventing new technology, developing plans for intellectual property (IP), regulatory, reimbursement, and business models to advance the technologies toward patient care. Results/Conclusion. Intake and exit survey results from three years of program participants (n = 36) indicate that the fellowship is a valuable hands-on educational program capable of improving awareness and experience with skill sets required for health technology innovation and entrepreneurship.

Lessons Learned from a Collaborative to Develop a Sustainable Simulation-Based Training Program in Neonatal Resuscitation: Simulating Success.

Newborn resuscitation requires a multidisciplinary team effort to deliver safe, effective and efficient care. California Perinatal Quality Care Collaborative's Simulating Success program was designed to help hospitals implement on-site simulation-based neonatal resuscitation training programs. Partnering with the Center for Advanced Pediatric and Perinatal Education at Stanford, Simulating Success engaged hospitals over a 15 month period, including three months of preparatory training and 12 months of implementation. The experience of the first cohort (Children's Hospital of Orange County (CHOC), Sharp Mary Birch Hospital for Women and Newborns (SMB) and Valley Children's Hospital (VCH)), with their site-specific needs and aims, showed that a multidisciplinary approach with a sound understanding of simulation methodology can lead to a dynamic simulation program. All sites increased staff participation. CHOC reduced latent safety threats measured during team exercises from 4.5 to two per simulation while improving debriefing skills. SMB achieved 100% staff participation by identifying unit-specific hurdles within in situ simulation. VCH improved staff confidence level in responding to neonatal codes and proved feasibility of expanding simulation across their hospital system. A multidisciplinary approach to quality improvement in neonatal resuscitation fosters engagement, enables focus on patient safety rather than individual performance, and leads to identification of system issues.

Novel Neonatal Umbilical Catheter Protection and Stabilization Device in In vitro Model of Catheterized Human Umbilical Cords: Effect of Material and Venting on Bacterial Colonization.

OBJECTIVE: Umbilical central lines deliver life-saving medications and nutrition for neonates; however, complications associated with umbilical catheters (UCs) occur more frequently than in adults with central lines (i.e., line migration, systemic infection). We have developed a device for neonatal UC protection and stabilization to reduce catheter exposure to bacteria compared with the standard of care: "goal post" tape configuration. This study analyzes the effect of device venting and material on bacterial load of human umbilical cords in vitro. STUDY DESIGN: Catheters were inserted into human umbilical cord segments in vitro, secured with plastic or silicone vented prototype versus tape, and levels of bacterial colonization were compared between groups after 7 days of incubation. RESULTS: Nonvented plastic prototype showed increased bacterial load compared with goal post (p = 0.04). Colonization was comparable between the goal post and all vented plastic prototypes (p ≥ 0.30) and when compared with the vented silicone device (p = 1). CONCLUSION: A novel silicone device does not increase external bacterial colonization compared with the current standard of care for line securement, and may provide a safe, convenient alternative to standard adhesive tape for UC stabilization. Future studies are anticipated to establish safety in vivo, alongside benefits such as migration and infection reduction.

A Neonatal Intensive Care Unit's Experience with Implementing an In-Situ Simulation and Debriefing Patient Safety Program in the Setting of a Quality Improvement Collaborative.

Extensive neonatal resuscitation is a high acuity, low-frequency event accounting for approximately 1% of births. Neonatal resuscitation requires an interprofessional healthcare team to communicate and carry out tasks efficiently and effectively in a high adrenaline state. Implementing a neonatal patient safety simulation and debriefing program can help teams improve the behavioral, cognitive, and technical skills necessary to reduce morbidity and mortality. In Simulating Success, a 15-month quality improvement (QI) project, the Center for Advanced Pediatric and Perinatal Education (CAPE) and California Perinatal Quality Care Collaborative (CPQCC) provided outreach and training on neonatal simulation and debriefing fundamentals to individual teams, including community hospital settings, and assisted in implementing a sustainable program at each site. The primary Aim was to conduct two simulations a month, with a goal of 80% neonatal intensive care unit (NICU) staff participation in two simulations during the implementation phase. While the primary Aim was not achieved, in-situ simulations led to the identification of latent safety threats and improvement in system processes. This paper describes one unit's QI collaborative experience implementing an in-situ neonatal simulation and debriefing program.

