Delivery Room Resuscitation of Infants with Congenital Diaphragmatic Hernia: Lessons Learned through Video Review.

INTRODUCTION: Delivery room (DR) interventions for infants with congenital diaphragmatic hernia (CDH) are not well described. This study sought to describe timing and order of DR interventions and identify system factors impacting CDH DR resuscitations using a human factors framework. METHODS: Single center observational study of video recorded CDH DR resuscitations documenting timing and order of interventions. The team used the Systems Engineering Initiative for Patient Safety (SEIPS) model to identify system factors impacting DR resuscitations and time to invasive ventilation. RESULTS: We analyzed 31 video recorded CDH resuscitations. We observed variability in timing and order of resuscitation tasks. The 'Internal Environment' and 'Tasks' components of the SEIPS model were prominent factors affecting resuscitation efficiency; significant room and bed spatial constraints exist, and nurses have a significant task burden. Additionally, endotracheal tube preparation was a prominent barrier to timely invasive ventilation. CONCLUSION: Video review revealed variation in event timing and order during CDH resuscitations. Standardization of room set-up, equipment, and event order and reallocation of tasks facilitate more efficient intubation and ventilation, representing targets for CDH DR improvement initiatives. This work emphasizes the utility of rigorous human factors review to identify areas for improvement during DR resuscitation.

Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals.

BACKGROUND/AIMS: Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation. METHODS: We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively. RESULTS: Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively; P = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3), P < 0.001. CONCLUSION: Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.

Outcomes after delivery room positive pressure ventilation in late preterm and term infants.

Objectives: Characterize short-term outcomes of late preterm and term infants who received positive pressure ventilation in the delivery room and compare these with infants who did not receive resuscitation at birth. Study Design: Single center retrospective cohort study of infants born between 35 0/7 and 41 6/7 weeks' gestation in 2019. Baseline characteristics and outcomes of infants who received positive pressure ventilation were compared with controls who did not receive delivery room ventilation. The primary outcome was neonatal intensive care unit admission; secondary outcomes included multiple hospital morbidities and interventions. Results: Among 202 infants who received delivery room positive pressure ventilation, 77 (38.1%) received ≤1 min, and 125 (61.9%) received >1 min of positive pressure ventilation. Neonatal intensive care unit admission directly following resuscitation was more common in the ventilation cohort (33%) compared with controls (1.5%), p ≤ 0.0001. After initial admission to the newborn nursery, intensive care unit transfer rates were similar in the positive pressure ventilation cohort (4%) and controls (5%). Antibiotic exposure, hypoxic ischemic encephalopathy, respiratory support in the neonatal intensive care unit, and pneumothorax were more common in the ventilation cohort. The composite outcome of any post-delivery complication occurred in 45% of positive pressure ventilation-exposed infants, compared to 15.8% of control infants (<0.0001); this was more common following >1 min (52.8%) than ≤1 min positive pressure ventilation (32.5%), p = 0.002. Conclusion: Post-delivery complications are common following delivery room positive pressure ventilation, emphasizing the need for post-resuscitation monitoring in either the neonatal intensive care unitor newborn nursery setting.

Laryngeal mask use during neonatal resuscitation at birth: A United States-based survey of neonatal resuscitation program providers and instructors.

Aim: Neonatal resuscitation guidelines promote the laryngeal mask (LM) interface for positive pressure ventilation (PPV), but little is known about how the LM is used among Neonatal Resuscitation Program (NRP) Providers and Instructors. The study aim was to characterize the training, experience, confidence, and perspectives of NRP Providers and Instructors regarding LM use during neonatal resuscitation at birth. Methods: A voluntary anonymous survey was emailed to all NRP Providers and Instructors. Survey items addressed training, experience, confidence, and barriers for LM use during resuscitation. Associations between respondent characteristics and outcomes of both LM experience and confidence were assessed using logistic regression. Results: Between 11/7/22-12/12/22, there were 5,809 survey respondents: 68% were NRP Providers, 55% were nurses, and 87% worked in a hospital setting. Of these, 12% had ever placed a LM during newborn resuscitation, and 25% felt very or completely confident using a LM. In logistic regression, clinical or simulated hands-on training, NRP Instructor role, professional role, and practice setting were all associated with both LM experience and confidence.The three most frequently identified barriers to LM use were insufficient experience (46%), preference for other interfaces (25%), and failure to consider the LM during resuscitation (21%). One-third (33%) reported that LMs are not available where they resuscitate newborns. Conclusion: Few NRP providers and instructors use the LM during neonatal resuscitation. Strategies to increase LM use include hands-on clinical training, outreach promoting the advantages of the LM compared to other interfaces, and improving availability of the LM in delivery settings.

