Analysis of the Perinatal Care System in a Remote and Mountainous District of Nepal.

INTRODUCTION: Despite significant improvements in recent years, maternal and neonatal health outcomes remain poor in many regions of the world. One such area is in the remote mountainous regions of Nepal. The purpose of this study is to describe the current antenatal care practices and delivery support in a mountainous district of Nepal. METHODS: This study took place in Solukhumbu District between December 2015 and February 2018. A household survey was created using evidence-based maternal and neonatal care indicators. Women who had delivered within the previous two years were surveyed regarding antenatal and delivery care they received. A standardized health facility survey was used to evaluate the operational status of health facilities. The study was approved by the Nepal Ministry of Health and the University of Utah IRB. RESULTS: A total of 487 households and 19 facilities were surveyed. 35.7% (174/487) of deliveries occurred in a health facility (hospital, primary health care center or birthing center). 35.2% (171/486) of deliveries were attended by a skilled birth attendant. 52.8% (47/89) of women who did not deliver in a facility noted that transportation issues and not having sufficient time to travel during labor prevented them from delivering in a facility. No health posts had staff trained in obstetric and neonatal emergencies. DISCUSSION: The majority of women in Solukhumbu District do not receive high quality antenatal and delivery care. An intervention that would make antenatal care and delivery support more accessible could improve maternal and infant outcomes in this district and other similar regions.

Evaluation of a Tennessee statewide initiative to reduce early elective deliveries using quasi-experimental methods.

BACKGROUND: Concerted quality improvement (QI) efforts have been taken to discourage the practice of early elective deliveries (EEDs), but few studies have robustly examined the impact of directed QI interventions in reducing EED practices. Using quasi-experimental methods, we sought to evaluate the impact of a statewide QI intervention to reduce the practice of EEDs. METHODS: Retrospective cohort study of vital records data (2007 to 2013) for all singleton births occurring ≥36 weeks in 66 Tennessee hospitals grouped into three QI cohorts. We used interrupted-time series to estimate the effect of the QI intervention on the likelihood of an EED birth statewide, and by hospital cohort. We compared the distribution of hospital EED percentages pre- and post-intervention. Lastly, we used multivariable logistic regression to estimate the effect of QI interventions on maternal and infant outcomes. RESULTS: Implementation of the QI intervention was associated with significant declines in likelihood of EEDs immediately following the intervention (odds ratio, OR = 0.72; p < 0.001), but these results varied by hospital cohort. Hospital risk-adjusted EED percentages ranged from 1.6-13.6% in the pre-intervention period, which significantly declined to 2.2-9.6% in the post-intervention period (p < 0.001). The QI intervention was also associated with significant reductions in operative vaginal delivery and perineal laceration, and immediate infant ventilation, but increased NICU admissions. CONCLUSIONS: A statewide QI intervention to reduce EEDs was associated with modest but significant declines in EEDs beyond concurrent and national trends, and showed mixed results in related infant and maternal outcomes.

Building the Driver Diagram: A Mixed-Methods Approach to Identify Causes of Unplanned Extubations in a Large Neonatal ICU.

BACKGROUND: The key driver diagram (KDD) is an important tool used by improvement teams to guide and frame their work. Methods to build a KDD when little relevant literature or reliable local data exist are poorly described. This article describes the process used in our neonatal ICU (NICU) to build a KDD to decrease unplanned extubations (UE) in chronically ventilated infants. METHODS: Twenty-seven factors hypothesized to be associated with UE in our NICU were identified. An expert panel of 33 staff members completed three rounds of a modified Delphi process administered through an online interface. After the third round, panel members provided suggestions for interventions to target all factors meeting criteria for consensus. These qualitative data were analyzed by inductive thematic analysis. A follow-up survey to all panel members was used to assess the feasibility of this process for future use. RESULTS: After three Delphi rounds, 14 factors met consensus and eight main interventions were identified through thematic analysis. These data were used to build a KDD for testing. All participants who completed the follow-up survey (20/20) stated willingness to participate in this process in the future and 18/20 (90%) stated they would be "more willing" or "much more willing" to support interventions developed using this process. CONCLUSION: A novel mixed-methods approach was used to generate a KDD combining a Delphi process with thematic analysis. This approach provides improvement teams a rigorous and reproducible method to understand local context, generate consensus KDDs, and improve local buy-in for improvement interventions.

Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants.

OBJECTIVE: To determine the rate of adverse events associated with endotracheal intubation in newborns and modifiable factors contributing to these events. STUDY DESIGN: We conducted a prospective, observational study in a 100-bed, academic, level IV neonatal intensive care unit from September 2013 through June 2014. We collected data on intubations using standardized data collection instruments with validation by medical record review. Intubations in the delivery or operating rooms were excluded. The primary outcome was an intubation with any adverse event. Adverse events were defined and tracked prospectively as nonsevere or severe. We measured clinical variables including number of attempts to successful intubation and intubation urgency (elective, urgent, or emergent). We used logistic regression models to estimate the association of these variables with adverse events. RESULTS: During the study period, 304 intubations occurred in 178 infants. Data were available for 273 intubations (90%) in 162 patients. Adverse events occurred in 107 (39%) intubations with nonsevere and severe events in 96 (35%) and 24 (8.8%) intubations, respectively. Increasing number of intubation attempts (OR 2.1, 95% CI, 1.6-2.6) and emergent intubations (OR 4.7, 95% CI, 1.7-13) were predictors of adverse events. The primary cause of emergent intubations was unplanned extubation (62%). CONCLUSIONS: Adverse events are common in the neonatal intensive care unit, occurring in 4 of 10 intubations. The odds of an adverse event doubled with increasing number of attempts and quadrupled in the emergent setting. Quality improvement efforts to address these factors are needed to improve patient safety.

A quality improvement initiative for neonatal hypoglycemia screening and management in a level III neonatal intensive care unit.

OBJECTIVE: To bring screening and management of neonatal hypoglycemia in alignment with the 2011 AAP hypoglycemia clinical report METHODS: A multidisciplinary team developed a quality improvement initiative for neonatal hypoglycemia in neonates ≥35 weeks gestational age in a Level III neonatal intensive care unit between July 2020 and December 2021. A key driver diagram identified interventions for plan-do-study-act testing with corresponding measures to implement a hypoglycemia management protocol and improve adherence to AAP guidelines. RESULTS: Time to first blood glucose measurement increased from 49.8 to 122.7 min of life and time to first enteral feed decreased from 14.2 to 3.6 h of life. Neonates receiving intravenous dextrose decreased from 97.1 to 24.7% and discharge rates as a mother-neonate dyad increased from 35 to 62.4%. CONCLUSIONS: Adherence to the AAP guidelines improved during testing and implementation of a hypoglycemia protocol and was associated with an increased mother-neonate dyad discharge rate.

A novel RAD51 variant resulting in Fanconi anemia identified in an infant with multiple congenital anomalies.

Fanconi anemia, FA, is a rare, multi-system disease caused by pathogenic variants in DNA repair genes. We report a novel RAD51 variant in an infant with FA whose tracheobronchomalacia has not been described in FA. His severe presentation expands the phenotype of RAD51-associated FA, reported only in three patients previously.

Open-Source Artificial Intelligence System Supports Diagnosis of Mendelian Diseases in Acutely Ill Infants.

Mendelian disorders are prevalent in neonatal and pediatric intensive care units and are a leading cause of morbidity and mortality in these settings. Current diagnostic pipelines that integrate phenotypic and genotypic data are expert-dependent and time-intensive. Artificial intelligence (AI) tools may help address these challenges. Dx29 is an open-source AI tool designed for use by clinicians. It analyzes the patient's phenotype and genotype to generate a ranked differential diagnosis. We used Dx29 to retrospectively analyze 25 acutely ill infants who had been diagnosed with a Mendelian disorder, using a targeted panel of ~5000 genes. For each case, a trio (proband and both parents) file containing gene variant information was analyzed, alongside patient phenotype, which was provided to Dx29 by three approaches: (1) AI extraction from medical records, (2) AI extraction with manual review/editing, and (3) manual entry. We then identified the rank of the correct diagnosis in Dx29's differential diagnosis. With these three approaches, Dx29 ranked the correct diagnosis in the top 10 in 92-96% of cases. These results suggest that non-expert use of Dx29's automated phenotyping and subsequent data analysis may compare favorably to standard workflows utilized by bioinformatics experts to analyze genomic data and diagnose Mendelian diseases.

