Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain. METHODS: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life. RESULTS: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care. CONCLUSIONS: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

The Association Between Breastfeeding and Growth Among Infants with Moderately Low Birth Weight: A Prospective Cohort Study.

OBJECTIVE: To assess the association between breastfeeding competency, as determined by Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) and Preterm Infant Breastfeeding Behavior Scale (PIBBS) scores, and exclusive breastfeeding and growth among infants with low birth weight (LBW) in India, Malawi, and Tanzania. STUDY DESIGN: We conducted LATCH and PIBBS assessments among mother-infant dyads enrolled in the Low Birthweight Infant Feeding Exploration (LIFE) observational study of infants with moderately LBW (1500g-2499 g) in India, Malawi, and Tanzania. We analyzed feeding and growth patterns among this cohort. RESULTS: We observed 988 infants. We found no association between LATCH or PIBBS scores and rates of exclusive breastfeeding at 4 or 6 months. Higher week 1 LATCH and PIBBS scores were associated with increased likelihood of regaining birth weight by 2 weeks of age [LATCH: aRR 1.42 (95% CI 1.15, 1.76); PIBBS: aRR 1.15 (95% CI 1.07, 1.23); adjusted for maternal age, parity, education, residence, delivery mode, LBW type, number of offspring, and site]. Higher PIBBS scores at 1 week were associated with improved weight gain velocity (weight-for-age z-score change) at 1, 4, and 6 months [adjusted beta coefficient: 1 month 0.04 (95% CI 0.01, 0.06); 4 month 0.04 (95% CI 0.01, 0.06); and 6 month 0.04 (95% CI 0.00, 0.08)]. CONCLUSION: Although week 1 LATCH and PIBBS scores were not associated with rates of exclusive breastfeeding, higher scores were positively associated with growth metrics among infants with LBW, suggesting that these tools may be useful to identify dyads who would benefit from early lactation support.

Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study.

BACKGROUND: Neonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH). MATERIAL AND METHODOLOGY: This was a prospective hospital-based observational study conducted at the Neonatal Ward - MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis. RESULTS: Out of 180 neonates, 39.4% (71/180) had birth weight between 1500 - 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82-0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland-Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement. CONCLUSION: The results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

Readiness to provide comprehensive emergency obstetric and neonatal care: a cross-sectional study in 30 health facilities in Tanzania.

BACKGROUND: Despite the global progress in bringing health services closer to the population, mothers and their newborns still receive substandard care leading to morbidity and mortality. Health facilities' capacity to deliver the service is a prerequisite for quality health care. This study aimed to assess health facilities' readiness to provide comprehensive emergency obstetric and newborn care (CEmONC), comprising of blood transfusion, caesarean section and basic services, and hence to inform improvement in the quality of care interventions in Tanzania. METHODS: A cross-sectional assessment of 30 CEmONC health facilities implementing the Safer Births Bundle of Care package in five regions of Tanzania was carried out between December 2020 and January 2021. We adapted the World Health Organization's Service Availability and Readiness Assessment tool to assess amenities, equipment, trained staff, guidelines, medicines, and diagnostic facilities. Composite readiness scores were calculated for each category and results were compared at the health facility level. For categorical variables, we tested for differences by Fisher's exact test; for readiness scores, differences were tested by a linear mixed model analysis, taking into account dependencies within the regions. We used p < 0.05 as our level of significance. RESULTS: The overall readiness to provide CEmONC was 69.0% and significantly higher for regional hospitals followed by district hospitals. Average readiness was 78.9% for basic amenities, 76.7% for medical equipment, 76.0% for diagnosis and treatment commodities, 63.6% for staffing and 50.0% for guidelines. There was a variation in the availability of items at the individual health facility level and across levels of facilities. We found a significant difference in the availability of basic amenities, equipment, staffing, and guidelines between regional, and district hospitals and health centres (p = 0.05). Regional hospitals had significantly higher scores of medical equipment than district hospitals and health centers (p = 0.02). There was no significant difference in the availability of commodities for diagnosis and treatment between different facility levels. CONCLUSION: Facilities' readiness was inadequate and varied across different levels of the facility. There is room to improve the facilities' readiness to deliver quality maternal and newborn care. The responsible authorities should take immediate actions to address the observed deficiencies while carefully choosing the most effective and feasible interventions and monitoring progress in readiness.

