The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation.

BACKGROUND: Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7-276/7 weeks' gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation. METHODS: This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24-276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks' postmenstrual age, discharge, death, or transfer. DISCUSSION: The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , trial identifier NCT05446272 , registered July 6, 2022.

Evaluation of NAVA-PAP in premature neonates with apnea of prematurity: minimal backup ventilation and clinically significant events.

Background: Neonates with apnea of prematurity (AOP) clinically deteriorate because continuous positive airway pressure (CPAP) provides inadequate support during apnea. Neurally adjusted ventilatory assist (NAVA) provides proportional ventilator support from the electrical activity of the diaphragm. When the NAVA level is 0 cmH2O/mcV (NAVA-PAP), patients receive CPAP when breathing and backup ventilation when apneic. This study evaluates NAVA-PAP and time spent in backup ventilation. Methods: This was a prospective, two-center, observational study of preterm neonates on NAVA-PAP for AOP. Ventilator data were downloaded after 24 h. The number of clinically significant events (CSEs) was collected. A paired t-test was used to perform statistical analysis. Results: The study was conducted on 28 patients with a gestational age of 25 ± 1.8 weeks and a study age of 28 ± 23 days. The number of CSEs was 4 ± 4.39/24 h. The patients were on NAVA-PAP for approximately 90%/min, switched to backup mode 2.5 ± 1.1 times/min, and spent 10.6 ± 7.2% in backup. Conclusion: Preterm neonates on NAVA-PAP had few CSEs with minimal time in backup ventilation.

Calendar reminders-A narrative poem.

All illnesses and disabilities are personal, family, workplace, community, and wider experiences as well as clinical signs, diagnoses, and treatment plans. This poem describes and evokes the writer's lived experience of Parkinson's disease-filled with fear, chaos, dread, hope-in relation to what had been for him a simple, routine, recurrent task. It is likely that the poem, on an often-taboo subject, will resonate with readers' own experiences. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Evaluating peak inspiratory pressures and tidal volume in premature neonates on NAVA ventilation.

Neurally adjusted ventilatory assist (NAVA) ventilation allows patients to determine their peak inspiratory pressure and tidal volume on a breath-by-breath basis. Apprehension exists about premature neonates' ability to self-regulate breath size. This study describes peak pressure and tidal volume distribution of neonates on NAVA and non-invasive NAVA. This is a retrospective study of stored ventilator data with exploratory analysis. Summary statistics were calculated. Distributional assessment of peak pressure and tidal volume were evaluated, overall and per NAVA level. Over 1 million breaths were evaluated from 56 subjects. Mean peak pressure was 16.4 ± 6.4 in the NAVA group, and 15.8 ± 6.4 in the NIV-NAVA group (t test, p < 0.001). Mean tidal volume was 3.5 ± 2.7 ml/kg.Conclusion:In neonates on NAVA, most pressures and volumes were within or lower than recommended ranges with pressure-limited or volume-guarantee ventilation. What is known: • Limiting peak inspiratory pressures or tidal volumes are the main strategies to minimize ventilator-induced lung injury in neonates. Neurally adjusted ventilatory assist allows neonates to regulate their own peak inspiratory pressures and tidal volumes on a breath-to-breath basis using neural feedback. What is new: • When neonates chose the size of their breaths based on neural feedback, the majority of peak inspiratory pressures and tidal volumes were within or lower than the recommended peak inspiratory pressure or tidal volume ranges with pressure-limited or volume guarantee ventilation.

Beta Testing of a Gestational Diabetes Risk Reduction Intervention for American Indian and Alaska Native Teens.

INTRODUCTION: American Indian and Alaska Native (AIAN) girls have double the risk of obesity, pregnancy, and gestational diabetes mellitus (GDM) than the general U.S. POPULATION: The purpose of this study was to beta test Stopping GDM (SGDM), a GDM risk reduction intervention for at-risk AIAN teens, before beginning a randomized controlled trial. METHOD: A sample of 11 AIAN mothers and daughters were recruited through an urban Indian health program. Daughters were at risk of GDM as assessed by a BMI ≥ 85th percentile. Pre- and posttest online questionnaires evaluated the online intervention (e-book and video). RESULTS: Mean pre- to posttest knowledge increased for mothers and daughters on diabetes prevention, reproductive health, and GDM knowledge. Daughters demonstrated an increased self-efficacy for healthy living and pregnancy planning. Satisfaction for the e-book, video, and online survey was moderately high to very high. DISCUSSION: The SGDM intervention is feasible and acceptable in AIAN mother-daughter dyads. These findings informed the SGDM intervention and the randomized controlled trial evaluation protocol.