A pilot study to determine the incidence, type, and severity of non-routine events in neonates undergoing gastrostomy tube placement.

BACKGROUND: Non-routine events (NRE) are defined as any suboptimal occurrences in a process being measured in the opinion of the reporter and comes from the field of human factors engineering. These typically occur well up-stream of an adverse event and NRE measurement has not been applied to the complex context of neonatal surgery. We sought to apply this novel safety event measurement methodology to neonates in the NICU undergoing gastrostomy tube placement. METHODS: A prospective pilot study was conducted between November 2016 and August 2020 in the Level IV NICU and the pediatric operating rooms of an urban academic children's hospital to determine the incidence, severity, impact, and contributory factors of clinician-reported non-routine events (NREs, i.e., deviations from optimal care) and 30-day NSQIP occurrences in neonates receiving a G-tube. RESULTS: Clinicians reported at least one NRE in 32 of 36 (89%) G-tube cases, averaging 3.0 (Standard deviation: 2.5) NRE reports per case. NSQIP-P review identified 7 cases (19%) with NSQIP-P occurrences and each of these cases had multiple reported NREs. One case in which NREs were not reported was without NSQIP-P occurrences. The odds ratio of having a NSQIP-P occurrence with the presence of an NRE was 0.695 (95% CI 0.06-17.04). CONCLUSION: Despite being considered a "simple" operation, >80% of neonatal G-tube placement operations had at least one reported NRE by an operative team member. In this pilot study, NRE occurrence was not significantly associated with the subsequent reporting of an NSQIP-P occurrence. Understanding contributory factors of NREs that occur in neonatal surgery may promote surgical safety efforts and should be evaluated in larger and more diverse populations. LEVEL OF EVIDENCE: IV.

Developing a Unit-Based Quality Improvement Program in a Large Neonatal ICU.

BACKGROUND: Quality improvement (QI) methods have been widely adopted in health care. Although theoretical frameworks and models for organizing successful QI programs have been described, few reports have provided practical examples to link existing QI theory to building a unit-based QI program. The purpose of this report is to describe the authors' experience in building QI infrastructure in a large neonatal ICU (NICU). METHODS: A unit-based QI program was developed with the goal of fostering the growth of high-functioning QI teams. This program was based on six pillars: shared vision for QI, QI team capacity, QI team capability, actionable data for improvement, culture of improvement, and QI team integration with external collaboratives. Multiple interventions were developed, including a QI dashboard to align NICU metrics with unit and hospital quality goals, formal training for QI leaders, QI coaches imbedded in project teams, a day-long QI educational workshop to introduce QI methodology to unit staff, and a secure, Web-based QI data infrastructure. RESULTS: Over a five-year period, this QI infrastructure brought organization and support for individual QI project teams and improved patient outcomes in the unit. Two case studies are presented, describing teams that used support from the QI infrastructure. The Infection Prevention team reduced central line-associated bloodstream infections from 0.89 to 0.36 infections per 1,000 central line-days. The Nutrition team decreased the percentage of very low birth weight infants discharged with weights less than the 10th percentile from 51% to 40%. CONCLUSION: The clinicians provide a pragmatic example of incorporating QI organizational and contextual theory into practice to support the development of high-functioning QI teams and build a unit-based QI program.

Increasing Volume-Targeted Ventilation Use in the NICU.