Endotracheal Tube Size Adjustments Within Seven Days of Neonatal Intubation.

BACKGROUND AND OBJECTIVES: Neonatal endotracheal tube (ETT) size recommendations are based on limited evidence. We sought to determine data-driven weight-based ETT sizes for infants undergoing tracheal intubation and to compare these with Neonatal Resuscitation Program (NRP) recommendations. METHODS: Retrospective multicenter cohort study from an international airway registry. We evaluated ETT size changes (downsizing to a smaller ETT during the procedure or upsizing to a larger ETT within 7 days) and risk of procedural adverse outcomes associated with first-attempt ETT size selection when stratifying the cohort into 200 g subgroups. RESULTS: Of 7293 intubations assessed, the initial ETT was downsized in 5.0% of encounters and upsized within 7 days in 1.5%. ETT downsizing was most common when NRP-recommended sizes were attempted in the following weight subgroups: 1000 to 1199 g with a 3.0 mm (12.6%) and 2000 to 2199 g with a 3.5 mm (17.1%). For infants in these 2 weight subgroups, selection of ETTs 0.5 mm smaller than NRP recommendations was independently associated with lower odds of adverse outcomes compared with NRP-recommended sizes. Among infants weighing 1000 to 1199 g: any tracheal intubation associated event, 20.8% with 2.5 mm versus 21.9% with 3.0 mm (adjusted OR [aOR] 0.62, 95% confidence interval [CI] 0.41-0.94); severe oxygen desaturation, 35.2% with 2.5 mm vs 52.9% with 3.0 mm (aOR 0.53, 95% CI 0.38-0.75). Among infants weighing 2000 to 2199 g: severe oxygen desaturation, 41% with 3.0 mm versus 56% with 3.5mm (aOR 0.55, 95% CI 0.34-0.89). CONCLUSIONS: For infants weighing 1000 to 1199 g and 2000 to 2199 g, the recommended ETT size was frequently downsized during the procedure, whereas 0.5 mm smaller ETT sizes were associated with fewer adverse events and were rarely upsized.

Factors that impact second attempt success for neonatal intubation following first attempt failure: a report from the National Emergency Airway Registry for Neonates.

OBJECTIVE: To determine the factors associated with second attempt success and the risk of adverse events following a failed first attempt at neonatal tracheal intubation. DESIGN: Retrospective analysis of prospectively collected data on intubations performed in the neonatal intensive care unit (NICU) and delivery room from the National Emergency Airway Registry for Neonates (NEAR4NEOS). SETTING: Eighteen academic NICUs in NEAR4NEOS. PATIENTS: Neonates requiring two or more attempts at intubation between October 2014 and December 2021. MAIN OUTCOME MEASURES: The primary outcome was successful intubation on the second attempt, with severe tracheal intubation-associated events (TIAEs) or severe desaturation (≥20% decline in oxygen saturation) being secondary outcomes. Multivariate regression examined the associations between these outcomes and patient characteristics and changes in intubation practice. RESULTS: 5805 of 13 126 (44%) encounters required two or more intubation attempts, with 3156 (54%) successful on the second attempt. Second attempt success was more likely with changes in any of the following: intubator (OR 1.80, 95% CI 1.56 to 2.07), stylet use (OR 1.65, 95% CI 1.36 to 2.01) or endotracheal tube (ETT) size (OR 2.11, 95% CI 1.74 to 2.56). Changes in stylet use were associated with a reduced chance of severe desaturation (OR 0.74, 95% CI 0.61 to 0.90), but changes in intubator, laryngoscope type or ETT size were not; no changes in intubator or equipment were associated with severe TIAEs. CONCLUSIONS: Successful neonatal intubation on a second attempt was more likely with a change in intubator, stylet use or ETT size.

Success rates and adverse events during neonatal intubation: Lessons learned from an international registry.

Neonatal endotracheal intubation is a challenging procedure with suboptimal success and adverse event rates. Systematically tracking intubation outcomes is imperative to understand both universal and site-specific barriers to intubation success and safety. The National Emergency Airway Registry for Neonates (NEAR4NEOS) is an international registry designed to improve neonatal intubation practice and outcomes that includes over 17,000 intubations across 23 international sites as of 2023. Methods to improve intubation safety and success include appropriately matching the intubation provider and situation and increasing adoption of evidence-based practices such as muscle relaxant premedication and video laryngoscope, and potentially new interventions such as procedural oxygenation.