Lessons learned in implementing the Low Birthweight Infant Feeding Exploration study: A large, multi-site observational study.

OBJECTIVE: Globally, early and optimal feeding practices and strategies for small and vulnerable infants are limited. We aim to share the challenges faced and implementation lessons learned from a complex, mixed methods research study on infant feeding. DESIGN: A formative, multi-site, observational cohort study using convergent parallel, mixed-methods design. SETTING: Twelve tertiary/secondary, public/private hospitals in India, Malawi and Tanzania. POPULATION OR SAMPLE: Moderately low birthweight infants (MLBW; 1.50-2.49 kg). METHODS: We assessed infant feeding and care practices through: (1) assessment of in-facility documentation of 603 MLBW patient charts; (2) intensive observation of 148 MLBW infants during facility admission; and (3) prospective 1-year follow-up of 1114 MLBW infants. Focus group discussions and in-depth interviews gathered perspectives on infant feeding among clinicians, families, and key stakeholders. MAIN OUTCOME MEASURES: The outcomes of the primary study were: (1) To understand the current practices and standard of care for feeding LBW infants; (2) To define and document the key outcomes (including growth, morbidity, and lack of success on mother's own milk) for LBW infants under current practices; (3) To assess the acceptability and feasibility of a system-level Infant and Young Child Feeding (IYCF) intervention and the proposed infant feeding options for LBW infants. RESULTS: Hospital-level guidelines and provision of care for MLBW infants varied across and within countries. In all, 89% of charts had missing data on time to first feed and 56% lacked discharge weights. Among 148 infants observed in-facility, 18.5% were discharged prior to meeting stated weight goals. Despite challenges during COVID, 90% of the prospective cohort was followed until 12 months of age. CONCLUSIONS: Enrolment and follow-up of this vulnerable population required additional effort from researchers and the community. Using a mixed-methods exploratory study allowed for a comprehensive understanding of MLBW health and evidence-based planning of targeted large-scale interventions. Multi-site partnerships in global health research, which require active and equal engagement, are instrumental in avoiding duplication and building a stronger, generalisable evidence base.

CPAP failure in the management of preterm neonates with respiratory distress syndrome where surfactant is scarce. A prospective observational study.

BACKGROUND: The mainstay in the management of preterm neonates with respiratory distress syndrome (RDS) include early Continuous Positive Airway Pressure (CPAP), timely surfactant replacement and mechanical ventilation. Preterm neonates with RDS who fail CPAP are at higher risk for chronic lung disease as well as death. Unfortunately, in low resource settings CPAP may be the only treatment available for these neonates. OBJECTIVE: To determine the prevalence of CPAP failure among premature newborns with RDS and associated factors. METHODS: We conducted a prospective observational study over the first 72 h of life on 174 preterm newborns with RDS receiving CPAP at Muhimbili National Hospital (MNH). At MNH newborns with Silverman Andersen Score (SAS) of ≥ 3 are commenced on CPAP; surfactant and mechanical ventilation are very scarce. Study newborns not maintaining oxygen saturation > 90% or with SAS score ≥ 6 despite being on 50% oxygen and PEEP of 6 cmH2O and those with > 2 episodes of apnoea needing stimulation or positive pressure ventilation in 24 h were considered as CPAP failure. The prevalence of CPAP failure was determined as a percentage and factors associated were determined by logistic regression. A p-value of < 0.05 was considered significant and 95% confidence interval was used. RESULTS: Of the enrolled newborns, 48% were male and 91.4% were in-born. The mean gestational age and weight were 29 weeks (range 24-34 weeks) and 1157.7 g (range 800-1500 g) respectively. Of the mothers 44 (25%) received antenatal corticosteroids. Overall CPAP failure was 37.4% and among those weighing ≤ 1200g, it was 44.1% . Most failure occurred within the first 24 h. No factor was identified to be independently associated with CPAP failure. Mortality among those who failed CPAP was 33.8% and 12.8% among those who did not. CONCLUSIONS: In resource limited settings like ours with low up take of antenatal corticosteroids and scarce surfactant replacement a significant portion of preterm neonates especially those weighing ≤ 1200 g with RDS fail CPAP therapy.