Nasal continuous positive airway pressure versus noninvasive NAVA in preterm neonates with apnea of prematurity: a pilot study with a novel approach.

BACKGROUND: Neonates with apnea of prematurity often fail CPAP because it does not provide adequate support during apnea. NAVA provides proportional ventilator support based on electrical activity of the diaphragm. When the NAVA level is 0 cmH20/mcV, the patient receives minimal support above PEEP when breathing and backup ventilation when apneic. This study compares number of clinically significant events on CPAP versus noninvasive NAVA level 0. METHODS: Retrospective study of preterm neonates having apnea of prematurity on nasal CPAP. Patients were then placed on NAVA level 0. The number of events on each mode was collected. Statistics were paired t-test. RESULTS: Seventeen subjects with gestational age 26.1 ± 1.7 weeks, study age 19.5 ± 12.5 days. Events decreased from 17.9 ± 7.8 on CPAP to 10.2 ± 8.1 events on NAVA level 0 (p = 0.00047). CONCLUSIONS: NAVA level 0 reduced the number of clinically significant events compared with CPAP in premature neonates with apnea of prematurity.

Too short.

This brief poem is about the author's experience of loss and grief many years after the death of his father. It is thus about issues of family, loss, grief, time, and deep emotion. Family dynamics continue at both conscious and unconscious levels long after the person is deceased. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Effects of Changes in Apnea Time on the Clinical Status of Neonates on NIV-NAVA.

BACKGROUND: Apnea time allows the clinician to set a minimum spontaneous respiratory frequency when using noninvasive neurally-adjusted ventilatory assist (NIV-NAVA). Short apnea times may provide backup ventilation during periods of physiologic variability causing overventilation and suppression of spontaneous respiratory drive. Longer apnea times may allow more spontaneous ventilation but can result in insufficient respiratory support. The purpose of this study was to evaluate various apnea times in neonates on NIV-NAVA. METHODS: This was a 2-center, prospective, 1-factorial, interventional study of neonates <30 weeks gestational age on NIV-NAVA. Clinically important events and ventilator data were recorded for apnea times of 2 s and 5 s for 2 h each. RESULTS: 15 neonates (26 ± 1.6 weeks gestational age, birthweight 893 ± 202 g) were studied. When compared to the 5-s apnea time, the 2-s apnea time showed increased switches into backup ventilation from 0.5 switches/min to 2.5 switches/min (P < .001), and time spent in backup ventilation increased from 2%/min to 9%/min (P < .001). However, clinically important events decreased from 7 clinically important events per hour to 2 clinically important events per hour (P < .001). Measured breathing frequency increased with the 2-s apnea time but spontaneous breathing frequency, FIO2 , peak and minimum electrical activity of the diaphragm, and peak pressure remained unchanged. CONCLUSION: Short apnea times resulted in more switches into backup ventilation and longer time in backup ventilation but promoted clinical stability with fewer clinically important events in neonates ventilated with NIV-NAVA.

Increasing patient safety with neonates via handoff communication during delivery: a call for interprofessional health care team training across GME and CME.

Hospitals have struggled for years regarding the handoff process of communicating patient information from one health care professional to another. Ineffective handoff communication is recognized as a serious patient safety risk within the health care community. It is essential to take communication into consideration when examining the safety of neonates who require immediate medical attention after birth; effective communication is vital for positive patient outcomes, especially with neonates in a delivery room setting. Teamwork and effective communication across the health care continuum are essential for providing efficient, quality care that leads to favorable patient outcomes. Interprofessional simulation and team training can benefit health care professionals by improving interprofessional competence, defined as one's knowledge of other professionals including an understanding of their training and skillsets, and role clarity. Interprofessional teams that include members with specialization in obstetrics, gynecology, and neonatology have the potential to considerably benefit from training effective handoff and communication practices that would ensure the safety of the neonate upon birth. We must strive to provide the most comprehensive systematic, standardized, interprofessional handoff communication training sessions for such teams, through Graduate Medical Education and Continuing Medical Education that will meet the needs across the educational continuum.

