Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm.

OBJECTIVE: To evaluate the possible noninferiority of surfactant administration via laryngeal mask airway (LMA) vs endotracheal tube (ETT) in avoiding the requirement for mechanical ventilation in preterm neonates with respiratory distress syndrome (RDS). STUDY DESIGN: This was a randomized controlled trial including infants born at 27 to 36 weeks of gestation, >800 g, diagnosed with RDS and receiving fraction of inspired oxygen 0.30-0.60 via noninvasive respiratory support. Infants were randomized to surfactant via LMA (with atropine premedication) or ETT (InSuRE approach with atropine and remifentanil premedication). Primary outcome was failure of surfactant treatment to prevent the need for mechanical ventilation. RESULTS: Patients were randomized, 51 to LMA and 42 to the ETT group. Both groups had similar baseline characteristics, with birth weights ranging from 810 to 3560 g. Failure rate was 29% in the ETT group and 20% in the LMA group (P = .311). This difference was due to early failures (within 1 hour), with 12.5% in the ETT group and 2% in the LMA group (P = .044). Surfactant therapy via LMA was non-inferior to administration via ETT; failure risk difference -9.0% (CI -∞ to 5.7%). Efficacy in decreasing fraction of inspired oxygen, number of surfactant doses administered, time to wean off all respiratory support, rates of adverse events, and outcomes including pneumothorax and BPD diagnosis did not differ between groups. CONCLUSIONS: Surfactant therapy via LMA was noninferior to administration via ETT and it decreased early failures, possibly by avoiding adverse effects of premedication, laryngoscopy, and intubation. These characteristics make LMA a desirable conduit for surfactant administration. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02164734.

Factors contributing to endobronchial intubation in neonates.

OBJECTIVES: To assess neonatologists' practices, knowledge, and opinions regarding the prevention of endobronchial intubation. DESIGN: Anonymous survey. SUBJECTS AND SETTING: Program Directors of Neonatology Fellowship Programs in the United States, surveyed by mail, and neonatologists who volunteered to respond while attending the Vermont-Oxford Network Annual Meeting. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Program directors (response rate 66%) and other practitioners contributed equally to the 132 survey responses, which were statistically indistinguishable between groups. Deep intubation frequency was estimated at greater than 5% by 39% of respondents, and 38% believed that it contributes to neonatal morbidity equally or more than medication errors. Quality assurance surveillance of intubations was uncommon. Neonatologists had remarkably varied responses when identifying the recommended vocal cord-level marking from a triple set of distal safety markings on a commonly used endotracheal tube; most had never seen recommendations or package insert directions for the use of such markings, and 86% desired improvements in endotracheal tube features to promote safer intubations. CONCLUSIONS: Neonatologists perceive endobronchial intubation as a consequential but underreported complication. Most are uncertain about the use of common vocal cord markings on endotracheal tubes, and few have seen specific instructions on this feature. We suggest that standardizing endotracheal tube safety features and making clear directions available to users may decrease the risk of endobronchial intubation in neonates.

Neonatal Airway Management.

The neonatal airway is often difficult to secure, whether the practitioner responsible for managing the airway is a neonatologist, pediatrician, anesthesiologist, another specialist or an advanced practice provider [...].

A Multifunctional, Low Cost and Sustainable Neonatal Database System.

Continuous improvement in the clinical performance of neonatal intensive care units (NICU) depends on the use of locally relevant, reliable data. However, neonatal databases with these characteristics are typically unavailable in NICUs using paper-based records, while in those using electronic records, the inaccuracy of data and the inability to customize commercial data systems limit their usability for quality improvement or research purposes. We describe the characteristics and uses of a simple, neonatologist-centered data system that has been successfully maintained for 30 years, with minimal resources and serving multiple purposes, including quality improvement, administrative, research support and educational functions. Structurally, our system comprises customized paper and electronic components, while key functional aspects include the attending-based recording of diagnoses, integration into clinical workflows, multilevel data accuracy and validation checks, and periodic reporting on both data quality and NICU performance results. We provide examples of data validation methods and trends observed over three decades, and discuss essential elements for the successful implementation of this system. This database is reliable and easily maintained; it can be developed from simple paper-based forms or used to supplement the functionality and end-user customizability of existing electronic medical records. This system should be readily adaptable to NICUs in either high- or limited-resource environments.