BACKGROUND: In preterm infants who require mechanical ventilation (MV), volume-targeted ventilation (VTV) modes are associated with lower rates of bronchopulmonary dysplasia compared with pressure-limited ventilation. Bronchopulmonary dysplasia rates in our NICU were higher than desired, prompting quality improvement initiatives to improve MV by increasing the use of VTV. METHODS: We implemented and tested interventions over a 3-year period. Primary outcomes were the percentage of conventional MV hours when any-VTV mode was used and the percentage of conventional MV hours when an exclusively VTV mode was used. Exclusively VTV modes were modes in which all breaths were volume targeted. We evaluated outcomes during 3 project periods: baseline (May 2016-December 2016); epoch 1 (December 2016-October 2018), increasing the use of any-VTV mode; and epoch 2 (October 2018-November 2019), increasing the use of exclusively VTV modes. RESULTS: Use of any-VTV mode increased from 18 694 of 22 387 (83%) MV hours during baseline to 72 846 of 77 264 (94%) and 58 174 of 60 605 (96%) MV hours during epochs 1 and 2, respectively (P < .001). Use of exclusively VTV increased from 5967 of 22 387 (27%) during baseline to 47 364 of 77 264 (61%) and 46 091 of 60 605 (76%) of all conventional MV hours during epochs 1 and 2, respectively (P < .001). In statistical process control analyses, multiple interventions were associated with improvements in primary outcomes. Measured clinical outcomes were unchanged. CONCLUSIONS: Quality improvement interventions were associated with improved use of VTV but no change in measured clinical outcomes.

Postnatal estradiol up-regulates lung nitric oxide synthases and improves lung function in bronchopulmonary dysplasia.

RATIONALE: Nitric oxide (NO) plays an important role in lung development and perinatal lung function, and pulmonary NO synthases (NOS) are decreased in bronchopulmonary dysplasia (BPD) following preterm birth. Fetal estradiol levels increase during late gestation and estradiol up-regulates NOS, suggesting that after preterm birth estradiol deprivation causes attenuated lung NOS resulting in impaired pulmonary function. OBJECTIVE: To test the effects of postnatal estradiol administration in a primate model of BPD over 14 days after delivery at 125 days of gestation (term = 185 d). METHODS: Cardiopulmonary function was assessed by echocardiography and whole body plethysmography. Lung morphometric and histopathologic analyses were performed, and NOS enzymatic activity and abundance were measured. MEASUREMENTS AND MAIN RESULTS: Estradiol caused an increase in blood pressure and ductus arteriosus closure. Expiratory resistance and lung compliance were also improved, and this occurred before spontaneous ductal closure. Furthermore, both oxygenation and ventilation indices were improved with estradiol, and the changes in lung function and ventilatory support requirements persisted throughout the study period. Whereas estradiol had negligible effect on indicators of lung inflammation and on lung structure assessed after the initial 14 days of ventilatory support, it caused an increase in lung neuronal and endothelial NOS enzymatic activity. CONCLUSIONS: In a primate model of BPD, postnatal estradiol treatment had favorable cardiovascular impact, enhanced pulmonary function, and lowered requirements for ventilatory support in association with an up-regulation of lung NOS. Estradiol may be an efficacious postnatal therapy to improve lung function and outcome in preterm infants.

Implementation of a probiotic protocol to reduce rates of necrotizing enterocolitis.

OBJECTIVE: To utilize a probiotic protocol to achieve a 50% reduction in rates of necrotizing enterocolitis (NEC) ≥ Bell Stage 2 within 2 years of protocol implementation. STUDY DESIGN: Literature review guided probiotic selection and protocol design. A driver diagram identified key drivers to achieve our aim. A U chart followed monthly NEC ≥ Bell Stage 2 per 100 patient days and per monthly admissions. The process measure was protocol compliance and the balancing measure was probiotic sepsis. RESULTS: NEC ≥ Bell Stage 2 decreased from 0.14 to 0.04 per 100 patient days in infants < 33 weeks gestation or <1500 g, or a yearly rate of 7-2%. Protocol compliance was 98% and there were no cases of probiotic sepsis. CONCLUSION: Implementation of a probiotic protocol was associated with a decrease in rates of NEC.

Improving neonatal resuscitation in Tennessee: a large-scale, quality improvement project.

