Improved obstetric management after implementation of a scaled-up quality improvement intervention: A nested before-after study in three public hospitals in Nepal.

BACKGROUND: We assessed the change in obstetric management after implementation of a quality improvement intervention, the Nepal Perinatal Quality Improvement Package (NePeriQIP). METHODS: The Nepal Perinatal Quality Improvement Package was a stepped-wedge cluster-randomized controlled trial conducted in 12 public hospitals in Nepal between April 2017 and October 2018. In this study, three hospitals allocated at different time points to the intervention were selected for a nested before-after analysis. We used bivariate and multivariate analyses to compare obstetric management in the control vs intervention group. RESULTS: There were 25 977 deliveries in the three hospitals during the study period: 10 207 (39%) in the control and 15 770 (61%) in the intervention group. After adjusting for maternal age, ethnicity, education, gestational age, stage of labor at admission, complications during labor, and birthweight, the intervention group had a higher proportion of fetal heart rate monitoring performed as per protocol (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12-1.27), shorter time intervals between each fetal heart rate monitoring (aOR 2.09, 95% CI 1.96-2.23), a higher likelihood of abnormal fetal heart rate being detected (aOR 1.53, 95% CI 1.25-1.68), progress of labor more often being recorded immediately after per vaginal examination (aOR 2.73, 95% CI 2.55-2.93), and partograph filled as per standards (aOR 3.18, 95% CI 2.98-3.50). The cesarean birth rate was 2.5% in the control group and 8.2% in the intervention group (aOR 3.12, 95% CI 2.64-3.68). CONCLUSIONS: The NePeriQIP intervention has potential to improve obstetric care, especially intrapartum fetal surveillance, in similar low-resource settings.

Burden and consequence of birth defects in Nepal-evidence from prospective cohort study.

BACKGROUND: Every year an estimated 7.9 million babies are born with birth defect. Of these babies, more than 3 million die and 3.2 million have disability. Improving nationwide information on prevalence of birth defect, risk factor and consequence is required for better resource allocation for prevention, management and rehabilitation. In this study, we assess the prevalence of birth defect, associated risk factors and consequences in Nepal. METHOD: This is a prospective cohort study conducted in 12 hospitals of Nepal for 18 months. All the women who delivered in the hospitals during the study period was enrolled. Independent researchers collected data on the social and demographic information using semi-structured questionnaire at the time of discharge and clinical events and birth outcome information from the clinical case note. Data were analyzed on the prevalence and type of birth defect. Logistic regression was done to assess the risk factor and consequences for birth defect. RESULTS: Among the total 87,242 livebirths, the prevalence of birth defects was found to be 5.8 per 1000 live births. The commonly occurring birth defects were anencephaly (3.95%), cleft lip (2.77%), cleft lip and palate (6.13%), clubfeet (3.95%), eye abnormalities (3.95%) and meningomyelocele (3.36%). The odds of birth defect was higher among mothers with age < 20 years (adjusted Odds ratio (aOR) 1.64; 95% CI, 1.18-2.28) and disadvantaged ethnicity (aOR 1.78; 95% CI, 1.46-2.18). The odds of birth asphyxia was twice fold higher among babies with birth defect (aOR 1.88; 95% CI, 1.41-2.51) in reference with babies without birth defect. The odds of neonatal infection was twice fold higher among babies with birth defect (aOR 1.82; 95% CI, 1.12-2.96) in reference with babies without birth defect. Babies with birth defect had three-fold risk of pre-discharge mortality (aOR 3.00; 95% CI, 1.93-4.69). CONCLUSION: Maternal age younger than 20 years and advantaged ethnicity were risk factors of birth defects. Babies with birth defect have high risk for birth asphyxia, neonatal infection and pre-discharge mortality at birth. Further evaluation on the care provided to babies who have birth defect is warranted. FUNDING: Swedish Research Council (VR).

REFINE (Rapid Feedback for quality Improvement in Neonatal rEsuscitation): an observational study of neonatal resuscitation training and practice in a tertiary hospital in Nepal.