Strategies to Improve Neonatal Intubation Safety by Preventing Endobronchial Placement of the Tracheal Tube-Literature Review and Experience at a Tertiary Center.

Unintended endobronchial placement is a common complication of neonatal tracheal intubation and a threat to patient safety, but it has received little attention towards decreasing its incidence and mitigating associated harms. We report on the key aspects of a long-term project in which we applied principles of patient safety to design and implement safeguards and establish a safety culture, aiming to decrease the rate of deep intubation (beyond T3) in neonates to <10%. Results from 5745 consecutive intubations revealed a 47% incidence of deep tube placement at baseline, which decreased to 10-15% after initial interventions and remained in the 9-20% range for the past 15 years; concurrently, rates of deep intubation at referring institutions have remained high. Root cause analyses revealed multiple contributing factors, so countermeasures specifically aimed at improving intubation safety should be applied before, during, and immediately after tube insertion. Extensive literature review, concordant with our experience, suggests that pre-specifying the expected tube depth before intubation is the most effective and simple intervention, although further research is needed to establish accurate and accepted standards for estimating the expected depth. Presently, team training on intubation safety, plus possible technological advances, offer additional options for safer neonatal intubations.

Leveraging Telemedicine to Spread Expertise in Neonatal Resuscitation.

The development and potential applications of telemedicine in neonatal resuscitation were reviewed by Donohue and colleagues in 2019, in a manuscript that compiled seminal references in the field [...].

Laryngeal Masks in Neonatal Resuscitation-A Narrative Review of Updates 2022.

Positive pressure ventilation (PPV) is crucial to neonatal cardiopulmonary resuscitation because respiratory failure precedes cardiac failure in newborns affected by perinatal asphyxia. Prolonged ineffective PPV could lead to a need for advanced resuscitation such as intubation, chest compression, and epinephrine. Every 30 s delay in initiation of PPV increased the risk of death or morbidity by 16%. The most effective interface for providing PPV in the early phases of resuscitation is still unclear. Laryngeal masks (LMs) are supraglottic airway devices that provide less invasive and relatively stable airway access without the need for laryngoscopy which have been studied as an alternative to face masks and endotracheal tubes in the initial stages of neonatal resuscitation. A meta-analysis found that LM is a safe and more effective alternative to face mask ventilation in neonatal resuscitation. LM is recommended as an alternative secondary airway device for the resuscitation of infants > 34 weeks by the International Liaison Committee on Resuscitation. It is adopted by various national neonatal resuscitation guidelines across the globe. Recent good-quality randomized trials have enhanced our understanding of the utility of laryngeal masks in low-resource settings. Nevertheless, LM is underutilized due to its variable availability in delivery rooms, providers' limited experience, insufficient training, preference for endotracheal tube, and lack of awareness.

Tracheal Length Measurement in Intubated Neonates to Guide the Design and Use of Endotracheal Tube Glottic Depth Markings.

BACKGROUND: Data on neonatal tracheal length are needed to inform the standardization of safety features for endotracheal tubes (ETTs) such as glottic depth markings. Laryngotracheal airway measurements are available from digital imaging in infants and children but not in neonates. We aimed to determine the tracheal length (TL) of intubated preterm and term neonates. METHODS: An observational study was performed on 57 neonates of 22-42 weeks' gestation and <1 week of age. Two clinicians independently reviewed 153 digital chest radiographs to determine the carina position and TL. TL was measured from carina to mid-C4 (cricoid level). We analyzed interrater agreement (within 0.5 vertebral levels) on the position of the carina and TL. TL was plotted as a function of gestational age and weight, using graphical and regression analyses. RESULTS: Carina position ranged from T3 to T5.5, with an interrater agreement of 95%. On image pairs concordant for carina position, TL determinations were virtually identical between readers (mean difference 0.1 mm, 95% CI -0.5-0.6 mm). Average mid-tracheal length overlies the body of T1. In infants aged less than 32 weeks' gestation, the mid-trachea lies <20 mm from the carina or the larynx. TL linearly correlates with gestational age, but correlation with birthweight best fits a segmented regression with a node at 1 kg. CONCLUSIONS: The functional length of the laryngotracheal airway can be reliably measured in sick neonates. It correlates well with gestational age and birthweight, and this information can inform the redesign of ETT markings to promote the safer use of these devices.

The Impact of Maternal Obesity on NICU and Newborn Nursery Costs.

