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Background and Aim: The Helping Babies Breathe program gave major reductions in perinatal mortality in Tanzania from 2009 to 2012. We aimed to study whether this effect was sustained, and whether resuscitation skills changed with continued frequent training., Methods: We analysed prospective data covering all births (n = 19,571) at Haydom Lutheran Hospital in Tanzania from July 2013 -June 2018. Resuscitation training was continued during this period. All deliveries were monitored by an observer recording the timing of events and resuscitation interventions. Heart rate was recorded by dry-electrode ECG and bag-mask-ventilation by sensors attached to the resuscitator device. We analyzed changes over time in outcomes, use of resuscitation interventions and performance of resuscitation using binary regression models with the log-link function to obtain adjusted relative risks., Results: With introduction of user fees for deliveries since 2014, the number of deliveries decreased by 30% from start to the end of the five-year period. An increase in low heart rate at birth and need for bag-mask-ventilation indicate a gradual selection of more vulnerable newborns delivered in the hospital over time. Despite this selection, newborn deaths <24 hours did not change significantly and was maintained at an average of 8.8/1000 live births. The annual reductions in relative risk for perinatal death adjusted for vulnerability factors was 0.84 (95%CI 0.76-0.94). During the five-year period, longer duration of bag-mask ventilation sequences without interruption was observed. Delivered tidal volumes were increased and mask leak was decreased during ventilation. The time to initiation or total duration of ventilation did not change significantly., Conclusion: The reduction in 24-hour newborn mortality after introduction of Helping Babies Breathe was maintained, and a further decrease over the five-year period was evident when analyses were adjusted for vulnerability of the newborns. Perinatal survival and performance of ventilation were significantly improved., Competing Interests: Joar Eilevstjønn is a paid employee for Laerdal Medicals. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objective: To trace and document smaller changes in perinatal survival over time., Design: Prospective observational study, with retrospective analysis., Setting: Labor ward and operating theater at Haydom Lutheran Hospital in rural north-central Tanzania., Participants: All women giving birth and birth attendants., Intervention: Helping Babies Breathe (HBB) simulation training on newborn care and resuscitation and some other efforts to improve perinatal outcome., Main Outcome Measure: Perinatal survival, including fresh stillbirths and early (24-h) newborn survival., Result: The variable life-adjusted plot and cumulative sum chart revealed a steady improvement in survival over time, after the baseline period. There were some variations throughout the study period, and some of these could be linked to different interventions and events., Conclusion: To our knowledge, this is the first time statistical process control methods have been used to document changes in perinatal mortality over time in a rural Sub-Saharan hospital, showing a steady increase in survival. These methods can be utilized to continuously monitor and describe changes in patient outcomes.

Abstract Background Annually, 1.5 million intrapartum-related deaths occur; fresh stillbirths and early newborn deaths. Most of these deaths are preventable with skilled ventilation starting within the first minute of life. Helping Babies Breathe is an educational program shown to improve simulated skills in newborn resuscitation. However, translation into clinical practice remains a challenge. The aim was to describe changes in clinical resuscitation and perinatal outcomes (i.e., fresh stillbirths and 24-h newborn deaths) after introducing a novel simulator (phase 1) and then local champions (phase 2) to facilitate ongoing Helping Babies Breathe skill and scenario simulation training. Methods This is a 3-year prospective before/after (2 phases) clinical observational study in Tanzania. Research assistants observed all deliveries from September 2015 through August 2018 and recorded labor/newborn information and perinatal outcomes. A novel simulator with automatic feedback to stimulate self-guided skill training was introduced in September 2016. Local champions were introduced in October 2017 to motivate midwives for weekly training, also team simulations. Results The study included 10,481 births. Midwives had practiced self-guided skill training during the last week prior to a real newborn resuscitation in 34% of cases during baseline, 30% in phase 1, and 71% in phase 2. Most real resuscitations were provided by midwives, increasing from 66% in the baseline, to 77% in phase 1, and further to 83% in phase 2. The median time from birth to first ventilation decreased between baseline and phase 2 from 118 (85–165) to 101 (72–150) s, and time pauses during ventilation decreased from 28 to 16%. Ventilations initiated within the first minute did not change significantly (13–16%). The proportion of high-risk deliveries increased during the study period, while perinatal mortality remained unchanged. Conclusions This study reports a gradual improvement in real newborn resuscitation skills after introducing a novel simulator and then local champions. The frequency of trainings increased first after the introduction of motivating champions. Time from birth to first ventilation decreased; still, merely 16% of newborns received ventilation within the first minute as recommended. This is a remaining challenge that may require more targeted team-scenario training and quality improvement efforts to improve.

Abstract Background The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. Methods The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99. Discussion Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope. Trial registration Name of Trial Registry: ISRCTN Registry. Trial registration number: ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.

Abstract Background Fresh stillbirths (FSB) and very early neonatal deaths (VEND) are important global challenges with 2.6 million deaths annually. The vast majority of these deaths occur in low- and low-middle income countries. Assessment of the fetal well-being during pregnancy, labour, and birth is normally conducted by monitoring the fetal heart rate (FHR). The heart rate of newborns is reported to increase shortly after birth, but a corresponding trend in how FHR changes just before birth for normal and adverse outcomes has not been studied. In this work, we utilise FHR measurements collected from 3711 labours from a low and low-middle income country to study how the FHR changes towards the end of the labour. The FHR development is also studied in groups defined by the neonatal well-being 24 h after birth. Methods A signal pre-processing method was applied to identify and remove time periods in the FHR signal where the signal is less trustworthy. We suggest an analysis framework to study the FHR development using the median FHR of all measured heart rates within a 10-min window. The FHR trend is found for labours with a normal outcome, neonates still admitted for observation and perinatal mortality, i.e. FSB and VEND. Finally, we study how the spread of the FHR changes over time during labour. Results When studying all labours, there is a drop in median FHR from 134 beats per minute (bpm) to 119 bpm the last 150 min before birth. The change in FHR was significant ( $$p

Safer Births Bundle of Care (SBBC) consists of innovative clinical and training tools for improved labour care and newborn resuscitation, integrated with new strategies for continuous quality improvement. After implementation, we hypothesised a reduction in 24-h newborn deaths, fresh stillbirths, and maternal deaths by 50%, 20%, and 10%, respectively. This is a 3-year stepped-wedged cluster randomised implementation study, including 30 facilities within five regions in Tanzania. Data collectors at each facility enter labour and newborn care indicators, patient characteristics and outcomes. This halfway evaluation reports data from March 2021 through July 2022. In total, 138,357 deliveries were recorded; 67,690 pre- and 70,667 post-implementations of SBBC. There were steady trends of increased 24-h newborn and maternal survival in four regions after SBBC initiation. In the first region, with 13 months of implementation (n = 15,658 deliveries), an estimated additional 100 newborns and 20 women were saved. Reported fresh stillbirths seemed to fluctuate across time, and increased in three regions after the start of SBBC. Uptake of the bundle varied between regions. This SBBC halfway evaluation indicates steady reductions in 24-h newborn and maternal mortality, in line with our hypotheses, in four of five regions. Enhanced focus on uptake of the bundle and the quality improvement component is necessary to fully reach the SBBC impact potential as we move forward.