BACKGROUND: Simulation-based training in neonatal resuscitation is more effective when reinforced by both practice and continuous improvement processes. We aim to evaluate the effectiveness of a quality improvement program combined with an innovative provider feedback device on neonatal resuscitation practice and outcomes in a public referral hospital of Nepal. METHODS: A pre- and post-intervention study will be implemented in Pokhara Academy of Health Sciences, a hospital with 8610 deliveries per year. The intervention package will include simulation-based training (Helping Babies Breathe) enhanced with a real-time feedback system (the NeoBeat newborn heart rate meter with the NeoNatalie Live manikin and upright newborn bag-mask with PEEP) accompanied by a quality improvement process. An independent research team will collect perinatal data and conduct stakeholder interviews. DISCUSSION: This study will provide further information on the efficiency of neonatal resuscitation training and implementation in the context of new technologies and quality improvement processes. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN18148368 , date of registration-31 July 2018.

Incidence, risk factors and consequences of preterm birth - findings from a multi-centric observational study for 14 months in Nepal.

BACKGROUND: Preterm birth is a worldwide epidemic and a leading cause of neonatal mortality. In this study, we aimed to evaluate the incidence, risk factors and consequences of preterm birth in Nepal. METHODS: This was an observational study conducted in 12 public hospitals of Nepal. All the babies born during the study period were included in the study. Babies born < 37 weeks of gestation were classified as preterm births. For the association and outcomes for preterm birth, univariate followed by multiple regression analysis was conducted. RESULTS: The incidence of preterm was found to be 93 per 1000 live births. Mothers aged less than 20 years (aOR 1.26;1.15-1.39) had a high risk for preterm birth. Similarly, education of the mother was a significant predictor for preterm birth: illiterate mothers (aOR 1.41; 1.22-1.64), literate mothers (aOR 1.21; 1.08-1.35) and mothers having basic level of education (aOR 1.17; 1.07-1.27). Socio-demographic factors such as smoking (aOR 1.13; 1.01-1.26), use of polluted fuel (aOR 1.26; 1.17-1.35) and sex of baby (aOR 1.18; 1.11-1.26); obstetric factors such as nulliparity (aOR 1.33; 1.20-1.48), multiple delivery (aOR 6.63; 5.16-8.52), severe anemia during pregnancy (aOR 3.27; 2.21-4.84), antenatal visit during second trimester (aOR 1.13; 1.05-1.22) and third trimester (aOR 1.24; 1.12-1.38), < 4 antenatal visits during pregnancy (aOR 1.49; 1.38-1.61) were found to be significant risk factors of preterm birth. Preterm has a risk for pre-discharge mortality (10.60; 9.28-12.10). CONCLUSION: In this study, we found high incidence of preterm birth. Various socio-demographic, obstetric and neonatal risk factors were associated with preterm birth. Risk factor modifications and timely interventions will help in the reduction of preterm births and associated mortalities. TRIAL REGISTRATION: ISRCTN30829654.

Not Crying After Birth as a Predictor of Not Breathing.

BACKGROUND: Worldwide, every year, 6 to 10 million infants require resuscitation at birth according to estimates based on limited data regarding "nonbreathing" infants. In this article, we aim to describe the incidence of "noncrying" and nonbreathing infants after birth, the need for basic resuscitation with bag-and-mask ventilation, and death before discharge. METHODS: We conducted an observational study of 19 977 infants in 4 hospitals in Nepal. We analyzed the incidence of noncrying or nonbreathing infants after birth. The sensitivity of noncrying infants with nonbreathing after birth was analyzed, and the risk of predischarge mortality between the 2 groups was calculated. RESULTS: The incidence of noncrying infants immediately after birth was 11.1%, and the incidence of noncrying and nonbreathing infants was 5.2%. Noncrying after birth had 100% sensitivity for nonbreathing infants after birth. Among the "noncrying but breathing" infants, 9.5% of infants did not breathe at 1 minute and 2% did not to breathe at 5 minutes. Noncrying but breathing infants after birth had almost 12-fold odds of predischarge mortality (adjusted odds ratio 12.3; 95% confidence interval, 5.8-26.1). CONCLUSIONS: All nonbreathing infants after birth do not cry at birth. A proportion of noncrying but breathing infants at birth are not breathing by 1 and 5 minutes and have a risk for predischarge mortality. With this study, we provide evidence of an association between noncrying and nonbreathing. This study revealed that noncrying but breathing infants require additional care. We suggest noncrying as a clinical sign for initiating resuscitation and a possible denominator for measuring coverage of resuscitation.

Prevalence, risk factors and consequences of newborns born small for gestational age: a multisite study in Nepal.