Neurally Adjusted Ventilatory Assist for Noninvasive Support in Neonates.

Noninvasive ventilation (NIV) is frequently used in the NICU to avoid intubation or as postextubation support for spontaneously breathing infants experiencing respiratory distress. Neurally adjusted ventilatory assist (NAVA) is used as a mode of noninvasive support in which both the timing and degree of ventilatory assist are controlled by the patient. NIV-NAVA has been successfully used clinically in neonates as a mode of ventilation to prevent intubation, allow early extubation, and as a novel way to deliver nasal continuous positive airway pressure.

Our stories of illness.

In this poem, the author describes three types of stories after healing from his illness: restitution, quest, and chaos. (PsycINFO Database Record

Non-invasive ventilation with neurally adjusted ventilatory assist in newborns.

Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation in which both the timing and degree of ventilatory assist are controlled by the patient. Since NAVA uses the diaphragm electrical activity (Edi) as the controller signal, it is possible to deliver synchronized non-invasive NAVA (NIV-NAVA) regardless of leaks and to monitor continuously patient respiratory pattern and drive. Advantages of NIV-NAVA over conventional modes include improved patient-ventilator interaction, reliable respiratory monitoring and self-regulation of respiratory support. In theory, these characteristics make NIV-NAVA an ideal mode to provide effective, appropriate non-invasive support to newborns with respiratory insufficiency. NIV-NAVA has been successfully used clinically in neonates as a mode of ventilation to prevent intubation, to allow early extubation, and as a novel way to deliver nasal continuous positive airway pressure. The use of NAVA in neonates is described with an emphasis on studies and clinical experience with NIV-NAVA.

To Look or Not to Look: The Backward Engineering of Atrocity.

The organizational concept of "backward engineering" is used as a hermeneutic device to illuminate processes that were employed to implement the Holocaust. Here we study how rationality can be used in the service of irrationality. In particular, rationalized, engineered and bureaucratically organized inputs, throughputs, and outputs contain unconscious processes embodied in the engineering of atrocity. The process of the "conversion" of experiencing subjects into disposable objects is examined. Finally, the psychodynamics of the inability to look backward and take apart the vast supply chain leading to the actual killing are examined. An understanding of organizational psychodynamics contributes to the psychohistorical study of atrocity on a vast scale.

Implementation of a Neonatal Abstinence Syndrome Weaning Protocol: A Multicenter Cohort Study.

OBJECTIVES: To evaluate the generalizability of stringent protocol-driven weaning in improving total duration of opioid treatment and length of inpatient hospital stay after treatment of neonatal abstinence syndrome (NAS). METHODS: We conducted a retrospective cohort analysis of 981 infants who completed pharmacologic treatment of NAS with methadone or morphine from January 2012 through August 2014. Before July 2013, 3 of 6 neonatology provider groups (representing Ohio's 6 children's hospitals) directed NAS nursery care by using group-specific treatment protocols containing explicit weaning guidelines. In July 2013, a standardized weaning protocol was adopted by all 6 groups. Statistical analysis was performed to identify effects of adoption of the multicenter weaning protocol on total duration of opioid treatment and length of hospital stay at the protocol-adopting sites and at the sites with preexisting protocol-driven weaning. RESULTS: After adoption of the multicenter protocol, infants treated by the 3 groups previously without stringent weaning guidelines experienced shorter duration of opioid treatment (23.0 vs 34.0 days, P < .001) and length of inpatient hospital stay (23.7 vs 31.6 days, P < .001). Protocol-adopting sites also experienced a lower rate of adjunctive drug therapy (5% vs 21%, P = .004). Outcomes were sustained by the 3 groups who initially had specific weaning guidelines after multicenter adoption (duration of treatment = 17.0 days and length of hospital stay = 23.3 days). CONCLUSIONS: Adoption of a stringent weaning protocol resulted in improved NAS outcomes, demonstrating generalizability of the protocol-driven weaning approach. Opportunity remains for additional protocol refinement.

