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BackgroundPreterm birth is the leading cause of death in children younger than 5 years worldwide. WHO recommends kangaroo mother care (KMC); however, its effects on mortality in sub-Saharan Africa and its relative costs remain unclear. We aimed to compare the effectiveness, safety, costs, and cost-effectiveness of KMC initiated before clinical stabilisation versus standard care in neonates weighing up to 2000 g.MethodsWe conducted a parallel-group, individually randomised controlled trial in five hospitals across Uganda. Singleton or twin neonates aged younger than 48 h weighing 700-2000 g without life-threatening clinical instability were eligible for inclusion. We randomly assigned (1:1) neonates to either KMC initiated before stabilisation (intervention group) or standard care (control group) via a computer-generated random allocation sequence with permuted blocks of varying sizes, stratified by birthweight and recruitment site. Parents, caregivers, and health-care workers were unmasked to treatment allocation; however, the independent statistician who conducted the analyses was masked. After randomisation, neonates in the intervention group were placed prone and skin-to-skin on the caregiver's chest, secured with a KMC wrap. Neonates in the control group were cared for in an incubator or radiant heater, as per hospital practice; KMC was not initiated until stability criteria were met. The primary outcome was all-cause neonatal mortality at 7 days, analysed by intention to treat. The economic evaluation assessed incremental costs and cost-effectiveness from a disaggregated societal perspective. This trial is registered with ClinicalTrials.gov, NCT02811432.FindingsBetween Oct 9, 2019, and July 31, 2022, 2221 neonates were randomly assigned: 1110 (50·0%) neonates to the intervention group and 1111 (50·0%) neonates to the control group. From randomisation to age 7 days, 81 (7·5%) of 1083 neonates in the intervention group and 83 (7·5%) of 1102 neonates in the control group died (adjusted relative risk [RR] 0·97 [95% CI 0·74-1·28]; p=0·85). From randomisation to 28 days, 119 (11·3%) of 1051 neonates in the intervention group and 134 (12·8%) of 1049 neonates in the control group died (RR 0·88 [0·71-1·09]; p=0·23). Even if policy makers place no value on averting neonatal deaths, the intervention would have 97% probability from the provider perspective and 84% probability from the societal perspective of being more cost-effective than standard care.InterpretationKMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care. Additional investment in neonatal care is needed for increased impact, particularly in sub-Saharan Africa.FundingJoint Global Health Trials scheme of the Department of Health and Social Care, Foreign, Commonwealth and Development Office, UKRI Medical Research Council, and Wellcome Trust; Eunice Kennedy Shriver National Institute of Child Health and Human Development.

We propose a detailed framework for contraceptive agency to serve as a rights-based guide for centering individuals’ ability to make and act on their own contraceptive choices, regardless of what those choices are, in program design and evaluation.

BackgroundA shortage of community health workers to triage sick neonates and poor recognition of neonatal illness by mothers contribute significantly toward neonatal deaths in low- and middle-income countries. Providing low-resource communities with the tools and knowledge to recognize signs of neonatal distress can lead to early care-seeking behavior. To empower and educate mothers to recognize signs of neonatal illness, we developed a neonatal health assessment device consisting of a smartphone app and a wearable sensor (the NeMo system). ObjectiveThe aim of this study was to determine if mothers in rural Uganda were willing and able to use the NeMo system during the first week of their infant’s life. We also assessed mothers’ responses to the device’s recommendation to seek care. MethodsA total of 20 mothers were enrolled in the study after giving birth in the Iganga District Hospital. Each mother was trained to use the NeMo system to assess her infant for signs of illness before leaving the hospital and was given the NeMo system to use at home for 1 week. Throughout the week, the smartphone tracked the mothers’ usage of NeMo, and the study team visited twice to observe mothers’ ability to use NeMo. Each mother was interviewed at the end of 1 week to gather qualitative feedback on her experience with the NeMo system. ResultsIn total, 18 mothers completed the study; 2 mothers were withdrawn during the week because of extenuating health circumstances. Moreover, 1 day after enrollment and training, 75% (15/20) of mothers used NeMo properly with no mistakes. Three days after enrollment and training, only 1 mother placed the wearable sensor improperly on her infant. On the final study day, only 1 mother connected the device improperly. Mothers used NeMo an average of 11.67 (SD 5.70) times on their own at home during the 5 full study days. Although the frequency of use per day decreased from day 1 to day 5 of the study (P=.04), 72% (13/18) of mothers used NeMo at least once per day. In total, 64% (9/14) of mothers who received an alert from the NeMo system to seek care for their infants either called the health care professional working with the study team or reused the system immediately and found no danger signs. All 18 mothers agreed or strongly agreed that the NeMo system was easy to use and helped them know when to seek care for their babies. ConclusionsNeMo is a feasible and acceptable tool to aid mothers in rural Uganda to assess their infant’s health.