Effectiveness of antenatal dexamethasone in reducing respiratory distress syndrome and mortality in preterm neonates: a nested case control study.

BACKGROUND: Respiratory distress syndrome (RDS) is a significant cause of preterm neonatal morbidity and mortality globally. Measures like the use of antenatal corticosteroids (ACS) and immediate resuscitation of the newborn after birth are taken to abate preterm related complications. Most studies that evidenced the benefit of ACS were done in high resource settings. Therefore, this study was conducted to assess the effectiveness of ACS in reducing RDS and neonatal mortality in preterm neonates in resource-limited settings. METHODS: A three months prospective nested case-control study (1:2 unmatched) was conducted at Muhimbili National Hospital and Amana regional referral hospital in Dar es salaam, Tanzania. Neonates delivered at 28 to 34 gestational weeks were enrolled and followed up until discharge. Data analysis was done using the statistical package of social sciences version 23. Logistic regression analysis was used to determine the effect of ACS on the RDS and mortality in the cohort, controlling for important maternal and neonatal variables. All tests were considered statistically significant at p < 0.05. RESULTS: Out of 330 preterm neonates enrolled, 110 were cases and 220 were controls. The median gestational age at delivery was 30 weeks and 6 days (IQR 4.68) among cases and 33 weeks (IQR 3) among controls. One-minute APGAR score of < 7 (AOR: 3.11; 95% CI 1.54-6.30), and neonatal birth weight (AOR: 0.998; 95% CI 0.997-0.999) were significantly associated with RDS. No significant association was observed between ACS exposure and RDS occurrence (AOR: 1.65; 95% CI 0.86 - 3.15). The overall mortality rate was 9 per 1000 neonates. Neonatal mortality occurred only among cases whereby, a unit increase in gestational age was associated with a 30% reduction in neonatal mortality (Adjusted hazard ratio, AHR: 0.70, 95% CI: 0.5-0.92, p = 0.011). CONCLUSION: Decrease in gestational age, one minute APGAR score of < 7 and decreasing birth weight were associated with RDS among preterm neonates. ACS was not associated with reduced RDS occurrence and neonatal mortality rates. Moreover, increase in gestation age was the only factor found to be protective against preterm neonatal mortality.

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.

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.

Midwives' perceptions on using a fetoscope and Doppler for fetal heart rate assessments during labor: a qualitative study in rural Tanzania.

BACKGROUND: The Doppler is thought to be more comfortable and effective compared to the fetoscope for assessing the fetal heart rate (FHR) during labor. However, in a rural Tanzanian hospital, midwives who had easy access to both devices mostly used fetoscope. This study explored midwives' perception of factors influencing their preference for using either a Pinard fetoscope or a FreePlay wind-up Doppler for intermittent FHR monitoring. METHODS: Midwives who had worked for at least 6 months in the labor ward were recruited. Focus group discussion (FGD) was used to collect data. Five FGDs were conducted between December 2015 and February 2016. Qualitative content analysis was employed using NVivo 11.0. RESULTS: Three main themes emerged as factors perceived by midwives as influencing their preference; 1) Sufficient training and experience with using a device; Midwives had been using fetoscopes since their midwifery training, and they had vast experience using it. The Doppler was recently introduced in the maternity ward, and midwives had insufficient training in how to use it. 2) Ability of the device to produce reliable measurements; Using a fetoscope, one must listen for the heartbeat, count using a watch, and calculate, the Doppler provides both a display and sound of the FHR. Fetoscope measurements are prone to human errors, and Doppler measurements are prone to instrumental errors. 3) Convenience of use and comfort of a device; Fetoscopes do not need charging, and while it is possible to "personalize/hide" the measurements, and may be painful for mothers. Dopplers need charging and do not cause pain, but provide limited privacy. CONCLUSION: Midwives' preferences of FHR monitoring devices are influenced by the level of device training, experience with using a device, reliable measurements, and convenience and comfort during use. Fetoscopes and Dopplers should be equally available during midwifery training and in clinical practice.

Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial.

BACKGROUND: Neonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting. METHODS: This was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120-160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained. RESULTS: A total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0.93, 2.04) in the Doppler and fetoscope arms, respectively. Bag mask ventilation was performed in 80 (6.1%) vs 82 (6.0%). (RR = 1.03; 95%CI: 0.76, 1.38) of neonates, and adverse perinatal outcome was comparable 32(2.4%) vs 35(2.5%). (RR = 0.9; 95%CI: 0.59, 1.54), in the Doppler and fetoscope arms, respectively. CONCLUSION: This trial failed to demonstrate a statistically significant difference in the detection of abnormal FHR between intermittently used Doppler and fetoscope and adverse perinatal outcomes. However, FHR measurements were not performed as often as recommended by international guidelines. Conducting a randomized controlled study in rural settings with limited resources is associated with major challenges. TRIAL REGISTRATION: This clinical trial was registered on April 2013 with registration number NCT01869582 .

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.

Bilateral cryptophthalmos with overlapping features of Manitoba oculo-tricho-anal (MOTA) syndrome and Fraser syndrome 2.

A male baby with bilateral cryptophthalmos without eyebrows, distorted anterior hairline, bifid nasal tip, low-set ears, hypertelorism and low anorectal anomaly who was phenotypically diagnosed with Manitoba oculo-tricho-anal syndrome (mutation in FREM1 gene) had an overlapping genotypic diagnosis of autosomal recessive Fraser syndrome 2 because of the presence of a closely related mutation in FREM2 This heterozygous variant was likely to be sporadic. Another mutation was identified in the CEP85L gene indicating lissencephaly 10. This genetic condition has abnormal gyri pattern in the occiput area. This form of lissencephaly is characterised by phenotypic heterogeneity whereby some patients have only mild mental retardation, while others have a very complex clinical picture.In conclusion, this rare condition with the overlap of genetics between several conditions highlights the need for genetic testing even in an low middle income country (LMIC).

Neurodevelopmental Outcome at 6 Months Following Neonatal Resuscitation in Rural Tanzania.

Early bag-mask ventilation (BMV) administered to non-breathing neonates at birth in the presence of birth asphyxia (interruption of placental blood flow) has reduced neonatal mortality by up to 50% in low- and middle-income countries. The neurodevelopmental outcome of neonates receiving BMV remains unknown. Using the Malawi Developmental Assessment Tool (MDAT), infants who received BMV at birth were assessed at 6 months, evaluating gross motor, fine motor, language and social skills. A healthy cohort with no birth complications was assessed with the same tool for comparison. Mean age-adjusted MDAT z-scores were not significantly different between the groups. The number of children having developmental delay defined as a z-score ≤ -2 was significantly higher in the resuscitated cohort for the fine motor and language domain and overall MDAT z-score. The prevalence of clinical seizures post discharge was significantly higher in the resuscitated group and was associated with neurodevelopmental delay. Infants with developmental delay or seizures were more likely to have a 5 min Apgar < 7 and a longer duration of BMV. Most children receiving BMV at birth are developing normally at 6 months. Still, there are some children with impaired development among resuscitated children, representing a subgroup of children who may have suffered more severe asphyxia.

Fetal to Neonatal Heart Rate Transition during Normal Vaginal Deliveries: A Prospective Observational Study.