OBJECTIVE: We report a statewide collaborative quality initiative to improve resuscitation and stabilization practices following introduction of the 6th edition of the Neonatal Resuscitation Program. METHODS: Participants drafted a consensus toolkit of interventions and corresponding measures. Hospital teams collected baseline data, and implemented changes using PDSA-cycles and statistical process control charts. RESULTS: Nine Tennessee NICUs submitted data on 3771 resuscitations. "Special cause" improvements were achieved and sustained for pre-resuscitation checklists (77-90%) and team briefings (80-92%). Time to intravenous access (50-42 min), glucose infusion initiation (73-60 min), and antibiotic dosing (113-98 min) were also significantly reduced. Teams were unable to meet new NRP oxygen saturation targets. Improvements in post-resuscitation debriefing were not sustained, while communication with parents declined significantly (68-60%). CONCLUSION: Large-scale collaboration facilitated statewide implementation of new guidelines, while highlighting under-appreciated systems challenges among competing resource demands.

Implementing Strategies to Identify and Mitigate Adverse Safety Events: A Case Study with Unplanned Extubations.

BACKGROUND: Patient safety events result from failures in complex health care delivery processes. To ensure safety, teams must implement ways to identify events that occur in a nonrandom fashion and respond in a timely manner. To illustrate this, one children's hospital's experience with an outbreak of unplanned extubations (UEs) in the neonatal ICU (NICU) is described. METHODS: The quality improvement team measured UEs using three complementary data streams. Interventions to decrease the rate of UE were tested with success. Three statistical process control (SPC) charts (u-chart, g-chart, and an exponentially weighted moving average [EWMA] chart) were used for real-time monitoring. RESULTS: From July 2015 to May 2016, the UE rate was stable at 1.1 UE/100 ventilator days. In early June 2016, a cluster of UEs, including four events within one week, was observed. Two of three SPC charts showed special cause variation, although at different time points. The EWMA chart alerted the team more than two weeks earlier than the u-chart. Within days of discovering the outbreak, the team identified that the hospital had replaced the tape used to secure endotracheal tubes with a nearly identical product. After multiple tape products were tested over the next month, the team selected one that returned the system to a state of stability. CONCLUSION: Ongoing monitoring using SPC charts allowed early detection and rapid mitigation of an outbreak of UEs in the NICU. This highlights the importance of continuous monitoring using tools such as SPC charts that can alert teams to both improvement and worsening of processes.

A Statewide Quality Improvement Collaborative to Increase Breastfeeding Rates in Tennessee.

BACKGROUND AND OBJECTIVES: Tennessee has low breastfeeding rates and has identified opportunities for improvement to enhance maternity practices to support breastfeeding mothers. We sought a 10% relative increase in the aggregate Joint Commission measure of breastfeeding exclusivity at discharge (TJC PC-05) by focusing on high-reliability (≥90%) implementation of processes that promote breastfeeding in the delivery setting. METHODS: A statewide, multidisciplinary development team reviewed evidence from the WHO-UNICEF "Ten Steps to Successful Breastfeeding" to create a consensus toolkit of process indicators aligned with the Ten Steps. Hospitals submitted monthly TJC PC-05 data for 6 months while studying local implementation of the Ten Steps to identify improvement opportunities, and for an additional 11 months while conducting tests of change to improve Ten Steps implementation using Plan-Do-Study-Act cycles, local process audits, and control charts. Data were aggregated at the state level and presented at 12 monthly webinars, 3 regional learning sessions, and 1 statewide meeting where teams shared their local data and implementation experiences. RESULTS: Thirteen hospitals accounting for 47% of live births in Tennessee submitted data on 31,183 mother-infant dyads from August 1, 2012, to December 31, 2013. Aggregate monthly mean PC-05 demonstrated "special cause" improvement increasing from 37.1% to 41.2%, an 11.1% relative increase. Five hospitals reported implementation of ≥5 of the Ten Steps and two hospitals reported ≥90% reliability on ≥5 of the Ten Steps using locally designed process audits. CONCLUSION: Using large-scale improvement methodology, a successful statewide collaborative led to >10% relative increase in breastfeeding exclusivity at discharge in participating Tennessee hospitals. Further opportunities for improvement in implementing breastfeeding supportive practices were identified.

Rapid resolution of hyperammonemia in neonates using extracorporeal membrane oxygenation as a platform to drive hemodialysis.