BackgroundWhile early identification of neonatal illness can impact neonatal mortality rates and reduce the burden of treatment, identifying subtle clinical signs and symptoms of possible severe illness is especially challenging in neonates. The World Health Organization and the United Nations Children’s Fund developed the Integrated Management of Neonatal Childhood Illness guidelines, an evidence-based tool highlighting seven danger signs to assess neonatal health. Currently, many mothers in low-resource settings rely on home visits from community health workers (CHWs) to determine if their baby is sick. However, CHWs visit infrequently, and illness is often detected too late to impact survival. Thus, delays in illness identification pose a significant barrier to providing expedient and effective care. Neonatal Monitoring (NeMo), a novel neonatal assessment tool, seeks to increase the frequency of neonatal screening by task-shifting identification of neonatal danger signs from CHWs to mothers. ObjectiveThis study aimed to explore the usability and acceptability of the NeMo system among target users and volunteer CHWs by assessing ease of use and learnability. MethodsSimulated device use and semistructured interviews were conducted with 32 women in the Iganga-Mayuge districts in eastern Uganda to evaluate the usability of the NeMo system, which involves a smartphone app paired with a low cost, wearable band to aid in identification of neonatal illness. Two versions of the app were evaluated using a mixed methods approach, and version II of the app contained modifications based on observations of the first cohort’s use of the system. During the posed scenario simulations, participants were offered limited guidance from the study team in order to probe the intuitiveness of the NeMo system. The ability to complete a set of tasks with the system was tested and recorded for each participant and closed- and open-ended questions were used to elicit user feedback. Additionally, focus groups with 12 CHWs were conducted to lend additional context and insight to the usability and feasibility assessment. ResultsA total of 13/22 subjects (59%) using app version I and 9/10 subjects (90%) using app version II were able to use the phone and app with no difficulty, despite varying levels of smartphone experience. Following modifications to the app’s audio instructions in version II, participants’ ability to accurately answer qualitative questions concerning neonatal danger signs improved by at least 200% for each qualitative danger sign. All participants agreed they would trust and use the NeMo system to assess the health of their babies. Furthermore, CHWs emphasized the importance of community sensitization towards the system to encourage its adoption and regular use, as well as the decision to seek care based on its recommendations. ConclusionsThe NeMo system is an intuitive platform for neonatal assessment in a home setting and was found to be acceptable to women in rural Uganda.

BACKGROUND: Quality improvement collaboratives (QIC) are an approach to accelerate the spread and impact of evidence-based interventions across health facilities, which are found to be particularly successful when combined with other interventions such as clinical skills training. We implemented a QIC as part of a quality improvement intervention package designed to improve newborn survival in Kenya and Uganda. We use a multi-method approach to describe how a QIC was used as part of an overall improvement effort and describe specific changes measured and participant perceptions of the QIC. METHODS: We examined QIC-aggregated run charts on three shared indicators related to uptake of evidence-based practices over time and conducted key informant interviews to understand participants perceptions of quality improvement practice. Run charts were evaluated for change from baseline medians. Interviews were analysed using framework analysis. RESULTS: Run charts for all indicators reflected an increase in evidence-based practices across both countries. In Uganda, pre-QIC median gestational age (GA) recording of 44% improved to 86%, while Kangaroo Mother Care (KMC) initiation went from 51% to 96% and appropriate antenatal corticosteroid (ACS) use increased from 17% to 74%. In Kenya, these indicators went from 82% to 96%, 4% to 74% and 4% to 57%, respectively. Qualitative results indicate that participants appreciated the experience of working with data, and the friendly competition of the QIC was motivating. The participants reported integration of the QIC with other interventions of the package as a benefit. CONCLUSIONS: In a QIC that demonstrated increased evidence-based practices, QIC participants point to data use, friendly competition and package integration as the drivers of success, despite challenges common to these settings such as health worker and resource shortages. TRIAL REGISTRATION NUMBER: NCT03112018.

