Improvements in Obstetric and Newborn Health Information Documentation following the Implementation of the Safer Births Bundle of Care at 30 Facilities in Tanzania.

This paper examines changes in the completeness of documentation in clinical practice before and during the implementation of the Safer Births Bundle of Care (SBBC) project. This observational study enrolled parturient women with a gestation age of at least 28 weeks at the onset of labour. Data collectors extracted information from facility registers and then a central data manager summarised and reported weekly statistics. Variables of clinical significance for CQI were selected, and the proportion of non-documentation was analysed over time. A Pearson chi-square test was used to test for significant differences in non-documentation between the periods. Between 1 March 2021 and 31 July 2022, a total of 138,442 deliveries were recorded. Overall, 75% of all patient cases had at least one missing variable among the selected variables across both periods. A lack of variable documentation occurred more frequently at the district hospital level (81% of patient cases) and health centres (74%) than at regional referral hospitals (56%) (p < 0.001). Non-documentation decreased significantly from 79% to 70% after the introduction of the SBBC (p < 0.001). A tendency towards negative correlations was noted for most variables. We noted an increased attention to data quality and use which may have a positive impact on the completeness of documentation. However, halfway through the project's implementation, the completeness of documentation was still low. Our findings support the recommendation to establish short-spaced feedback loops of locally collected data using one data platform.

Increase in Newborns Ventilated Within the First Minute of Life and Reduced Mortality After Clinical Data-Guided Simulation Training.

INTRODUCTION: Birth asphyxia-related deaths is a major global concern. Rapid initiation of ventilation within the "Golden Minute" is important for intact survival but reported to be challenging, especially in low-/middle-income countries. Helping Babies Breathe (HBB) is a simulation-based training program for newborn resuscitation. The aim of this HBB quality improvement (QI) intervention was to decrease time from birth to ventilation and document potential changes in perinatal outcomes. METHOD: Prospective observational QI study in a rural Tanzanian hospital, October 1, 2017, to August 31, 2021, first-year baseline, second-year QI/simulation intervention, and 2-year postintervention. Trained research assistants observed wide-ranging information from all births (N = 12,938). The intervention included monthly targeted HBB simulation training addressing documented gaps in clinical care, clinical debriefings, and feedback meetings. RESULTS: During the QI/simulation intervention, 68.5% nonbreathing newborns were ventilated within 60 seconds after birth compared with 15.8% during baseline and 42.2% and 28.9% during the 2 postintervention years (P < 0.001). Time to first ventilation decreased from median 101 (quartiles 72-150) to 55 (45-67) seconds (P < 0.001), before increasing to 67 (49-97) and 85 (57-133) seconds after intervention. More nonbreathing newborns were ventilated in the intervention period (12.9%) compared with baseline (8.5%) and the postintervention years (10.6% and 9.4%) (P < 0.001). Assumed fresh stillborns decreased significantly from baseline to intervention (3.2%-0.7%) (P = 0.013). CONCLUSIONS: This QI study demonstrates an increase in nonbreathing newborns being ventilated within the Golden Minute and a significant reduction in fresh stillborns after introduction of an HBB QI/simulation intervention. Improvements are partially reversed after intervention, highlighting the need for continuous simulation-based training and research into QI efforts essential for sustainable changes.

Healthcare Workers' Perceptions on the "SaferBirths Bundle of Care": A Qualitative Study.

Background: SaferBirths Bundle of Care (SBBC) is a package of innovative clinical and training tools coupled with low-dose high-frequency simulation-based on-job training guided by local data. This bundle of care is a new initiative being implemented in 30 health facilities from five regions of Tanzania aiming at improving birth outcomes. Objective: To assess the perception of healthcare workers and facility leaders on the "SaferBirths Bundle of Care" towards saving women's and newborns' lives at birth. Method: We used a qualitative approach using focused group discussion (FGD) and individual interviews. A total of 21 FGD and 43 individual interviews were conducted between August and November 2022. In total, 94 midwives and 12 doctors were involved, some of whom were in leadership roles. The framework method for the analysis of qualitative data was used for analysis. Results: Healthcare workers and facility leaders received the bundle well and regarded it as effective in saving lives and improving healthcare provision. Five themes emerged as facilitators to the acceptance of the bundle: (1) the bundle is appropriate to our needs, (2) the training modality and data use fit our context, (3) use of champions and periodic mentorship, (4) learning from our mistakes, and (5) clinical and training tools are of high quality but can be further improved. Conclusion: The relevance of SaferBirths Bundle of Care in addressing maternal and perinatal deaths, the quality and modality of training, and the culture that enhances learning from mistakes were among the facilitators of the acceptability of the SBBC. A well-accepted intervention has huge potential for bringing the intended impact in health provision.