OBJECTIVE: We aimed to clarify the impact of extracorporeal membrane oxygenation (ECMO) as a platform to drive hemodialysis (HD) for ammonia clearance on outcomes of neonates with severe hyperammonemia. STUDY DESIGN: All neonates treated for hyperammonemia at a single children's hospital between 1992 and 2016 were identified. Patient characteristics and outcomes were compared between those receiving medical management or ECMO/HD. RESULT: Twenty-five neonates were treated for hyperammonemia, of which 13 (52%) received ECMO/HD. Peak ammonia levels among neonates treated with ECMO/HD were significantly higher than those medically managed (1041 [IQR 902-1581] µmol/L versus 212 [IQR 110-410] µmol/L; p = 0.009). Serum ammonia levels in the ECMO/HD cohort declined to the median of medically managed within 4.5 (IQR 2.9-7.0) hours and normalized within 7.3 (IQR 3.6-13.5) hours. All neonates survived ECMO/HD, and nine (69.2%) survived to discharge. CONCLUSION: ECMO/HD is an effective adjunct to rapidly clear severe hyperammonemia in newborns, reducing potential neurodevelopmental morbidity.

Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit.

OBJECTIVE: To improve patient safety in our NICU by decreasing the incidence of intubation-associated adverse events (AEs). METHODS: We sequentially implemented and tested 3 interventions: standardized checklist for intubation, premedication algorithm, and computerized provider order entry set for intubation. We compared baseline data collected over 10 months (period 1) with data collected over a 10-month intervention and sustainment period (period 2). Outcomes were the percentage of intubations containing any prospectively defined AE and intubations with bradycardia or hypoxemia. We followed process measures for each intervention. We used risk ratios (RRs) and statistical process control methods in a times series design to assess differences between the 2 periods. RESULTS: AEs occurred in 126/273 (46%) intubations during period 1 and 85/236 (36%) intubations during period 2 (RR = 0.78; 95% confidence interval [CI], 0.63-0.97). Significantly fewer intubations with bradycardia (24.2% vs 9.3%, RR = 0.39; 95% CI, 0.25-0.61) and hypoxemia (44.3% vs 33.1%, RR = 0.75, 95% CI 0.6-0.93) occurred during period 2. Using statistical process control methods, we identified 2 cases of special cause variation with a sustained decrease in AEs and bradycardia after implementation of our checklist. All process measures increased reflecting sustained improvement throughout data collection. CONCLUSIONS: Our interventions resulted in a 10% absolute reduction in AEs that was sustained. Implementation of a standardized checklist for intubation made the greatest impact, with reductions in both AEs and bradycardia.

Does the American College of Surgeons National Surgical Quality Improvement Program pediatric provide actionable quality improvement data for surgical neonates?

BACKGROUND/PURPOSE: The purpose of this project was to examine the American College of Surgeons National Surgical Quality Improvement Program Pediatric (ACSNSQIP-P) Participant Use File (PUF) to compare risk-adjusted outcomes of neonates versus other pediatric surgical patients. METHODS: In the ACS-NSQIP-P 2012-2013 PUF, patients were classified as preterm neonate, term neonate, or nonneonate at the time of surgery. The primary outcomes were 30-day mortality and composite morbidity. Patient characteristics significantly associated with the primary outcomes were used to build a multivariate logistic regression model. RESULTS: The overall 30-day mortality rate for preterm neonates, term neonate, and nonneonates was 4.9%, 2.0%, 0.1%, respectively (p<0.0001). The overall 30-day morbidity rate for preterm neonates, term neonates, and nonneonates was 27.0%, 17.4%, 6.4%, respectively (p<0.0001). After adjustment for preoperative and operative risk factors, both preterm (adjusted odds ratio, 95% CI: 2.0, 1.4-3.0) and term neonates (aOR, 95% CI: 1.9, 1.2-3.1) had a significantly increased odds of 30-day mortality compared to nonneonates. CONCLUSION: Surgical neonates are a cohort who are particularity susceptible to postoperative morbidity and mortality after adjusting for preoperative and operative risk factors. Collaborative efforts focusing on surgical neonates are needed to understand the unique characteristics of this cohort and identify the areas where the morbidity and mortality can be improved.