OBJECTIVE: To identify the prevalence, risk factors and health impacts associated with small for gestational age (SGA) births in Nepal. METHODS: A cross-sectional study was conducted in 12 public hospitals in Nepal from 1 July 2017 to 29 August 2018. A total of 60 695 babies delivered in these hospitals during the study period were eligible for inclusion. Clinical information of mothers and newborns was collected by data collectors using a data retrieval form. A semistructured interview was conducted at the time of discharge to gather sociodemographic information from women who provided the consent (n=50 392). Babies weighing less than the 10th percentile for their gestational age were classified as SGA. Demographic, obstetric and neonatal characteristics of study participants were analysed for associations with SGA. The association between SGA and likelihood of babies requiring resuscitation or resulting in stillbirth and neonatal death was also explored. RESULTS: The prevalence of SGA births across the 12 hospitals observed in Nepal was 11.9%. After multiple variable adjustment, several factors were found to be associated with SGA births, including whether mothers were illiterate compared with those completing secondary and higher education (adjusted OR (AOR)=1.73; 95% CI 1.09 to 2.76), use of polluted fuel compared with use of clean fuel for cooking (AOR=1.51; 95% CI 1.16 to 1.97), first antenatal care (ANC) visit occurring during the third trimester compared with first trimester (AOR=1.82; 95% CI 1.27 to 2.61) and multiple deliveries compared with single delivery (AOR=3.07; 95% CI 1.46 to 6.46). SGA was significantly associated with stillbirth (AOR=7.30; 95% CI 6.26 to 8.52) and neonatal mortality (AOR=5.34; 95% CI 4.65 to 6.12). CONCLUSIONS: Low literacy status of mothers, use of polluted fuel for cooking, time of first ANC visit and multiple deliveries are associated with SGA births. Interventions encouraging pregnant women to attend ANC visits early can reduce the burden of SGA births.

Out of Pocket Expenditure for Sick Newborn Care in Referral Hospitals of Nepal.

BACKGROUND: Almost all preventable neonatal deaths take place in low- and middle-income countries and affect the poorest who have the least access to high quality health services. Cost of health care is one of the factors preventing access to quality health services and universal health coverage. In Nepal, the majority of expenses related to newborn care are borne by the caregiver, regardless of socioeconomic status. We conducted a study to assess the out of pocket expenditure (OOPE) for sick newborn care in hospitals in Nepal. METHODS: This cross-sectional study of hospital care for newborns was conducted in 11 hospitals in Nepal and explored OOPE incurred by caregivers for sick newborn care. Data were collected from the caregivers of the sick newborn on the topics of cost of travel, accommodation, treatment (drugs, diagnosis) and documented on a sick newborn case record form. RESULTS: Data were collected from 814 caregivers. Cost of caregivers' stay accounted for more than 40% of the OOPE for sick newborn care, followed by cost of travel, and the baby's stay and treatment. The overall OOPE ranged from 13.6 to 226.1 US dollars (USD). The median OOPE was highest for preterm complications ($33.2 USD; CI 14.0-226.1), followed by hyperbilirubinemia ($31.9 USD; CI 14.0-60.7), respiratory distress syndrome ($26.9 USD; 15.3-121.5), neonatal sepsis ($ 25.8 USD; CI 13.6-139.8) and hypoxic ischemic encephalopathy ($23.4 USD; CI 13.6-97.7). DISCUSSION FOR PRACTICE: In Nepal, OOPE for sick newborn care in hospitals varied by neonatal morbidity and duration of stay. The largest proportion of OOPE were for accommodation and travel. Affordable and accessible health care will substantially reduce the OOPE for sick newborn care in hospitals.

Meconium aspiration syndrome: incidence, associated risk factors and outcome-evidence from a multicentric study in low-resource settings in Nepal.

AIM: The aim of this study was to identify the incidence, risk factors and outcome associated with meconium aspiration syndrome (MAS). METHODS: An observational study was conducted in 12 public hospitals in Nepal from 1 July 2017 to 29 August 2018. All babies born within the study period were included in the study. Babies who were diagnosed as MAS were designated as outcome. Data were analysed with bivariate analysis followed by multiple regression analysis. RESULTS: The overall incidence of MAS was 2.0 per 1000 livebirths. Babies born at post-term gestation (adjusted odds ratio (AOR) = 2.41; 95% confidence interval (CI): 1.05-5.55), nulliparity (AOR = 2.26; 95% CI: 1.20-4.28), instrumental delivery (AOR = 4.79; 95% CI: 2.52-9.10) and caesarean delivery (AOR = 3.67; 95% CI: 2.29-5.89) were significantly associated with MAS. Babies with MAS had a 10-fold risk for pre-discharge mortality (odds ratio = 9.87; 95% CI: 5.81-16.76). CONCLUSIONS: The findings in this study are consistent with that reported in other studies. MAS has a high risk of neonatal mortality. Thus, monitoring during pregnancy and labour is necessary for early identification of high-risk conditions associated with MAS. Strengthening of newborn care services is essential to curtail mortality.