"Safer Births Bundle of Care" Implementation and Perinatal Impact at 30 Hospitals in Tanzania-Halfway Evaluation.

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.

Multiple micronutrients fortified salt: consumers' acceptability survey, Tanzania.

BACKGROUND: Food fortification with micronutrients is an insufficiently used technology in developing countries. Salt is consumed in small, constant daily amounts by most people globally. Salt has been instrumental in delivering iodine to a wide population globally through fortification. There is a proven effective technology for fortifying iodinated salt with iron, folate, and Vitamin B12. Findings have shown that both Double (Iodine and iron) fortified salt (DFS) and quadruple (iron, iodine, folate, and vitamin B12) fortified salt (QFS) are effective in raising hemoglobin levels. AIM: To assess the acceptability and gauge consumers' willingness to use double-fortified and quadruple-fortified salt formulations. METHODS: We conducted an observational study involving 300 households at Haydom Lutheran Hospital catchment area in Northern rural Tanzania between October 2021 and April 2022. Each household was supplied with one type of salt (iodized salt (IS), DFS or QFS) for cooking common family dishes for one week. Thereafter, at least two adult members of the family who used the dishes cooked with study salt were interviewed using the adopted 5-point Hedonic scale. RESULTS: A total of 899 individuals were interviewed after using study salt for one week: 286 IS, 305 DFS, and 308 QFS. The overall acceptability for the salts was QFS (82%), DFS (78%), and IS (79%). The mean sensory (taste, color and appearance) scores of the QFS (1.7) and DFS (1.7) were comparable to standard iodized salt (1.6). CONCLUSION: Quadruple-fortified salt and double-fortified salt are equally acceptable and have similar sensory scores as standard iodized salt when used to cook commonly eaten dishes in the study population.

Assessment of contextual factors shaping delivery and uptake of isoniazid preventive therapy among people living with HIV in Dar es salaam, Tanzania.

BACKGROUND: Tuberculosis has remained a leading cause of death among people living with HIV (PLHIV) globally. Isoniazid preventive therapy (IPT) is the recommended strategy by the World Health Organization to prevent TB disease and related deaths among PLHIV. However, delivery and uptake of IPT has remained suboptimal particularly in countries where HIV and TB are endemic such as Tanzania. This study sought to assess contextual factors that shape delivery and uptake of IPT in Dar es Salaam region, Tanzania. METHODOLOGY: We employed a qualitative case study design comprising of in-depth interviews with people living with HIV (n = 17), as well as key informant interviews with clinicians (n = 7) and health administrators (n = 7). We used thematic data analysis approach and reporting of the results was guided by the Consolidated Framework for Implementation Research (CFIR). RESULTS: Characteristics of IPT such as aligning the therapy to individual patient schedules and its relatively low cost facilitated its delivery and uptake. On the contrary, perceived adverse side effects negatively affected the delivery and uptake of IPT. Characteristics of individuals delivering the therapy including their knowledge, good attitudes, and commitment to meeting set targets facilitated the delivery and uptake of IPT. The process of IPT delivery comprised collective planning and collaboration among various facilities which facilitated its delivery and uptake. Organisational characteristics including communication among units and supportive leadership facilitated the delivery and uptake of IPT. External system factors including HIV stigma, negative cultural and religious values, limited funding as well as shortage of skilled healthcare workers presented as barriers to the delivery and uptake of IPT. CONCLUSION: The factors influencing the delivery and uptake of IPT among people living with HIV are multifaceted and exist at different levels of the health system. Therefore, it is imperative that IPT program implementers and policy makers adopt multilevel approaches that address the identified barriers and leverage the facilitators in delivery and uptake of IPT at both community and health system levels.

Newborn resuscitation simulation training and changes in clinical performance and perinatal outcomes: a clinical observational study of 10,481 births.

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.

Women's preferences for antenatal care in Tanzania: a discrete choice experiment.