Documentation of fetal to neonatal heart rate (HR) transition is limited. The aim of the current study was to describe HR changes from one hour before to one hour after normal vaginal deliveries. We conducted a prospective observational cohort study in Tanzania from 1 October 2020 to 30 August 2021, including normal vaginal deliveries with normal neonatal outcomes. HR was continuously recorded from one hour before to one hour after delivery, using the Moyo fetal HR meter, NeoBeat newborn HR meter, and the Liveborn Application for data storage. The median, 25th, and 75th HR percentiles were constructed. Overall, 305 deliveries were included. Median (interquartile range; IQR) gestational age was 39 (38-40) weeks and birthweight was 3200 (3000-3500) grams. HR decreased slightly during the last 60 min before delivery from 136 (123,145) to 132 (112,143) beats/minute. After delivery, HR increased within one minute to 168 (143,183) beats/min, before decreasing to around 136 (127,149) beats/min at 60 min after delivery. The drop in HR in the last hour of delivery reflects strong contractions and pushing. The rapid increase in initial neonatal HR reflects an effort to establish spontaneous breathing.

"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.

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.

ePOCT+ and the medAL-suite: Development of an electronic clinical decision support algorithm and digital platform for pediatric outpatients in low- and middle-income countries.

Electronic clinical decision support algorithms (CDSAs) have been developed to address high childhood mortality and inappropriate antibiotic prescription by helping clinicians adhere to guidelines. Previously identified challenges of CDSAs include their limited scope, usability, and outdated clinical content. To address these challenges we developed ePOCT+, a CDSA for the care of pediatric outpatients in low- and middle-income settings, and the medical algorithm suite (medAL-suite), a software for the creation and execution of CDSAs. Following the principles of digital development, we aim to describe the process and lessons learnt from the development of ePOCT+ and the medAL-suite. In particular, this work outlines the systematic integrative development process in the design and implementation of these tools required to meet the needs of clinicians to improve uptake and quality of care. We considered the feasibility, acceptability and reliability of clinical signs and symptoms, as well as the diagnostic and prognostic performance of predictors. To assure clinical validity, and appropriateness for the country of implementation the algorithm underwent numerous reviews by clinical experts and health authorities from the implementing countries. The digitalization process involved the creation of medAL-creator, a digital platform which allows clinicians without IT programming skills to easily create the algorithms, and medAL-reader the mobile health (mHealth) application used by clinicians during the consultation. Extensive feasibility tests were done with feedback from end-users of multiple countries to improve the clinical algorithm and medAL-reader software. We hope that the development framework used for developing ePOCT+ will help support the development of other CDSAs, and that the open-source medAL-suite will enable others to easily and independently implement them. Further clinical validation studies are underway in Tanzania, Rwanda, Kenya, Senegal, and India.

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.

Feasibility of a novel ultra-low-cost bubble CPAP (bCPAP) System for neonatal respiratory support at Muhimbili National Hospital, Tanzania.

OBJECTIVE: Continuous Positive Airway Pressure (CPAP) is recommended in the treatment of respiratory distress syndrome of premature newborns, however there are significant barriers to its implementation in low-resource settings. The objective of this study was to evaluate the feasibility of use and integration of Vayu bCPAP Systems into the newborn unit at Muhimbili National Hospital in Tanzania. STUDY DESIGN: A prospective qualitative study was conducted from April 6 to October 6 2021. Demographic and clinical characteristics of patients treated with Vayu bCPAP Systems were collected and analyzed. Healthcare workers were interviewed until thematic saturation. Interviews were transcribed, coded, and analyzed using a framework analysis. RESULTS: 370 patients were treated with Vayu bCPAP Systems during the study period. Mean birth weight was 1522 g (500-3800), mean duration of bCPAP treatment was 7.2 days (<1-39 d), and survival to wean was 81.4%. Twenty-four healthcare workers were interviewed and perceived Vayu bCPAP Systems as having become essential for treating neonatal respiratory distress at MNH. Key reasons were that Vayu bCPAP Systems improve patient outcomes, are easy to use, and more patients are now able to receive quality care. Barriers to integration included durability of oxygen tubing material and training. CONCLUSIONS: It was feasible to implement and integrate Vayu bCPAP Systems into the care of neonates at Muhimbili National Hospital.