Across research disciplines, cluster randomized trials (CRTs) are commonly implemented to evaluate interventions delivered to groups of participants, such as communities and clinics. Despite advances in the design and analysis of CRTs, several challenges remain. First, there are many possible ways to specify the causal effect of interest (eg, at the individual-level or at the cluster-level). Second, the theoretical and practical performance of common methods for CRT analysis remain poorly understood. Here, we present a general framework to formally define an array of causal effects in terms of summary measures of counterfactual outcomes. Next, we provide a comprehensive overview of CRT estimators, including the t-test, generalized estimating equations (GEE), augmented-GEE, and targeted maximum likelihood estimation (TMLE). Using finite sample simulations, we illustrate the practical performance of these estimators for different causal effects and when, as commonly occurs, there are limited numbers of clusters of different sizes. Finally, our application to data from the Preterm Birth Initiative (PTBi) study demonstrates the real-world impact of varying cluster sizes and targeting effects at the cluster-level or at the individual-level. Specifically, the relative effect of the PTBi intervention was 0.81 at the cluster-level, corresponding to a 19% reduction in outcome incidence, and was 0.66 at the individual-level, corresponding to a 34% reduction in outcome risk. Given its flexibility to estimate a variety of user-specified effects and ability to adaptively adjust for covariates for precision gains while maintaining Type-I error control, we conclude TMLE is a promising tool for CRT analysis.

BackgroundPreterm birth complications result in > 1 million child deaths annually, mostly in low- and middle-income countries. A World Health Organisation (WHO)-led trial in hospitals with intensive care reported reduced mortality within 28 days among newborns weighing 1000-1799 g who received immediate kangaroo mother care (iKMC) compared to those who received standard care. Evidence is needed regarding the process and costs of implementing iKMC, particularly in non-intensive care settings.MethodsWe describe actions undertaken to implement iKMC, estimate financial and economic costs of essential resources and infrastructure improvements, and assess readiness for newborn care after these improvements at five Ugandan hospitals participating in the OMWaNA trial. We estimated costs from a health service provider perspective and explored cost drivers and cost variation across hospitals. We assessed readiness to deliver small and sick newborn care (WHO level-2) using a tool developed by Newborn Essential Solutions and Technologies and the United Nations Children's Fund.ResultsFollowing the addition of space to accommodate beds for iKMC, floor space in the neonatal units ranged from 58 m2 to 212 m2. Costs of improvements were lowest at the national referral hospital (financial: $31,354; economic: $45,051; 2020 USD) and varied across the four smaller hospitals (financial: $68,330-$95,796; economic: $99,430-$113,881). In a standardised 20-bed neonatal unit offering a level of care comparable to the four smaller hospitals, the total financial cost could be in the range of $70,000 to $80,000 if an existing space could be repurposed or remodelled, or $95,000 if a new unit needed to be constructed. Even after improvements, the facility assessments demonstrated broad variability in laboratory and pharmacy capacity as well as the availability of essential equipment and supplies.ConclusionsThese five Ugandan hospitals required substantial resource inputs to allow safe implementation of iKMC. Before widespread scale-up of iKMC, the affordability and efficiency of this investment must be assessed, considering variation in costs across hospitals and levels of care. These findings should help inform planning and budgeting as well as decisions about if, where, and how to implement iKMC, particularly in settings where space, devices, and specialised staff for newborn care are unavailable.Trial registrationClinicalTrials.gov, NCT02811432 . Registered: 23 June 2016.

Equating contraceptive use with programmatic success is fundamentally flawed in failing to account for whether individuals desire contraceptive use; this is problematic because nonuse can reflect empowered decision-making and use may reflect an individual's inability to refuse or discontinue a method. A rights-based approach demands respect for individuals' freedom to weigh options and choose how their desire for pregnancy prevention can be accommodated by available methods and within the context of their own personal, social, and material constraints. We offer an alternative construct, preference-aligned fertility management (PFM), that provides a more holistic indicator of whether one's contraceptive needs are met. PFM is more person-centered and informative for programming than status quo measures of unmet need, demand satisfied, and contraceptive use which define a positive outcome in relation to pregnancy risk rather than one's stated preferences. The PFM approach goes beyond other recent proposals for modifying the concept of unmet need by refraining from judgment of legitimate reasons for nonuse of contraception and offers a straightforward way to capture whether people act in line with their preferences. We conclude with discussion of how we plan to measure PFM in the Innovations for Choice and Autonomy (ICAN) study in Nigeria and Uganda.