Background: Research on the effects of maternal obesity on neonates has focused on clinical outcomes. Despite growing interest in obesity as a driver of healthcare expenditure, the financial impact of maternal obesity in the neonatal setting is little understood. Objective: To determine if maternal obesity is associated with higher incurred costs in NICU and full-term nursery. Methods: Data for all live births (1/1/14-12/31/19) at our academic medical center was obtained from the New York State Perinatal Data System for infants >23 weeks gestational age. Financial data was obtained from the hospital's cost-processing application. Infants with missing clinical and/or financial data were excluded. The NIH definition of obesity was used (BMI ≥ 30 kg/m2) to separate infants born to obese and non-obese mothers. Student's t-tests and chi square tests were used to compare maternal data, delivery, and infant outcomes between both groups. A logistic regression model was used to compare infant outcomes using odds ratios while controlling for maternal risk factors (smoking status, pre-pregnancy and gestational diabetes, pre-pregnancy and gestational hypertension). Multivariate regression analysis adjusting for maternal risk factors was also used to compare length-of-stay, total and direct costs in the NICU and full-term nursery between infant groups. Results: Of the 11,610 pregnancies in this retrospective study, obese mothers more frequently had other risk factors (smoke, pre-pregnancy and gestational diabetes, and pre-pregnancy and gestational hypertension). Infants born to obese mothers were more often preterm, had Cesarean delivery, lower APGAR scores, required assisted ventilation in the delivery room, and required NICU admission. Adjusting for maternal risk factors, infants born to obese mothers were less frequently preterm (OR 0.82 [0.74-0.91], p < 0.01) and had NICU stays (OR 0.98 [0.81-0.98], p = 0.02), but more frequently had Cesarean births (OR 1.54 [1.42-1.67], p < 0.01). They also had longer adjusted LOS (2.03 ± 1.51 vs. 1.92 ± 1.45 days, p < 0.01) and higher mean costs per infant in the full-term nursery ($3,638.34 ± $6,316.69 vs. $3,375.04 ± $4,994.18, p = 0.03) but not in NICU. Conclusions: Maternal obesity correlates with other risk factors. Prolonged maternal stay may explain increased LOS and costs in the full-term nursery for infants born to obese mothers, as infants wait to be discharged with mothers.

Experiences of a Regional Quality Improvement Collaborative to Reduce Unplanned Extubations in the Neonatal Intensive Care Unit.

BACKGROUND: Unplanned extubations (UEs) occur frequently in the neonatal intensive care unit (NICU). These events can be associated with serious short-term and long-term morbidities and increased healthcare costs. Most quality improvement (QI) initiatives focused on UE prevention have concentrated efforts within individual NICUs. METHODS: We formed a regional QI collaborative involving the four regional perinatal center (RPC) NICUs in upstate New York to reduce UEs. The collaborative promoted shared learning and targeted interventions specific to UE classification at each center. RESULTS: There were 1167 UEs overall during the four-year project. Following implementation of one or more PDSA cycles, the combined UE rate decreased by 32% from 3.7 to 2.5 per 100 ventilator days across the collaborative. A special cause variation was observed for the subtype of UEs involving removed endotracheal tubes (rETTs), but not for dislodged endotracheal tubes (dETTs). The center-specific UE rates varied; only two centers observed significant improvement. CONCLUSIONS: A collaborative approach promoted knowledge sharing and fostered an overall improvement, although the individual centers' successes varied. Frequent communication and shared learning experiences benefited all the participants, but local care practices and varying degrees of QI experience affected each center's ability to successfully implement potentially better practices to prevent UEs.

Wide Variation in Unplanned Extubation Rates Related to Differences in Operational Definitions.

OBJECTIVES: Unplanned extubation (UE) rate is a patient safety metric for which there are varied and inconsistently interpreted definitions. We aimed to test the sensitivity of UE rates to the application of different operational definitions. METHODS: We analyzed neonatal intensive care unit (NICU) quality improvement data on UE events defined inclusively as "any extubation that was not performed electively, or not previously intended for that time." Unplanned extubations were classified as involving an endotracheal tube (ETT) that was either objectively "dislodged" or "removed" without proof of prior dislodgement. We used descriptive statistics to explore how UE rates vary when applying alternate UE definitions. RESULTS: For 33 months, 241 UEs were documented, 70% involving dislodged tubes and 30% ETTs removed by staff. Among dislodged ETTs, only 9% were found completely externalized, whereas 77% were at an adequate depth but in the esophagus. Thirteen percent of events occurred outside the NICU and 13% were initially unreported. The overall UE rate was 4.9/100 ventilator days. If the least inclusive definition was used (i.e., counting only "self-extubations" by patients, requiring reintubation, and occurring within the NICU), 83% of UEs would have been excluded. CONCLUSIONS: Most UEs in our NICU population involved staff either removing ETTs from the trachea or partly removing them after internal dislodgement. In settings where ETTs removed by staff are not counted, UE rates may be substantially lower and associated risks underestimated. An inclusive, patient-centric operational definition along with a standardized classification would allow benchmarking, while enabling targeted approaches to minimize locally predominant causes of UEs.