BACKGROUND: The stillbirth rate in Tanzania remains high. Greater engagement with antenatal care may help to reduce stillbirths. We investigated which characteristics of antenatal care clinics are preferred by pregnant women in Tanzania. METHODS: We conducted an unlabelled discrete choice experiment (DCE) with think-aloud interviews. Participants were pregnant women, regardless of parity/gestation, from the Mwanza and Manyara regions of Tanzania. We asked participants to choose which of two hypothetical antenatal clinics they would rather attend. Clinics were described in terms of transport mode, cleanliness, comfort, visit content, and staff attitude. Each participant made 12 choices during the experiment, and a purposively selected sub-set simultaneously verbalised the rationale for their choices. We analysed DCE responses using a multinomial logit model adjusted for study region, and think-aloud data using the Framework approach. RESULTS: We recruited 251 participants split evenly between the 2 geographical regions. Staff attitude was the most important attribute in clinic choice and dominated the think-aloud narratives. Other significant attributes were mode of transport (walking was preferred) and content of clinic visit (preference was stronger with each additional element of care provided). Cleanliness of the clinic was not a significant attribute overall and the think-aloud exercise identified a willingness to trade-off cleanliness and comfort for respectful care. CONCLUSION: Women would prefer to attend a clinic with kind staff which they can access easily. This study suggests that exploration of barriers to providing respectful care, and enabling staff to deliver it, are important areas for future investment. The DCE shows us what average preferences are; antenatal care that is aligned with identified preferences should increase uptake and engagement versus care which does not acknowledge them.

Beyond research: improved perinatal care through scale-up of a Moyo fetal heart rate monitor coupled with simulation training in northern Tanzania for helping babies breathe.

BACKGROUND: The purpose of this project was to improve perinatal survival by introducing Moyo Fetal Heart Rate (FHR) Monitor coupled with neonatal resuscitation simulation training. METHODS: The implementation was done at three district hospitals. We assessed health care workers' (HCW's) skills and perinatal death trends during implementation. Baseline data were collected from the hospitals before implementation. Newborn resuscitation (NR) skills were assessed before and after simulation training. Assessment of perinatal outcomes was done over 2 years of implementation. We used descriptive analysis; a t-test (paired and independent two-sample) and a one-way Anova test to report the findings. RESULTS: A total of 107 HCW's were trained on FHR monitoring using Moyo and NR knowledge and skills using NeoNatalie simulators. The knowledge increased post-training by 13.6% (p <  0.001). Skills score was increased by 25.5 and 38.2% for OSCE A and B respectively (p <  0.001). The overall fresh stillbirths rate dropped from 9 to 5 deaths per 1000 total births and early neonatal deaths at 7 days from 5 to 3 (p <  0.05) deaths per 1000 live births over 2 years of implementation. CONCLUSION: There was a significant improvement of newborn resuscitation skills among HCW's and neonatal survival at 2 years. Newborn resuscitation training coupling with Moyo FHR monitor has shown potential for improving perinatal survival. However, further evaluation is needed to explore the full potential of the package.

Perinatal mortality audit in a rural referral hospital in Tanzania to inform future interventions: A descriptive study.

BACKGROUND: Clear evidence exists that perinatal audit and feedback can lead to important improvements in practice. The death audit can lead to the identification of existing potential delays which are the decision to seek medical care, reaching an appropriate facility, and receiving timely adequate care at the facility. Such an audit potentially initiates a positive discussion, which may foster the implementation of changes that aims at saving more lives. OBJECTIVE: To review the perinatal deaths case notes and identify potential gaps in care provision and health-seeking behavior to foster best practice. METHODS: The stillbirths and neonatal death case notes that occurred between January 2019 and May 2020 at the hospital were reviewed using an adapted WHO checklist. The completed review case notes were entered into an electronic system and a quality control check-up was done. Data were analysed descriptively, and findings were presented in tables. RESULTS: There were 4,898 births, and 1,175 neonatal admissions, out of these there were 135 recorded stillbirths (2.8%) and 201(4.1% of the total hospital births) early neonatal deaths. Out of the 1,175 neonates, 635 (54%) were born within the hospital and 540 (46%) were admitted from other facilities and home deliveries. In total 86 stillbirths and 140 early neonatal deaths case notes were retrieved and audited. Out of 86 stillbirths' case notes audited, 30 (34.9%) seemed to have died during labor, and of these 5 had audible fetal heart rate during admission. Apgar scores less than 7 at 5 minutes, prematurity, and meconium aspiration were the top three recorded causes of neonatal deaths. Inadequate/late antenatal care visits and home delivery were the maternal factors likely to have contributed to perinatal deaths. Inadequate labor monitoring (12%) and documentation (62%) were among the providers' factors likely to have contributed to perinatal deaths. CONCLUSION: This audit shows that there are high rates of preventable intrapartum stillbirths and early neonatal deaths. Both women and providers' factors were found to have contributed to the stillbirths and neonatal deaths. There is a need to encourage women to adequately attend antenatal care, utilize health facilities during birth, and improve maternity and neonatal care at the health facilities.