Trends for Neonatal Deaths in Nepal (2001-2016) to Project Progress Towards the SDG Target in 2030, and Risk Factor Analyses to Focus Action.

INTRODUCTION: Nepal has made considerable progress on improving child survival during the Millennium Development Goal period, however, further progress will require accelerated reduction in neonatal mortality. Neonatal survival is one of the priorities for Sustainable Development Goals 2030. This paper examines the trends, equity gaps and factors associated with neonatal mortality between 2001 and 2016 to assess the likelihood of Every Newborn Action Plan (ENAP) target being reached in Nepal by 2030. METHODS: This study used data from the 2001, 2006, 2011 and 2016 Nepal Demographic and Health Surveys. We examined neonatal mortality rate (NMR) across the socioeconomic strata and the annual rate of reduction (ARR) between 2001 and 2016. We assessed association of socio-demographic, maternal, obstetric and neonatal factors associated with neonatal mortality. Based on the ARR among the wealth quintile between 2001 and 2016, we made projection of NMR to achieve the ENAP target. Using the Lorenz curve, we calculated the inequity distribution among the wealth quintiles between 2001 and 2016. RESULTS: In NDHS of 2001, 2006, 2011 and 2016, a total of 8400, 8600, 13,485 and 13,089 women were interviewed respectively. There were significant disparities between wealth quintiles that widened over the 15 years. The ARR for NMR declined with an average of 4.0% between 2001 and 2016. Multivariate analysis of the 2016 data showed that women who had not been vaccinated against tetanus had the highest risk of neonatal mortality (adjusted odds ratio [AOR] 3.38; 95% confidence interval [CI] 1.20-9.55), followed by women who had no education (AOR 1.87; 95% CI 1.62-2.16). Further factors significantly associated with neonatal mortality were the mother giving birth before the age of 20 (AOR 1.76; CI 95% 1.17-2.59), household air pollution (AOR 1.37; CI 95% 1.59-1.62), belonging to a poorest quintile (AOR 1.37; CI 95% 1.21-1.54), residing in a rural area (AOR 1.28; CI 95% 1.13-1.44), and having no toilet at home (AOR 1.21; CI 95% 1.06-1.40). If the trend of neonatal mortality rate of 2016 continues, it is projected that the poorest family will reach the ENAP target in 2067. CONCLUSIONS: Although neonatal mortality is declining in Nepal, if the current trend continues it will take another 50 years for families in the poorest group to attain the 2030 ENAP target. There are different factors associated with neonatal mortality, reducing the disparities for maternal and neonatal care will reduce mortality among the poorest families.

The Association of Women's Empowerment with Stillbirths in Nepal.

INTRODUCTION: Globally, 2.6 million stillbirths occur each year. Empowering women can improve their overall reproductive health and help reduce stillbirths. Women empowerment has been defined as women's ability to make choices in economic decision-making, household and health care decision-making. In this paper, we aimed to evaluate if women's empowerment is associated with stillbirths. METHODS: Data from 2016 Nepal Demographic Health Surveys (NDHS) were analysed to evaluate the association between women's empowerment and stillbirths. Equiplots were generated to assess the distribution of stillbirths by wealth quintile, place of residence and level of maternal education using data from NHDS 1996, 2001, 2006, 2011 and 2016 data. For the association of women empowerment factors and stillbirths, univariate and multivariate analyses were conducted. RESULTS: A total of 88 stillbirths were reported during the survey. Univariate analysis showed age of mother, education of mother, age of husband, wealth index, head of household, decision on healthcare and decision on household purchases had significant association with stillbirths (p < 0.05). In multivariate analysis, only maternal age 35 years and above was significant (aOR 2.42; 1.22-4.80). Education of mother (aOR 1.48; 0.94-2.33), age of husband (aOR 1.54; 0.86-2.76), household head (aOR 1.51; 0.88-2.59), poor wealth index (aOR 1.62; 0.98-2.68), middle wealth index (aOR 1.37; 0.76-2.47), decision making for healthcare (aOR 1.36; 0.84-2.21) and household purchases (aOR 1.01; 0.61-1.66) had no any significant association with stillbirths. CONCLUSIONS: There are various factors linked with stillbirths. It is important to track stillbirths to improve health outcomes of mothers and newborn. Further studies are necessary to analyse women empowerment factors to understand the linkages between empowerment and stillbirths.