The mitochondrial connection in auditory neuropathy.

'Auditory neuropathy' (AN), the term used to codify a primary degeneration of the auditory nerve, can be linked directly or indirectly to mitochondrial dysfunction. These observations are based on the expression of AN in known mitochondrial-based neurological diseases (Friedreich's ataxia, Mohr-Tranebjærg syndrome), in conditions where defects in axonal transport, protein trafficking, and fusion processes perturb and/or disrupt mitochondrial dynamics (Charcot-Marie-Tooth disease, autosomal dominant optic atrophy), in a common neonatal condition known to be toxic to mitochondria (hyperbilirubinemia), and where respiratory chain deficiencies produce reductions in oxidative phosphorylation that adversely affect peripheral auditory mechanisms. This body of evidence is solidified by data derived from temporal bone and genetic studies, biochemical, molecular biologic, behavioral, electroacoustic, and electrophysiological investigations.

Use of chemical warming packs during delivery room resuscitation is associated with decreased rates of hypothermia in very low-birth-weight neonates.

BACKGROUND: : Hypothermia is an independent contributor to neonatal mortality. All very low-birth-weight (VLBW) newborns have the potential to undergo cold stress or frank hypothermia during delivery room stabilization. Thus, clinicians aiming to maintain normothermia in VLBW neonates are compelled to use multiple adjuncts of unknown efficacy or safety. OBJECTIVE: : To evaluate the effectiveness of thermoregulation procedures in maintaining normothermia during delivery room resuscitation and to assess the impact of an unanticipated change in equipment at our institution on the admission temperatures of VLBW newborns. DESIGN/METHODS: : Institutional review board-approved, retrospective analysis of quality assurance data submitted to the Vermont-Oxford Network (VON) for 24 consecutive months starting January 2006. We compared the rate of hypothermia (admission temperature < 36.5°C) in our NICU during 2006 with the aggregate rates reported by VON. We then compared the rates of hypothermia and mean admission temperatures in our NICU during period 1 (when chemical warming packs were used routinely, in addition to plastic wrapping and warm blankets) and period 2 (after packs were discontinued owing to an incident of focal skin injury). RESULTS: : In 2006, 42% of VLBW babies in our NICU had an admission temperature of less than 36.5°C compared with the VON rate of 61% (interquartile range 48%, 76%). During period 1, 39% of 183 VLBW neonates were hypothermic compared with 68% of 103 during period 2 (P < .001). Mean admission temperatures during periods 1 and 2 were 36.5°C and 36.1°C, respectively (P < .001). A control chart showed the shift in temperatures occurring as period 2 began. No change in practice other than discontinuation of the warming packs was instituted during period 2. The incidence of temperatures greater than 38°C (hyperthermia) was 1.6% during period 1 and 1.0% during period 2. CONCLUSIONS: : The results associated with this isolated change in practice at our institution suggest that chemical warming packs were a useful adjunct in achieving above-average rates of normothermia during delivery room resuscitation of VLBW newborns. Their potential adverse effects should be weighed against the increased risk of mortality associated with hypothermia in this population.

Efficacy, Safety, and Usability of Remifentanil as Premedication for INSURE in Preterm Neonates.