Providing Oxygen during Intubation in the NICU Trial (POINT): study protocol for a randomised controlled trial in the neonatal intensive care unit in the USA.

INTRODUCTION: Nearly half of neonatal intubations are complicated by severe desaturation (≥20% decline in pulse oximetry saturation (SpO2)). Apnoeic oxygenation prevents or delays desaturation during intubation in adults and older children. Emerging data show mixed results for apnoeic oxygenation using high-flow nasal cannula (NC) during neonatal intubation. The study objective is to determine among infants ≥28 weeks' corrected gestational age (cGA) who undergo intubation in the neonatal intensive care unit (NICU) whether apnoeic oxygenation with a regular low-flow NC, compared with standard of care (no additional respiratory support), reduces the magnitude of SpO2 decline during intubation. METHODS AND ANALYSIS: This is a multicentre, prospective, unblinded, pilot randomised controlled trial in infants ≥28 weeks' cGA who undergo premedicated (including paralytic) intubation in the NICU. The trial will recruit 120 infants, 10 in the run-in phase and 110 in the randomisation phase, at two tertiary care hospitals. Parental consent will be obtained for eligible patients prior to intubation. Patients will be randomised to 6 L NC 100% oxygen versus standard of care (no respiratory support) at time of intubation. The primary outcome is magnitude of oxygen desaturation during intubation. Secondary outcomes include additional efficacy, safety and feasibility outcomes. Ascertainment of the primary outcome is performed blinded to intervention arm. Intention-to-treat analyses will be conducted to compare outcomes between treatment arms. Two planned subgroup analyses will explore the influence of first provider intubation competence and patients' baseline lung disease using pre-intubation respiratory support as a proxy. ETHICS AND DISSEMINATION: The Institutional Review Boards at the Children's Hospital of Philadelphia and the University of Pennsylvania have approved the study. Upon completion of the trial, we intend to submit our primary results to a peer review forum after which we plan to publish our results in a peer-reviewed paediatric journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05451953).

Decreasing Intubation for Ineffective Ventilation after Birth for Very Low Birth Weight Neonates.

Despite recommendations promoting noninvasive delivery room (DR) ventilation, local historical preterm DR noninvasive ventilation rates were low (50%-64%). Project aims were to improve DR noninvasive ventilation rate in very low birth weight (VLBW) neonates (<1500 g) with a focus on decreasing DR intubations for ineffective positive pressure ventilation (PPV). Methods: We addressed drivers for improving noninvasive ventilation and decreasing intubations for ineffective PPV through plan-do-study-act cycles. Outcome measures were intubation for ineffective PPV (defined as intubation for heart rate <100 despite ongoing PPV) and final respiratory support in the DR. Our process measure was adherence to division-wide DR-intubation guidelines. Balancing measures were maximum FiO2 and hypothermia. We analyzed data using statistical process control charts and special cause variation rules. Results: There were 139 DR intubations among 521 VLBW neonates between January 2015 and February 2020. The noninvasive ventilation rate upon intensive care nursery admission was higher than historically reported at 73% and sustained throughout the project. The intubation rate for ineffective PPV was 10% and did not change. The number of VLBW neonates between intubations for ineffective PPV increased from 6.1 to 8.0. Ten intubations did not comply with guidelines. Balancing measures were unaffected. Conclusions: Noninvasive ventilation rates were higher than historically reported and remained high. After plan-do-study-act cycles, the number of VLBW neonates between intubations for ineffective PPV increased without impacting balancing measures. Our data demonstrate that effective ventilation (heart rate > 100) using noninvasive support is possible in up to 90% of VLBW infants but requires ongoing PPV training.

Impact of multiple intubation attempts on adverse tracheal intubation associated events in neonates: a report from the NEAR4NEOS.

OBJECTIVE: To determine the relationship between number of attempts and adverse events during neonatal intubation. STUDY DESIGN: A retrospective study of prospectively collected data of intubations in the delivery room and NICU from the National Emergency Airway Registry for Neonates (NEAR4NEOS) in 17 academic centers from 1/2016 to 12/2019. We examined the association between tracheal intubation attempts [1, 2, and ≥3 (multiple attempts)] and clinical adverse outcomes (any tracheal intubation associated events (TIAE), severe TIAE, and severe oxygen desaturation). RESULTS: Of 7708 intubations, 1474 (22%) required ≥3 attempts. Patient, provider, and practice factors were associated with higher TI attempts. Increasing intubation attempts was independently associated with a higher risk for TIAE. The adjusted odds ratio for TIAE and severe oxygen desaturation were significantly higher in TIs with 2 and ≥3 attempts than with one attempt. CONCLUSION: The risk of adverse safety events during intubation increases with the number of intubation attempts.