BackgroundThe WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned.MethodsThe East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis.ResultsA total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues.ConclusionThis study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.

ObjectivesGlobally, hundreds of women die daily from preventable pregnancy-related causes, with the greatest burden in sub-Saharan Africa. Five key emergencies-bleeding, infections, high blood pressure, delivery complications and unsafe abortions-account for nearly 75% of these obstetric deaths. Skilled clinicians with strategic supplies could prevent most deaths. In this study, we (1) measured facility readiness to manage common obstetric emergencies using the clinical cascades and signal function tracers; (2) compared these readiness estimates by facility characteristics; and (3) measured cascading drop-offs in resources.DesignA facility-based cross-sectional analysis of resources for common obstetric emergencies.SettingData were collected in 2016 from 23 hospitals (10 designated comprehensive emergency obstetric care (CEmOC) facilities) in Migori County, western Kenya, and Busoga Region, eastern Uganda, in the Preterm Birth Initiative study in East Africa. Baseline data were used to estimate a facility's readiness to manage common obstetric emergencies using signal function tracers and the clinical cascade model. We compared emergency readiness using the proportion of facilities with tracers (signal functions) and the proportion with resources for identifying and treating the emergency (cascade stages 1 and 2).ResultsThe signal functions overestimated practical emergency readiness by 23 percentage points across five emergencies. Only 42% of CEmOC-designated facilities could perform basic emergency obstetric care. Across the three stages of care (identify, treat and monitor-modify) for five emergencies, there was a 28% pooled mean drop-off in readiness. Across emergencies, the largest drop-off occurred in the treatment stage. Patterns of drop-off remained largely consistent across facility characteristics.ConclusionsAccurate measurement of obstetric emergency readiness is a prerequisite for strengthening facilities' capacity to manage common emergencies. The cascades offer stepwise, emergency-specific readiness estimates designed to guide targeted maternal survival policies and programmes.Trial registration numberNCT03112018.

ObjectiveTo investigate the interaction of risks for adverse maternal and perinatal outcomes (stillbirth, predischarge neonatal and maternal mortality) among caesarean section (CS) compared with vaginal deliveries (VD).DesignProspective cohort study.Setting10 CS-capable facilities in Busoga Region, East-Central Uganda and Migori County, Kenya.ParticipantsIndividual birth data were extracted from maternity registers between October 2016 and April 2019. There were a total of 77 242 livebirths and 3734 stillbirths. Overall, 24% of deliveries were by CS with a range of 9%-49% across facilities.Primary outcome measuresStillbirth, predischarge neonatal mortality and maternal mortality.ResultsThe adjusted ORs for stillbirth, predischarge neonatal mortality and maternal mortality after a CS were 1.3 (95% CI 1.1 to 1.6), 1.9 (95% CI 1.6 to 2.2) and 3.3 (95% CI 2.2 to 4.9), respectively, compared with a VD. The association between maternal mortality and CS was 3.9 (95% CI 2.8 to 5.5) when the delivery was a live birth and 1.7 (95% CI 1.0 to 3.0) when it was a stillbirth. Post hoc analyses showed that mothers who received a CS had a lower risk of stillbirth if they were documented as a referral.ConclusionIn this context, CS births were at higher risk for worse outcomes compared with VD. Better understanding of CS use and associated adverse outcomes within the mother-baby dyad is necessary to identify opportunities to improve quality of intrapartum care.Trial registration numberNCT03112018.

BackgroundA large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda.MethodsEligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers.ResultsOf the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); Pinteraction  = 0.025. These trends were similar after excluding the PTBi primary cohort.ConclusionsThe intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries.RegistrationThis trial is registered with ClinicalTrials.gov, NCT03112018.