Background: We previously reported a 67% extubation failure with INSURE (Intubation, Surfactant, Extubation) using morphine as analgosedative premedication. Remifentanil, a rapid- and short-acting narcotic, might be ideal for INSURE, but efficacy and safety data for this indication are limited. Objectives: To assess whether remifentanil premedication increases extubation success rates compared with morphine, and to evaluate remifentanil's safety and usability in a teaching hospital context. Methods: Retrospective review of remifentanil orders for premedication, at a large teaching hospital neonatal intensive care unit (NICU). We compared INSURE failure rates (needing invasive ventilation after INSURE) with prior morphine-associated rates. Additionally, we surveyed NICU staff to identify usability and logistic issues with remifentanil. Results: 73 remifentanil doses were administered to 62 neonates (mean 31.6 ± 3.8 weeks' gestation). Extubation was successful in 88%, vs. 33% with morphine premedication (p < 0.001). Significant adverse events included chest wall rigidity (4%), one case of cardiopulmonary resuscitation (CPR) post-surfactant, naloxone reversal (5%), and notable transient desaturation (34%). Among 137 completed surveys, 57% indicated concerns, including delayed drug availability (median 1.1 h after order), rapid desaturations narrowing intubation timeframes and hindering trainee involvement, and difficulty with bag-mask ventilation after unsuccessful intubation attempts. Accordingly, 33% of ultimate intubators were attending neonatologists, versus 16% trainees. Conclusions: Remifentanil premedication was superior to morphine in allowing successful extubation, despite occasional chest wall rigidity and unfavorable conditions for trainees. We recommend direct supervision and INSURE protocols aimed at ensuring rapid intubation.

Relationships between otoacoustic emissions and auditory brainstem responses in neonates and young children: a correlation and factor analytical study.

OBJECTIVES: To establish relationships among transient evoked otoacoustic emission (TEOAE) and auditory brainstem response (ABR) variables in a sample of normal hearing neonates and young children, ranging in age from approximately 3 weeks to 4 years. STUDY DESIGN: Retrospective, non-randomized, cross-sectional analysis of clinical data obtained at a tertiary care medical center. METHODS: Pearson product moment and Spearman rank order correlation analyses to evaluate pairwise relationships between TEOAE variables, ABR variables and age; factor analysis, to identify the structural composition and dimensionality of these relationships. RESULTS: Significant pairwise correlations were obtained between variables within each test paradigm (TEOAEs, ABRs) and between ABR absolute and interpeak latencies with age. However, the most striking effect was the absence of strong correlations between ABR and TEOAE variables, indicating that these test measures provide independent information about auditory system integrity and sensitivity. Two factors, accounting for over 55% of the variance, characterized this data set: 1) a frequency-dependent OAE factor, which showed an inverse relation between biologic noise and whole wave percent reproducibility and half-octave band TEOAE amplitudes; and 2) a central nervous system (CNS) maturational factor, which showed an inverse relationship between age and certain absolute and interpeak ABR latency components. CONCLUSIONS: TEOAE and ABR test results provide unique and functionally independent information about normal auditory system integrity and sensitivity. Therefore, a combination of both tests is well suited for use within a pediatric test battery. These results confirm that biologic noise and age at test differentially affect OAE and ABR test measures, and both effects require consideration during data acquisition and interpretation.

Decreasing hypothermia during delivery room stabilization of preterm neonates.

BACKGROUND AND OBJECTIVE: Hypothermia during delivery room stabilization of very low birth weight (VLBW) newborns is independently associated with mortality, yet it occurred frequently both in collaborative networks and at our institution. We aimed to attain admission temperatures in the target range of 36 °C to 38 °C in ≥ 90% of inborn VLBW neonates through implementation of a thermoregulation bundle. METHODS: This quality improvement project extended over 60 consecutive months, using sequential plan-do-check-act cycles. During the 14 baseline months, we standardized temperature measurements and developed the Operation Toasty Tot thermoregulation bundle (including consistent head and torso wrapping with plastic, warmed blankets, and a closed stabilization room). We introduced this bundle in month 15 and added servo-controlled, battery-powered radiant warmers for stabilization and transfer in month 21. We provided results and feedback to staff throughout, using simple graphics and control charts. RESULTS: There were 164 inborn VLBW babies before and 477 after bundle implementation. Introduction and optimization of the bundle decreased the incidence of hypothermia, with rates remaining in the target range for the last 13 study months. The incidence of temperatures >38 °C was ~ 2% both before and after bundle implementation. CONCLUSIONS: This thermoregulation bundle resulted in sustained improvement in normothermia rates during delivery room stabilization of VLBW newborns. Our benchmark goal of ≥ 90% admission temperatures above 36 °C was met without increasing hyperthermia rates. Because these results compare favorably with those of recently published research or improvement collaboratives, we aim to maintain our performance through routine surveillance of admission temperatures.