Post-cardiac arrest physiology and management in the neonatal intensive care unit.

AIM: The importance of high-quality post-cardiac arrest care is well-described in adult and paediatric populations, but data are lacking to inform post-cardiac arrest care in the neonatal intensive care unit (NICU). The objective of this study was to describe post-cardiac arrest physiology and management in a quaternary NICU. METHODS: Retrospective descriptive study of post-cardiac arrest physiology and management. Data were abstracted from electronic medical records and an institutional resuscitation database. A cardiac arrest was defined as ≥1 minute of chest compressions. Only index arrests were analysed. Descriptive statistics were used to report patient, intra-arrest, and post-arrest characteristics. RESULTS: There were 110 index cardiac arrests during the 5-year study period from 1/2017-2/2021. The majority (69%) were acute respiratory compromise leading to cardiopulmonary arrest (ARC-CPA) and 26% were primary cardiopulmonary arrests (CPA). Vital sign monitoring within 24 hours post-arrest was variable, especially non-invasive blood pressure frequency (median 5, range 1-44 measurements). There was a high prevalence of hypothermia (73% of arrest survivors). There was substantial variability in laboratory frequency within 24 hours post-arrest. Patients with primary CPA received significantly more lab testing and had a higher prevalence of acidosis (pH < 7.2) than those with ARC-CPA. CONCLUSIONS: We identified significant variation in post-arrest management and a high prevalence of hypothermia. These data highlight the need for post-arrest management guidelines specific to neonatal physiology, as well as opportunities for quality improvement initiatives. Further research is needed to ascertain the impact of neonatal post-arrest management on long-term outcomes and survival.

Reducing Severe Tracheal Intubation Events Through an Individualized Airway Bundle.

BACKGROUND: Neonatal tracheal intubation (TI) is a high-risk procedure associated with adverse safety events. In our newborn and infant ICU, we measure adverse tracheal intubation-associated events (TIAEs) as part of our participation in National Emergency Airway Registry for Neonates, a neonatal airway registry. We aimed to decrease overall TIAEs by 10% in 12 months. METHODS: A quality improvement team developed an individualized approach to intubation using an Airway Bundle (AB) for patients at risk for TI. Plan-do-study-act cycles included AB creation, simulation, unit roll out, interprofessional education, team competitions, and adjusting AB location. Outcome measure was monthly rate of TIAEs (overall and severe). Process measures were AB initiation, AB use at intubation, video laryngoscope (VL) use, and paralytic use. Balancing measure was inadvertent administration of TI premedication. We used statistical process control charts. RESULTS: Data collection from November 2016 to August 2020 included 1182 intubations. Monthly intubations ranged from 12 to 41. Initial overall TIAE rate was 0.093 per intubation encounter, increased to 0.172, and then decreased to 0.089. System stability improved over time. Severe TIAE rate decreased from 0.047 to 0.016 in June 2019. AB initiation improved from 70% to 90%, and AB use at intubation improved from 18% to 55%. VL use improved from 86% to 97%. Paralytic use was 83% and did not change. The balancing measure of inadvertent TI medication administration occurred once. CONCLUSIONS: We demonstrated a significant decrease in the rate of severe TIAEs through the implementation of an AB. Next steps include increasing use of AB at intubation.

Birth Volume and Geographic Distribution of US Hospitals With Obstetric Services From 2010 to 2018.