Etiology of severe invasive infections in young infants in rural settings in sub-Saharan Africa.

BACKGROUND: Serious invasive infections in newborns are a major cause of death. Lack of data on etiological causes hampers progress towards reduction of mortality. This study aimed to identify pathogens responsible for such infections in young infants in sub-Saharan Africa and to describe their antibiotics resistance profile. METHODS: Between September 2016 and April 2018 we implemented an observational study in two rural sites in Burkina Faso and Tanzania enrolling young infants aged 0-59 days old with serious invasive infection. Blood samples underwent blood culture and molecular biology. RESULTS: In total 634 infants with clinical diagnosis of serious invasive infection were enrolled and 4.2% of the infants had a positive blood culture. The most frequent pathogens identified by blood culture were Klebsiella pneumonia and Staphylococcus aureus, followed by Escherichia coli. Gram-negative isolates were only partially susceptible to first line WHO recommended treatment for neonatal sepsis at community level. A total of 18.6% of the infants were PCR positive for at least one pathogen and Escherichia coli and Staphylococcus aureus were the most common bacteria detected. Among infants enrolled, 60/634 (9.5%) died. Positive blood culture but not positive PCR was associated with risk of death. For most deaths, no pathogen was identified either by blood culture or molecular testing, and hence a causal agent remained unclear. Mortality was associated with low body temperature, tachycardia, respiratory symptoms, convulsions, history of difficult feeding, movement only when stimulated or reduced level of consciousness, diarrhea and/or vomiting. CONCLUSION: While Klebsiella pneumonia and Staphylococcus aureus, as well as Escherichia coli were pathogens most frequently identified in infants with clinical suspicion of serious invasive infections, most cases remain without definite diagnosis, making more accurate diagnostic tools urgently needed. Antibiotics resistance to first line antibiotics is an increasing challenge even in rural Africa.

Neonatal Resuscitation Skill-Training Using a New Neonatal Simulator, Facilitated by Local Motivators: Two-Year Prospective Observational Study of 9000 Trainings.

Globally, intrapartum-related complications account for approximately 2 million perinatal deaths annually. Adequate skills in neonatal resuscitation are required to reduce perinatal mortality. NeoNatalie Live is a newborn simulator providing immediate feedback, originally designed to accomplish Helping Babies Breathe training in low-resource settings. The objectives of this study were to describe changes in staff participation, skill-training frequency, and simulated ventilation quality before and after the introduction of "local motivators" in a rural Tanzanian hospital with 4000-5000 deliveries annually. Midwives (n = 15-27) were encouraged to perform in situ low-dose high-frequency simulation skill-training using NeoNatalie Live from September 2016 through to August 2018. Frequency and quality of trainings were automatically recorded in the simulator. The number of skill-trainings increased from 688 (12 months) to 8451 (11 months) after the introduction of local motivators in October 2017. Staff participation increased from 43% to 74% of the midwives. The quality of training performance, measured as "well done" feedback, increased from 75% to 91%. We conclude that training frequency, participation, and performance increased after introduction of dedicated motivators. In addition, the immediate constructive feedback features of the simulator may have influenced motivation and training quality performance.

SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania.

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.

Lay and healthcare providers' experiences to inform future of respectful maternal and newborn care in Tanzania and Malawi: an Appreciative Inquiry.