IntroductionKangaroo mother care (KMC) is among the most cost-effective and easily accessible solutions for improving the survival and wellbeing of small newborns. In this study, we examined the barriers and facilitators to continuity of KMC at home following hospital discharge in rural Uganda.MethodsWe conducted this study in five districts in east-central Uganda, within six hospitals and at the community level. We used a qualitative approach, with two phases of data collection. Phase 1 comprised in-depth interviews with mothers who practiced KMC with their babies and caretakers who supported them and key informant interviews with health workers, district health office staff, community health workers, and traditional birth attendants. We then conducted group discussions with mothers of small newborns and their caretakers. We held 65 interviews and five group discussions with 133 respondents in total and used a thematic approach to data analysis.ResultsIn hospital, mothers were sensitized and taught KMC. They were expected to continue practicing it at home with regular returns to the hospital post-discharge. However, mothers practiced KMC for a shorter time at home than in the hospital. Reasons included being overburdened with competing domestic chores that did not allow time for KMC and a lack of community follow-up support by health workers. There were increased psycho-social challenges for mothers, alongside some dangerous practices like placing plastic cans of hot water near the baby to provide warmth. Respondents suggested various ways to improve the KMC experience at home, including the development of a peer-to-peer intervention led by mothers who had successfully done KMC and community follow-up of mothers by qualified health workers and community health workers.ConclusionDespite wide acceptance of KMC by health workers, challenges to effective implementation persist. Amid the global and national push to scale up KMC, potential difficulties to its adherence post-discharge in a rural, resource-limited setting remain. This study provides insights on KMC implementation and sustainability from the perspectives of key stakeholders, highlighting the need for a holistic approach to KMC that incorporates its adaptability to community settings and contexts.

BackgroundQuality of care during the intrapartum and immediate postnatal period for maternal and newborn health remains a major challenge due to the multiple health system bottlenecks in low-income countries. Reports of complex interventions that have been effective in reducing maternal and newborn mortality in these settings are usually limited in description, which inhibits learning and replication. We present a detailed account of the Preterm Birth Initiative (PTBi) implementation process, experiences and lessons learnt to inform scale-up and replication.MethodsUsing the TiDieR framework, we detail how the PTBi implemented an integrated package of interventions through a pair-matched cluster randomized control trial in 20 health facilities in Migori County, Kenya, and the Busoga region in east central Uganda from 2016 to 2019. The package aimed to improve quality of care during the intrapartum and immediate postnatal period with a focus on preterm birth. The package included data strengthening (DS) and introduction of a modified WHO Safe Childbirth Checklist (mSCC), simulation-based training and mentoring (PRONTO), and a Quality Improvement (QI) Collaborative.ResultsIn 2016, DS and mSCC were introduced to improve existing data processes and increase the quality of data for measures needed to evaluate study impact. PRONTO and QI interventions were then rolled out sequentially. While package components were implemented with fidelity, some implementation processes required contextual adaptation to allow alignment with national priorities and guidelines, and flexibility to optimize uptake.ConclusionLessons learned included the importance of synergy between interventions, the need for local leadership engagement, and the value of strengthening local systems and resources. Adaptations of individual elements of the package to suit the local context were important for effective implementation, and the TIDieR framework provides the guidance needed in detailed description to replicate such a complex intervention in other settings. Detailed documentation of the implementation process of a complex intervention with mutually synergistic components can help contextualize trial results and potential for scale-up. The trial is registered at ClinicalTrials.gov NCT03112018 , registered December 2016, posted April 2017.

ObjectiveTo test whether introduction of a midwife-performed triage checklist and focused ultrasound improves diagnosis and referral for obstetric conditions, including multiple gestation, placenta previa, oligohydramnios, preterm birth, malpresentation, and abnormal fetal heart rate.MethodsWe implemented an intake log (Phase 1), a checklist (Phase 2), and a checklist plus ultrasound scan (Phase 3) at three primary health centers in Eastern Uganda for women presenting in labor. Intake diagnoses, referral status, and delivery outcomes were assessed, as well as sensitivity and positive predictive value (PPV).ResultsBetween February 2018 and July 2019, 1155, 961, and 603 women were enrolled across the three phases (n=2719); 2339 had outcome data. Incidence of any outcome-confirmed condition was 8.8%, 7.9%, and 7.1% (P=0.526) for each phase, respectively. The proportion of referred women with a condition did not change between Phases 1 and 2 (7.8% versus 8.6%, P=0.855), but increased in Phase 3 (48.4%, P