Importance: Timely access to clinically appropriate obstetric services is critical to the provision of high-quality perinatal care. Objective: To examine the geographic distribution, proximity, and urban adjacency of US obstetric hospitals by annual birth volume. Design, Setting, and Participants: This retrospective population-based cohort study identified US hospitals with obstetric services using the American Hospital Association (AHA) Annual Survey of Hospitals and Centers for Medicare & Medicaid provider of services data from 2010 to 2018. Obstetric hospitals with 10 or more births per year were included in the study. Data analysis was performed from November 6, 2020, to April 5, 2021. Exposure: Hospital birth volume, defined by annual birth volume categories of 10 to 500, 501 to 1000, 1001 to 2000, and more than 2000 births. Main Outcomes and Measures: Outcomes assessed by birth volume category were percentage of births (from annual AHA data), number of hospitals, geographic distribution of hospitals among states, proximity between obstetric hospitals, and urban adjacency defined by urban influence codes, which classify counties by population size and adjacency to a metropolitan area. Results: The study included 26 900 hospital-years of data from 3207 distinct US hospitals with obstetric services, reflecting 34 054 951 associated births. Most infants (19 327 487 [56.8%]) were born in hospitals with more than 2000 births/y, and 2 528 259 (7.4%) were born in low-volume (10-500 births/y) hospitals. More than one-third of obstetric hospitals (37.4%; 10 064 hospital-years) were low volume. A total of 46 states had obstetric hospitals in all volume categories. Among low-volume hospitals, 18.9% (1904 hospital-years) were not within 30 miles of any other obstetric hospital and 23.9% (2400 hospital-years) were within 30 miles of a hospital with more than 2000 deliveries/y. Isolated hospitals (those without another obstetric hospital within 30 miles) were more frequently low volume, with 58.4% (1112 hospital-years) located in noncore rural areas. Conclusions and Relevance: In this cohort study, marked variations were found in birth volume, geographic distribution, proximity, and urban adjacency among US obstetric hospitals from 2010 to 2018. The findings related to geographic isolation and rural-urban distribution of low-volume obstetric hospitals suggest the need to balance proximity with volume to optimize effective referral and access to high-quality perinatal care.

Impact of flow disruptions in the delivery room.

AIM: Flow disruptions (FDs) are deviations from the progression of care that compromise safety and efficiency of a specific process. The study aim was to identify the impact of FDs during neonatal resuscitation and determine their association with key process and outcome measures. METHODS: Prospective observational study of video recorded delivery room resuscitations of neonates <32 weeks gestational age. FDs were classified using an adaptation of Wiegmann's FD tool. The primary outcome was target oxygenation saturation achievement at 5 min. Secondary outcomes included achieving target saturation at 10 min, time to positive pressure ventilation for initially apnoeic/bradycardic neonates, time to electrocardiogram signal, time to pulse oximetry signal, and time to stable airway. Multivariable logistic regression assessed association between FDs and achieving target saturations adjusting for gestational age and leader. Associations between FDs and time to event outcomes were assessed using Cox proportional hazards models. RESULTS: Between 10/2017-7/2018, 32 videos were included. A mean of 52.6 FDs (standard deviation 17.9) occurred per resuscitation. Extraneous FDs were the most common FDs. FDs were associated with an adjusted odds ratio of 0.92 (95% confidence interval [CI] 0.80-1.05) of achieving target saturation at 5 min and 0.94 (95% CI 0.84-1.05) at 10 min. There was no significant evidence to show FDs were associated with time to event outcomes. CONCLUSIONS: FDs occurred frequently during neonatal resuscitation. Measuring FDs is a feasible method to assess the impact of human factors in the delivery room and identify modifiable factors and practices to improve patient care.

Visual attention patterns of team leaders during delivery room resuscitation.

AIM: To assess visual attention of neonatal team leaders during delivery room resuscitation of preterm infants using eye tracking glasses. METHODS: Prospective observational eye tracking study. Gaze fixations and sequences were captured, categorized, and mapped during the first 5 min of the resuscitations. Gaze fixation metrics of total gaze duration, visit count, and visit duration were summarized and compared based on interventions performed and provider training level. Fixation sequences were compared between attending neonatologists and fellows. RESULTS: During 18 eye tracking recordings, practitioners focused most of their cumulative visual attention on the infant (median total gaze duration 57%, interquartile range [IQR] 38-61%), followed by monitors (24%, IQR 13-46%), clinical staff (5%, IQR 1-8%), other physical objects (4%, IQR 3-6%), T-piece resuscitator (2%, IQR 0-4%) and the Apgar timer (1%, IQR 0-2%). Visual attention parameters varied according to intervention, with higher visit counts on the infant during corrective ventilation steps than during Continuous Positive Airway Pressure (CPAP) or Positive Pressure Ventilation (PPV), and longer visit durations on monitors during PPV. Time and frequency-based measures of visual attention did not significantly differ by provider training level, but patterned fixation sequences were identified among attending neonatologists that were not observed in fellows. CONCLUSION: Team leaders predominantly gazed upon the infant and monitors during resuscitation, and visual attention parameters varied depending on the respiratory interventions performed. Attending neonatologists exhibited patterned fixation sequences that were not observed in fellows. Study results may have implications for optimizing delivery room design and training novice providers.