OBJECTIVES: Disrespectful care, which remains prevalent in low and middle-income countries (LMICs), acts as a barrier to women accessing skilled birth attendance, compromising care when services are available. Building on what was positive in facilities, we aimed to explore lay and healthcare providers' experience of respectful care to inform future interventions. SETTING: Five maternity facilities in Mwanza Tanzania and Lilongwe Malawi. PARTICIPANTS: 94 participants in Malawi (N=46) and Tanzania (N=48) including 24 women birthing live baby within the previous 12 months; 22 family members and 48 healthcare providers who regularly provided maternity care in the included facilities DESIGN: The study was guided by Appreciative Inquiry (AI). Semistructured, one-to-one interviews were conducted between January and December 2019. Interviews were audio-recorded, translated where necessary, transcribed verbatim, and analysed using the framework approach. RESULTS: Four main themes describing participants positive experience and their vision of respectful care were identified: (1) empathic healthcare provider-woman interactions including friendly welcome and courteous language, well-timed appropriate care and information sharing, (2) an enabling environment, characterised by improvement of physical environment, the use of screens, curtains and wall partitions for privacy, availability of equipment and provision of incentives to staff, (3) supportive leadership demonstrated by the commitment of the government and facility leaders to provision of respectful care, ensuring availability of guidelines and policies, supportive supervision, reflective discussion and paying staff salaries timely, (4) providers' attitudes and behaviours characterised by professional values through readiness, compassionate communication and commitment. CONCLUSION: The positive experiences of service users, families and healthcare providers provided insight into key drivers of respectful care in facilities in Tanzania and Malawi. Interventions targeting improved environment and privacy, healthcare provider communication and developing positive leadership structures in facilities could provide the basis for sustained improvement in respectful and dignified maternal and newborn care in LMICs.

Effect of scheduled antimicrobial and nicotinamide treatment on linear growth in children in rural Tanzania: A factorial randomized, double-blind, placebo-controlled trial.

BACKGROUND: Stunting among children in low-resource settings is associated with enteric pathogen carriage and micronutrient deficiencies. Our goal was to test whether administration of scheduled antimicrobials and daily nicotinamide improved linear growth in a region with a high prevalence of stunting and enteric pathogen carriage. METHODS AND FINDINGS: We performed a randomized, 2 × 2 factorial, double-blind, placebo-controlled trial in the area around Haydom, Tanzania. Mother-child dyads were enrolled by age 14 days and followed with monthly home visits and every 3-month anthropometry assessments through 18 months. Those randomized to the antimicrobial arm received 2 medications (versus corresponding placebos): azithromycin (single dose of 20 mg/kg) at months 6, 9, 12, and 15 and nitazoxanide (3-day course of 100 mg twice daily) at months 12 and 15. Those randomized to nicotinamide arm received daily nicotinamide to the mother (250 mg pills months 0 to 6) and to the child (100 mg sachets months 6 to 18). Primary outcome was length-for-age z-score (LAZ) at 18 months in the modified intention-to-treat group. Between September 5, 2017 and August 31, 2018, 1,188 children were randomized, of whom 1,084 (n = 277 placebo/placebo, 273 antimicrobial/placebo, 274 placebo/nicotinamide, and 260 antimicrobial/nicotinamide) were included in the modified intention-to-treat analysis. The study was suspended for a 3-month period by the Tanzanian National Institute for Medical Research (NIMR) because of concerns related to the timing of laboratory testing and the total number of serious adverse events (SAEs); this resulted in some participants receiving their final study assessment late. There was a high prevalence of stunting overall (533/1,084, 49.2%). Mean 18-month LAZ did not differ between groups for either intervention (mean LAZ with 95% confidence interval [CI]: antimicrobial: -2.05 CI -2.13, -1.96, placebo: -2.05 CI -2.14, -1.97; mean difference: 0.01 CI -0.13, 0.11, p = 0.91; nicotinamide: -2.06 CI -2.13, -1.95, placebo: -2.04 CI -2.14, -1.98, mean difference 0.03 CI -0.15, 0.09, p = 0.66). There was no difference in LAZ for either intervention after adjusting for possible confounders (baseline LAZ, age in days at 18-month measurement, ward, hospital birth, birth month, years of maternal education, socioeconomic status (SES) quartile category, sex, whether the mother was a member of the Datoga tribe, and mother's height). Adverse events (AEs) and SAEs were overall similar between treatment groups for both the nicotinamide and antimicrobial interventions. Key limitations include the absence of laboratory measures of pathogen carriage and nicotinamide metabolism to provide context for the negative findings. CONCLUSIONS: In this study, we observed that neither scheduled administration of azithromycin and nitazoxanide nor daily provision of nicotinamide was associated with improved growth in this resource-poor setting with a high force of enteric infections. Further research remains critical to identify interventions toward improved early childhood growth in challenging conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03268902.

Fetal heart rate development during labour.