The COVID-19 pandemic is disrupting health systems globally. Maternity care disruptions have been surveyed, but not those related to vulnerable small newborns. We aimed to survey reported disruptions to small and sick newborn care worldwide and undertake thematic analysis of healthcare providers' experiences and proposed mitigation strategies. Using a widely disseminated online survey in three languages, we reached out to neonatal healthcare providers. We collected data on COVID-19 preparedness, effects on health personnel and on newborn care services, including kangaroo mother care (KMC), as well as disruptors and solutions. We analysed 1120 responses from 62 countries, mainly low and middle-income countries (LMICs). Preparedness for COVID-19 was suboptimal in terms of guidelines and availability of personal protective equipment. One-third reported routine testing of all pregnant women, but 13% had no testing capacity at all. More than 85% of health personnel feared for their own health and 89% had increased stress. Newborn care practices were disrupted both due to reduced care-seeking and a compromised workforce. More than half reported that evidence-based interventions such as KMC were discontinued or discouraged. Separation of the mother-baby dyad was reported for both COVID-positive mothers (50%) and those with unknown status (16%). Follow-up care was disrupted primarily due to families' fear of visiting hospitals (~73%). Newborn care providers are stressed and there is lack clarity and guidelines regarding care of small newborns during the pandemic. There is an urgent need to protect life-saving interventions, such as KMC, threatened by the pandemic, and to be ready to recover and build back better.

BackgroundThere are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention's effects and assessing incremental costs and cost-effectiveness between arms.MethodsWe will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700-≤ 2000 g and aged ≥ 1-

BackgroundAn estimated 2.8 million neonatal deaths occur each year globally, which accounts for at least 45% of deaths in children aged less than 5 years. Birthweight and gestational age-specific mortality estimates are limited in low-resource countries like Uganda. A deeper analysis of mortality by birthweight and gestational age is critical in identifying the cause and potential solutions to decrease neonatal mortality.ObjectivesWe studied mortality before discharge in relation to birthweight and gestational age using a large sample size from selected tertiary care facilities in Uganda.MethodsWe used secondary data from the East Africa Preterm Birth Initiative study conducted in six tertiary care facilities. Birth records of infants born between October 2016 and March 2019 with a gestational age greater than or equal to 24 weeks and/or birthweight greater than or equal to 500 g were reviewed for inclusion in the analysis. Newborn death before discharge was the outcome variable of interest. Multivariable Poisson regression modeling was used to explore birthweight and gestational age-specific mortality rate.ResultsWe analysed 50 278 birth records. Among these 95.3% (47 913) were live births and 4.8% (2365) were stillbirths. Of the 47 913 live births, 50% (24 147) were males. Overall, pre-discharge mortality was 13.0 per 1000 live births. For each 1 kg increase in birthweight, mortality before discharge decreased by -0.016. As birthweight increases, the mortality before discharge decreased from 336 per 1000 live births among infants born between 500 and 999 g, to 4.7 per 1000 live births among infants born weighing 3500 to 3999 g, and increased again to 11.2 per 1000 live births among infants weighing more than 4500 g.ConclusionsOur study highlights the need for further research to understand newborn survival across different birthweight and gestational categories.

BackgroundAlthough gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised.MethodsThis unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018.FindingsBetween Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found.InterpretationFresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening.FundingBill & Melinda Gates Foundation.

Background78% of neonatal deaths occur in sub-Saharan Africa and southern Asia, among which, more than 80% are in low birthweight babies. Existing neonatal mortality risk scores have primarily been developed for high-resource settings. The aim of this study was to develop and validate a score that is practicable for low-income and middle-income countries to predict in-hospital mortality among neonates born weighing 2000 g or less using datasets from the UK and The Gambia.MethodsThis analysis used retrospective data held in the UK National Neonatal Research Database from 187 neonatal units, and data from the Edward Francis Small Teaching Hospital (EFSTH), Banjul, The Gambia. In the UK dataset, neonates were excluded if birthweight was more than 2000 g; if the neonate was admitted aged more than 6 h or following discharge; if the neonate was stillborn; if the neonate died in delivery room; or if they were moribund on admission. The Gambian dataset included all neonates weighing less than 2000 g who were admitted between May 1, 2018, and Sept 30, 2019, who were screened for but not enrolled in the Early Kangaroo Mother Care Trial. 18 studies were reviewed to generate a list of 84 potential parameters. We derived a model to score in-hospital neonatal mortality risk using data from 55 029 admissions to a random sample of neonatal units in England and Wales from Jan 1, 2010, to Dec 31, 2016. All candidate variables were included in a complete multivariable model, which was progressively simplified using reverse stepwise selection. We validated the new score (NMR-2000) on 40 329 admissions to the remaining units between the same dates and 14 818 admissions to all units from Jan 1, to Dec 31, 2017. We also validated the score on 550 neonates admitted to the EFSTH in The Gambia.Findings18 candidate variables were selected for inclusion in the modelling process. The final model included three parameters: birthweight, admission oxygen saturation, and highest level of respiratory support within 24 h of birth. NMR-2000 had very good discrimination and goodness-of-fit across the UK samples, with a c-index of 0·8859-0·8930 and a Brier score of 0·0232-0·0271. Among Gambian neonates, the model had a c-index of 0·8170 and a Brier score of 0·1688. Predictive ability of the simplified integer score was similar to the model using regression coefficients, with c-indices of 0·8903 in the UK full validation sample and 0·8082 in the Gambian validation sample.InterpretationNMR-2000 is a validated mortality risk score for hospitalised neonates weighing 2000 g or less in settings where pulse oximetry is available. The score is accurate and simplified for bedside use. NMR-2000 requires further validation using a larger dataset from low-income and middle-income countries but has the potential to improve individual and population-level neonatal care resource allocation.FundingBill & Melinda Gates Foundation; Eunice Kennedy Shriver National Institute of Child Health & Human Development; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust.