Developing safe devices for neonatal care.

Currently, the majority of medical devices are designed for adults; some are then miniaturized for use in neonates. This process neglects population-specific testing that would ensure that the medical devices used for neonates are actually safe and effective for that group. Incorporating human-centered design principles and utilizing methods to evaluate devices that include simulation and clinical testing can improve the safety of devices used in caring for neonates. However, significant regulatory, financial, social and ethical barriers to development remain. In order to overcome these barriers and create a pipeline of safe and effective neonatal medical devices, specific incentives are required.

Ergonomic Challenges Inherent in Neonatal Resuscitation.

Neonatal resuscitation demands that healthcare professionals perform cognitive and technical tasks while working under time pressure as a team in order to provide efficient and effective care. Neonatal resuscitation teams simultaneously process and act upon multiple data streams, perform ergonomically challenging technical procedures, and coordinate their actions within a small physical space. An understanding and application of human factors and ergonomics science broadens the areas of need in resuscitation research, and will lead to enhanced technologies, systems, and work environments that support human limitations and maximize human performance during neonatal resuscitation.

Simulation-Based Patient-Specific Multidisciplinary Team Training in Preparation for the Resuscitation and Stabilization of Conjoined Twins.

The resuscitation of conjoined twins is a rare and complex clinical challenge. We detail how patient-specific, in situ simulation can be used to prepare a large, multidisciplinary team of health care professionals (HCPs) to deliver safe, efficient, and effective care to such patients. In this case, in situ simulation allowed an 18-person team to address the clinical and ergonomic challenges anticipated for this neonatal resuscitation. The HCPs trained together as an intact team in the actual delivery room environment to probe for human and system weaknesses prior to this unique delivery, and optimized communication, teamwork, and other behavioral skills as they prepared for the simultaneous resuscitation of two patients who were physically joined to one another.

Impact of Standardized Communication Techniques on Errors during Simulated Neonatal Resuscitation.

AIM: Current patterns of communication in high-risk clinical situations, such as resuscitation, are imprecise and prone to error. We hypothesized that the use of standardized communication techniques would decrease the errors committed by resuscitation teams during neonatal resuscitation. METHODS: In a prospective, single-blinded, matched pairs design with block randomization, 13 subjects performed as a lead resuscitator in two simulated complex neonatal resuscitations. Two nurses assisted each subject during the simulated resuscitation scenarios. In one scenario, the nurses used nonstandard communication; in the other, they used standardized communication techniques. The performance of the subjects was scored to determine errors committed (defined relative to the Neonatal Resuscitation Program algorithm), time to initiation of positive pressure ventilation (PPV), and time to initiation of chest compressions (CC). RESULTS: In scenarios in which subjects were exposed to standardized communication techniques, there was a trend toward decreased error rate, time to initiation of PPV, and time to initiation of CC. While not statistically significant, there was a 1.7-second improvement in time to initiation of PPV and a 7.9-second improvement in time to initiation of CC. CONCLUSIONS: Should these improvements in human performance be replicated in the care of real newborn infants, they could improve patient outcomes and enhance patient safety.

Modification of the Neonatal Resuscitation Program Algorithm for Resuscitation of Conjoined Twins.

There are no national or international guidelines for the resuscitation of conjoined twins. We have described how the U.S. Neonatal Resuscitation Program algorithm can be modified for delivery room resuscitation of omphaloischiopagus conjoined twins. In planning for the delivery and resuscitation of these patients, we considered the challenges of providing cardiopulmonary support to preterm conjoined twins in face-to-face orientation and with shared circulation via a fused liver and single umbilical cord. We also demonstrate how in situ simulation can be used to prepare a large, multidisciplinary team of health care professionals to deliver safe, efficient, and effective care to such patients.