A multicenter cohort study of treatments and hospital outcomes in neonatal abstinence syndrome.

OBJECTIVES: To compare pharmacologic treatment strategies for neonatal abstinence syndrome (NAS) with respect to total duration of opioid treatment and length of inpatient hospital stay. METHODS: We conducted a cohort analysis of late preterm and term neonates who received inpatient pharmacologic treatment of NAS at one of 20 hospitals throughout 6 Ohio regions from January 2012 through July 2013. Physicians managed NAS using 1 of 6 regionally based strategies. RESULTS: Among 547 pharmacologically treated infants, we documented 417 infants managed using an established NAS weaning protocol and 130 patients managed without protocol-driven weaning. Regardless of the treatment opioid chosen, when we accounted for hospital variation, infants receiving protocol-based weans experienced a significantly shorter duration of opioid treatment (17.7 vs. 32.1 days, P < .0001) and shorter hospital stay (22.7 vs. 32.1 days, P = .004). Among infants receiving protocol-based weaning, there was no difference in the duration of opioid treatment or length of stay when we compared those treated with morphine with those treated with methadone. Additionally, infants treated with phenobarbital were treated with the drug for a longer duration among those following a morphine-based compared with methadone-based weaning protocol. (P ≤ .002). CONCLUSIONS: Use of a stringent protocol to treat NAS, regardless of the initial opioid chosen, reduces the duration of opioid exposure and length of hospital stay. Because the major driver of cost is length of hospitalization, the implications for a reduction in cost of care for NAS management could be substantial.

Application of neurally adjusted ventilatory assist in neonates.

Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm (Edi) as a neural trigger to synchronize mechanical ventilatory breaths with the patient's neural respiratory drive. Using this signal enables the ventilator to proportionally support the patient's instantaneous drive on a breath-by-breath basis. Synchrony can be achieved even in the presence of significant air leaks, which make this an attractive choice for invasive and non-invasive ventilation of the neonate. This paper describes the Edi signal, neuroventilatory coupling, and patient-ventilator synchrony including the functional concept of NAVA. Safety features, NAVA terminology, and clinical application of NAVA to unload respiratory musculature are presented. The use of the Edi signal as a respiratory vital sign for conventional ventilation is discussed. The results of animal and adult studies are briefly summarized and detailed descriptions of all NAVA-related research in pediatric and neonatal patients are provided. Further studies are needed to determine whether NAVA will have significant impact on the overall outcomes of neonates.

Interfaces between electronic medical record (EMR/EHR) technology and people in American medicine: insight. imagination, and relationships in clinical practice.

This paper explores the contexts and relationships in which EMR/EHR technology is used in healthcare settings. It approaches the EMR/EHR as an issue in clinical ethics. The author recognizes the immense contribution that healthcare informatics makes to coordinating and integrating medical care at the level of individual physician, nurse, and institutions. At the same time the author raises a cautionary note about some unrecognized dimensions of the use and experience of the EMR/EHR. The author argues that the EMR/EHR can consciously and unconsciously become an instrument of assembly line-like physician "productivity" and "production reports" that depersonalize patient and physician alike. Construed this way, the EMR/EHR can narrow the clinician's imagination, relationships, clinical decision-making, and documentation into oversimplified, and potentially distorting, clinical narratives and categories such as fit into CPT, ICD-9, DRG, DSM-IV and other codes, EBM protocols, and clinical algorithms. By contrast, the author uses a vignette and one of his own clinical poems to illustrate the rich weave of relationship and meaning that are foreground rather than background in clinical assessment, decision-making, treatment, outcome, and satisfaction. The author concludes with a call to imaginatively use the EMR/EHR as an instrument of physician-patient communication, and to include in it and make available vital narrative data (evidence) about patient, family, culture, occupation, socioeconomic status, physician, disease, and their relationships.