ObjectivePreterm birth is the primary driver of neonatal mortality worldwide, but it is defined by gestational age (GA) which is challenging to accurately assess in low-resource settings. In a commitment to reducing preterm birth while reinforcing and strengthening facility data sources, the East Africa Preterm Birth Initiative (PTBi-EA) chose eligibility criteria that combined GA and birth weight. This analysis evaluated the quality of the GA data as recorded in maternity registers in PTBi-EA study facilities and the strength of the PTBi-EA eligibility criteria.MethodsWe conducted a retrospective analysis of maternity register data from March-September 2016. GA data from 23 study facilities in Migori, Kenya and the Busoga Region of Uganda were evaluated for completeness (variable present), consistency (recorded versus calculated GA), and plausibility (falling within the 3rd and 97th birth weight percentiles for GA of the INTERGROWTH-21st Newborn Birth Weight Standards). Preterm birth rates were calculated using: 1) recorded GA

INTRODUCTION:As facility-based deliveries increase globally, maternity registers offer a promising way of documenting pregnancy outcomes and understanding opportunities for perinatal mortality prevention. This study aims to contribute to global quality improvement efforts by characterizing facility-based pregnancy outcomes in Kenya and Uganda including maternal, neonatal, and fetal outcomes at the time of delivery and neonatal discharge outcomes using strengthened maternity registers. METHODS:Cross sectional data were collected from strengthened maternity registers at 23 facilities over 18 months. Data strengthening efforts included provision of supplies, training on standard indicator definitions, and monthly feedback on completeness. Pregnancy outcomes were classified as live births, early stillbirths, late stillbirths, or spontaneous abortions according to birth weight or gestational age. Discharge outcomes were assessed for all live births. Outcomes were assessed by country and by infant, maternal, and facility characteristics. Maternal mortality was also examined. RESULTS:Among 50,981 deliveries, 91.3% were live born and, of those, 1.6% died before discharge. An additional 0.5% of deliveries were early stillbirths, 3.6% late stillbirths, and 4.7% spontaneous abortions. There were 64 documented maternal deaths (0.1%). Preterm and low birthweight infants represented a disproportionate number of stillbirths and pre-discharge deaths, yet very few were born at ≤1500g or

BACKGROUND:Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal period. This paper describes our study protocol for implementing and evaluating a package of facility-based interventions to improve care during this critical window. METHODS/DESIGN:This is a pair-matched, cluster randomized controlled trial across 20 facilities in Eastern Uganda and Western Kenya. The intervention facilities receive four components: (1) strengthening of routine data collection and data use activities; (2) implementation of the WHO Safe Childbirth Checklist modified for preterm birth; (3) PRONTO simulation training and mentoring to strengthen intrapartum and immediate newborn care; and (4) support of quality improvement teams. The control facilities receive both data strengthening and introduction of the modified checklist. The primary outcome for this study is 28-day mortality rate among preterm infants. The denominator will include all live births and fresh stillbirths weighing greater than 1000 g and less than 2500 g; all live births and fresh stillbirths weighing between 2501 and 3000 g with a documented gestational age less than 37 weeks. DISCUSSION:The results of this study will inform interventions to improve personnel and facility capacity to respond to preterm labor and delivery, as well as care for the preterm infant. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03112018 . Registered on 13 April 2017.