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 ([Formula: see text]) using Wilcoxon signed-rank test. A drop in median FHR as well as an increased spread in FHR is observed for all defined outcome groups in the same interval. CONCLUSION: A significant drop in FHR the last 150 min before birth is seen for all neonates with a normal outcome or still admitted to the NCU at 24 h after birth. The observed earlier and larger drop in the perinatal mortality group may indicate that they struggle to endure the physical strain of labour, and that an earlier intervention could potentially save lives. Due to the low amount of data in the perinatal mortality group, a larger dataset is required to validate the drop for this group.

The impact of introducing ambulance and delivery fees in a rural hospital in Tanzania.

BACKGROUND: Access to health care facilities is a key requirement to enhance safety for mothers and newborns during labour and delivery. Haydom Lutheran Hospital (HLH) is a regional hospital in rural Tanzania with a catchment area of about two million inhabitants. Up to June 2013 ambulance transport and delivery at HLH were free of charge, while a user fee for both services was introduced from January 2014. We aimed to explore the impact of introducing user fees on the population of women giving birth at HLH in order to document potentially unwanted consequences in the period after introduction of fees. METHODS: Retrospective analysis of data from a prospective observational study. Data was compared between the period before introduction of fees from February 2010 through June 2013 and the period after from January 2014 through January 2017. Logistic regression modelling was used to construct risk-adjusted variable-life adjusted display (VLAD) and cumulative sum (CUSUM) plots to monitor changes. RESULTS: A total of 28,601 births were observed. The monthly number of births was reduced by 17.3% during the post-introduction period. Spontaneous vaginal deliveries were registered less frequently with a decrease of about 17/1000 births in non-cephalic presentations. Labour complications and caesarean sections increased with about 80/1000 births. There was a reduction in newborns with birth weight less than 2500 g. The observed changes were stable over time. For most variables, a significant change could be detected after a few weeks. CONCLUSION: After the introduction of ambulance and delivery fees, an increase in labour complications and caesarean sections and a decrease in newborns with low birthweight were observed. This might indicate that women delay the decision to seek skilled birth attendance or do not seek help at all, possibly due to financial reasons. Lower rates of births in a safe health care facility like HLH is of great concern, as access to skilled birth attendance is a key requirement in order to further reduce perinatal mortality. Therefore, free delivery care should be a high priority.

Increased perinatal survival and improved ventilation skills over a five-year period: An observational study.

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.

Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.

Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z-score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.

Midwives' and Women's Perception on Moyo Fetal Heart Rate Monitor for Intrapartum Fetal Heart Rate Monitoring; A Cross-Sectional Study.

BACKGROUND: The annual global neonatal mortality stands at 2.5 million deaths, 1 million of them dying within the first day of life. An additional 2.6 million are stillborn globally, the majority of them due to intrapartum events. Optimal fetal heart rate (FHR) monitoring has the potential to timely detect fetuses at risk and, if coupled with timely obstetric responses may save more newborns. Moyo is a new Doppler with nine crystals capable of monitoring FHR both intermittently and continuously. AIM: To assess women's and midwives' opinions on the use of Moyo for intrapartum FHR monitoring. METHODS: We conducted a cross-sectional study using a structured questionnaire to assess women's and midwives' perception. Women who gave birth at the hospital who used Moyo were interviewed using a questionnaire immediately before discharge from the hospital. Twenty-eight midwives who have been using Moyo for more than 6 months were also interviewed using a structured questionnaire. Data were analyzed using excel and result presented in figures. RESULTS: In total 113 postpartum women who were monitored using Moyo were interviewed before discharge. Out of these, 46 (40.7%) were first-time mothers and the rest were multipara. In total, 95 women (84.1%) used Moyo and other devices for FHR monitoring, 81 (72%) said Moyo was better than Fetoscopes and handheld Doppler, two-third 75 (66.4%) felt that Moyo was comfortable and 93 (82.3%) would like Moyo to be used on them in the future. Out of 28 midwives, 11 (39.3%) used Moyo continuous only, 3 (10.7%) used Moyo intermittently only and 14 (50.0%) used both intermittent and continuous. Thirteen (46.4%) midwives prefer to use Moyo both intermittent and continuous. Sixteen (55.6%) said Moyo was effective, 21 (75%) felt comfortable to use Moyo, and 13 (46.4%) said Moyo was easy to use. CONCLUSION: The majority of midwives and women who used Moyo felt that Moyo was comfortable for intrapartum FHR monitoring. Moyo can be used both intermittently and continuously depending on the user's preferences.