Quality of Care for Maternal and Newborn Health in Health Facilities in Nepal.

INTRODUCTION: Nepal has pledged to substantially reduce maternal and newborn death by 2030. Improving quality of intrapartum health services will be vital to reduce these deaths. This paper examines quality of delivery and newborn services in health facilities of Nepal. METHODS: Data were sourced from the Nepal Health Facility Survey 2015, which covered a national representative sample of health facilities. The datasets were analysed to assess service readiness, availability and quality of delivery and newborn care in a sample of 992 health facilities. RESULTS: Of the 992 facilities in the sample, 623 provided delivery and newborn care services. Of the 623 facilities offering delivery and newborn care services, 13.3% offered comprehensive emergency obstetric care (CEmONC), 19.6% provided basic emergency obstetric care (BEmONC) and 53.9% provided basic delivery and newborn service. The availability of essential equipment for delivery and newborn care was more than 80% in health facilities. Except for the coverage of vitamin K injection, the coverage of immediate newborn care was more than 85% in all health facilities. The coverage of use of chlorhexidine ointment to all newborns was more than 70% in government hospitals and primary health care centers (PHCCs) and only 32.3% in private hospitals. CONCLUSIONS: These findings show gaps in equipment and drugs, especially in PHCCs and private health facilities. Improving readiness and availability of equipment and drugs in PHCCs and private health facility will help improve the quality of care to further reduce maternal and newborn mortality in Nepal.

Stunting Among Under 5-Year-Olds in Nepal: Trends and Risk Factors.

INTRODUCTION: The nutritional status in the first 5 years of life has lifelong and inter-generational impacts on individual's potential and development. This study described the trend of stunting and its risk factors in children under 5 years of age between 2001 and 2016 in Nepal. METHODS: The study used datasets from the 2001, 2006, 2011 and 2016 Nepal Demographic Health Surveys to describe the trend of stunting in under 5-year children. Multiple logistic regression analysis was carried out to assess the risk factors for stunting at the time of the four surveys. RESULTS: The nutritional status of under 5-year children improved between 2001 and 2016. Babies born into poorer families had a higher risk of stunting than those born into wealthier families (AOR 1.51, CI 95% 1.23-1.87). Families residing in hill districts had less risk of stunting than those in the Terai plains (AOR 0.75, CI 95% 0.61-0.94). Babies born to uneducated women had a higher risk of stunting than those born to educated women (AOR 1.57, CI 95% 1.28-1.92). DISCUSSION: Stunting among under-5-year children decreased in the years spanning 2001-2016. This study demonstrated multiple factors that can be addressed to decrease the risk of stunting, which has important implications for neurodevelopment later in life. We add literature on risk factors for stunting in under-5-year children.

Effect of skill drills on neonatal ventilation performance in a simulated setting- observation study in Nepal.

AIM: Maintaining neonatal resuscitation skills among health workers in low resource settings will require continuous quality improvement efforts. We aimed to evaluate the effect of skill drills and feedback on neonatal resuscitation and the optimal number of skill drills required to maintain the ventilation skill in a simulated setting. METHODS: An observational study was conducted for a period of 3 months in a referral hospital of Nepal. Sixty nursing staffs were trained on Helping Babies Breathe (HBB) 2.0 and daily skill drills using a high-fidelity manikin. The high-fidelity manikin had different clinical case scenarios and provided feedback as "well done" or "improvement required" based on the ventilation performance. Adequate ventilation was defined as bag-and-mask ventilation at the rate of 40-60 breaths per minute. The effective ventilation was defined as adequate ventilation with a "well done" feedback. We assessed the correlation of number skill drills and clinical case scenario with adequate ventilation rate using pearson's correlation. We assessed the correlation of number of skill dills performed by each participant with effective ventilation using Mann Whitney test. RESULTS: Among the total of 60 nursing staffs, all of them were competent with an average score of 12.73 ± 1.09 out of 14 (p < 0.001) on bag-and-mask ventilation skill checklist. Among the trained staff, 47 staffs participated in daily skill drills who performed a total of 331 skill drills and 68.9% of the ventilations were done adequately. Among the 47 nursing staffs who performed the skill drills, 228 (68.9%) drills were conducted at a ventilation rate of 40-60 breathes per minute. There was no correlation of the adequate ventilation with skill drill category (p = 0.88) and the level of skill performed (p = 0.28). Out of 47 participants performing the skill drills, 74.5% of them had done effective ventilation with a mean average of 8 skill drills (SD ± 4.78) (p-value- 0.032). CONCLUSION: In a simulated setting, participants who had an average skill drill of 8 in 3 months had effective ventilation. We demonstrated optimal skill drill sessions for maintain the neonatal resuscitation competency. Further evaluation will be required to validate the findings in a scale up setting.

Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial.

BACKGROUND: Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. METHODS AND FINDINGS: We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers' competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women-infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69-0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78-1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32-1.77, p = 0.003). There were two major limitations to the study; although a large sample of women-infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided. CONCLUSION: These results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care. TRIAL REGISTRATION: ISRCTN30829654.

Effectiveness and Acceptability of Bag-and-mask Ventilation with Visual Monitor for Improving Neonatal Resuscitation in Simulated Setting in Six Hospitals of Nepal.

BACKGROUND: Improving the performance of health workers on neonatal resuscitation will be critical to ensure that the babies are effectively ventilated. We conducted a study to evaluate whether a bag-and-mask ventilation with monitor is effective in improving neonatal resuscitation practice in a simulated setting. METHODS: This is a cross-over design conducted in 6 public hospitals with 82 health workers of Nepal nested over a large scale stepped wedged quality improvement project. A one-day training on neonatal resuscitation was conducted. At the end of the training, participants were evaluated on the bag-and-mask ventilation performance in a manikinbased on the tidal volume, positive end expiratory pressure and air leakage from the maskin two sessions (monitor displayed versus hidden). The comparison of the neonatal resuscitation performance with and without monitor displayed is calculated. We also conducted assessment of confidence with or without monitor of the health workers. RESULTS: Adequacy of ventilation using bag-and-mask was better when the health workers were displayed monitor (90%) vs without monitor (76%) (p<0.01). The air leakage from the mask reduced when the monitor was displayed (12%) vs without (30%). The PEEP improved when the health workers used monitor as guide to conduct neonatal resuscitation in the manikin then without monitor displayed. The participants felt more confident performing ventilations during the visible sessions. CONCLUSIONS: The ventilation function monitor helped participants to improve their ventilation skills through realtime feedback of important ventilation parameters. Clinical evaluation of needs to be done to assess the effectiveness of the device.

Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals.

BACKGROUND: Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package-Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)-on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. METHODS: We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. DISCUSSION: With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. TRIAL REGISTRATION NUMBER: ISRCTN16741720 . Registered on 2 March 2019.

Scaling up quality improvement intervention for perinatal care in Nepal (NePeriQIP); study protocol of a cluster randomised trial.

INTRODUCTION: Nepal Perinatal Quality Improvement Project (NePeriQIP) intends to scale up a quality improvement (QI) intervention for perinatal care according to WHO/National guidelines in hospitals of Nepal using the existing health system structures. The intervention builds on previous research on the implementation of Helping Babies Breathe-quality improvement cycle in a tertiary healthcare setting in Nepal. The objective of this study is to evaluate the effect of this scaled-up intervention on perinatal health outcomes. METHODS/DESIGN: Cluster-randomised controlled trial using a stepped wedged design with 3 months delay between wedges will be conducted in 12 public hospitals with a total annual delivery rate of 60 000. Each wedge will consist of 3 hospitals. Impact will be evaluated on intrapartum-related mortality (primary outcome), overall neonatal mortality and morbidity and health worker's performance on neonatal care (secondary outcomes). A process evaluation and a cost-effectiveness analysis will be performed to understand the functionality of the intervention and to further guide health system investments will also be performed. DISCUSSION: In contexts where resources are limited, there is a need to find scalable and sustainable implementation strategies for improved care delivery. The proposed study will add to the scarce evidence base on how to scale up interventions within existing health systems. If successful, the NePeriQIP model can provide a replicable solution in similar settings where support and investment from the health system is poor, and national governments have made a global pledge to reduce perinatal mortality. TRIAL REGISTRATION NUMBER: ISRCTN30829654.