Kangaroo mother care (KMC) is a safe and effective method of reducing neonatal mortality in resource-limited settings, but there has been a lack of data on the duration of skin-to-skin contact (SSC) in busy, low-resource newborn units. Previous studies of intermittent KMC suggest the duration of SSC ranged from 10 minutes to 17 hours per day. This was an observational study of newborn infants born weighing less than 2000 g, which collected quantitative data on SSC over the first week after birth. The study took place in July 2016 in the newborn unit of a low-resource facility in Uganda. The mean daily duration of SSC over the first week after birth was three hours. This differed significantly from the World Health Organization recommendation of at least 20 hours of SSC per day. SSC was provided by mothers most of the time (73.5%), but other family members also took part, especially on the day of birth. Our study found a disappointingly low daily duration of SSC in this Ugandan newborn unit. However, advocacy and community education of SSC may help to decrease the stigma of KMC, improve overall acceptance and reduce the age at SSC initiation.

BackgroundKangaroo mother care (KMC) for stable neonates ≤2000 g (g) is associated with decreased mortality, sepsis, hypothermia, and length of stay compared to conventional care. The World Health Organization states that KMC "should be initiated… as soon as newborns are clinically stable" [12]. However, the majority of deaths occur in unstable neonates. We aimed to determine the proportion of admitted neonates meeting proposed instability criteria, assess the feasibility of providing KMC to unstable neonates, and evaluate the acceptability of this intervention to parents and providers at Jinja Regional Referral Hospital in Uganda.MethodsThis was a mixed-methods study. We recorded data including birthweight, chronological age, and treatments administered from medical charts, and calculated the percentage of clinically unstable neonates, defined as the need for ≥2 medical therapies in the first 48 hours of admission. We enrolled a sample of neonates meeting pre-defined instability criteria. Mothers were counselled to provide KMC as close to continuously as possible. We calculated the median duration of KMC per episode and per day. To explore acceptability, we conducted semi-structured interviews with parents and newborn unit care providers, and analysed data using the thematic content approach.FindingsWe included 254 neonates in the audit, 10 neonates in the feasibility sub-study, and 20 participants in the acceptability sub-study. Instability criteria were easily implementable, identifying 89% of neonates as unstable in the audit. The median duration of individual KMC episodes ranged from 115 to 134 minutes. The median daily duration ranged from 4.5 to 9.7 hours. Seventy-five percent of interviewees felt KMC could be used in neonates concurrently receiving other medical therapies. Barriers included lack of resources (beds/space, monitoring devices), privacy issues, inadequate education, and difficulties motivating mothers to devote time to KMC. Recommendations included staff/peer counselling, resources, family support, and community outreach.ConclusionsThere remains a need for an evidence-based approach to consistently define stability criteria for KMC to improve care. We found that KMC for unstable neonates weighing ≤2000g was feasible and acceptable at Jinja Hospital in Uganda. Randomised controlled trials are needed to demonstrate the effect of KMC on survival among unstable neonates in low-resource settings.

BackgroundGlobally, there were 2.7 million neonatal deaths in 2015. Significant mortality reduction could be achieved by improving care in low- and middle-income countries (LMIC), where the majority of deaths occur. Determining the physical readiness of facilities to identify and manage complications is an essential component of strategies to reduce neonatal mortality.MethodsWe developed clinical cascades for 6 common neonatal conditions then utilized these to assess 23 health facilities in Kenya and Uganda at 2 time-points in 2016 and 2017. We calculated changes in resource availability over time by facility using McNemar's test. We estimated mean readiness and loss of readiness for the 6 conditions and 3 stages of care (identification, treatment, monitoring-modifying treatment). We estimated overall mean readiness and readiness loss across all conditions and stages. Finally, we compared readiness of facilities with a newborn special care unit (NSCU) to those without using the two-sample test of proportions.ResultsThe cascade model estimated mean readiness of 26.3-26.6% across the 3 stages for all conditions. Mean readiness ranged from 11.6% (respiratory distress-apnea) to 47.8% (essential newborn care) across both time-points. The model estimated overall mean readiness loss of 30.4-31.9%. There was mild to moderate variability in the timing of readiness loss, with the majority occurring in the identification stage. Overall mean readiness was higher among facilities with a NSCU (36.8%) compared to those without (20.0%).ConclusionThe cascade model provides a novel approach to quantitatively assess physical readiness for neonatal care. Among 23 facilities in Kenya and Uganda, we identified a consistent pattern of 30-32% readiness loss across cascades and stages. This aggregate measure could be used to monitor and compare readiness at the facility-, health system-, or national-level. Estimates of readiness and loss of readiness may help guide strategies to improve care, prioritize resources, and promote neonatal survival in LMICs.