Feasibility and acceptability of a novel biomedical device to prevent neonatal hypothermia and augment Kangaroo Mother Care in Kenya: Qualitative analysis of focus group discussions and key Informant Interviews.

Hypothermia is a leading newborn complication, especially among premature and/or low birth weight infants. Within low/middle-income countries where incubators and radiant warmers are often in short supply, leading to gaps in the thermal care chain, neonatal hypothermia underlies high rates of newborn morbidity and mortality. Kangaroo Mother Care/Skin-to-skin care is an effective method for prevention of hypothermia in premature and low birthweight babies but can be very burdensome for families and healthcare providers. Our international multidisciplinary team has developed a prototype for a wearable biomedical device ("NeoWarm") to provide continuous thermal care and augment kangaroo mother care practices in low-resource settings. The objective of this study was to assess the feasibility and acceptability of NeoWarm and to obtain user design feedback for an early prototype from among adult end-users in Western Kenya. We performed key informant interviews (n = 17) among healthcare providers and 5 focus group discussions (FGDs) among 3 groups of adult stakeholders of premature babies, including: (1) parents/family members of premature babies aged 6 weeks or less (3 FGDs); (2) healthcare providers of newborns (e.g., nurses; physicians; 1 FGD); (3) community opinion leaders and stakeholders (e.g., traditional birth attendants; pastors; village elders; 1 FGD). Content and thematic analyses of transcripts indicate that NeoWarm is acceptable and feasible in promoting facility-based kangaroo mother care in the Kenyan setting. Novel findings derived from respondents include (1) the ability of the device to potentially overcome several barriers to traditional kangaroo mother care methods and (2) user-driven encouragement to expand the use case of the device to potentially include community-based kangaroo mother care and neonatal transport. User design feedback obtained during the interviews informed several key design iterations for subsequent prototypes of the device.

Preclinical validation of NeoWarm, a low-cost infant warmer and carrier device, to ameliorate induced hypothermia in newborn piglets as models for human neonates.

Introduction: Approximately 1.5 million neonatal deaths occur among premature and small (low birthweight or small-for gestational age) neonates annually, with a disproportionate amount of this mortality occurring in low- and middle-income countries (LMICs). Hypothermia, the inability of newborns to regulate their body temperature, is common among prematurely born and small babies, and often underlies high rates of mortality in this population. In high-resource settings, incubators and radiant warmers are the gold standard for hypothermia, but this equipment is often scarce in LMICs. Kangaroo Mother Care/Skin-to-skin care (KMC/STS) is an evidence-based intervention that has been targeted for scale-up among premature and small neonates. However, KMC/STS requires hours of daily contact between a neonate and an able adult caregiver, leaving little time for the caregiver to care for themselves. To address this, we created a novel self-warming biomedical device, NeoWarm, to augment KMC/STS. The present study aimed to validate the safety and efficacy of NeoWarm. Methods: Sixteen, 0-to-5-day-old piglets were used as an animal model due to similarities in their thermoregulatory capabilities, circulatory systems, and approximate skin composition to human neonates. The piglets were placed in an engineered cooling box to drop their core temperature below 36.5°C, the World Health Organizations definition of hypothermia for human neonates. The piglets were then warmed in NeoWarm (n = 6) or placed in the ambient 17.8°C ± 0.6°C lab environment (n = 5) as a control to assess the efficacy of NeoWarm in regulating their core body temperature. Results: All 6 piglets placed in NeoWarm recovered from hypothermia, while none of the 5 piglets in the ambient environment recovered. The piglets warmed in NeoWarm reached a significantly higher core body temperature (39.2°C ± 0.4°C, n = 6) than the piglets that were warmed in the ambient environment (37.9°C ± 0.4°C, n = 5) (p < 0.001). No piglet in the NeoWarm group suffered signs of burns or skin abrasions. Discussion: Our results in this pilot study indicate that NeoWarm can safely and effectively warm hypothermic piglets to a normal core body temperature and, with additional validation, shows promise for potential use among human premature and small neonates.

Maternal age extremes and adverse pregnancy outcomes in low-resourced settings.

Introduction: Adolescent (<20 years) and advanced maternal age (>35 years) pregnancies carry adverse risks and warrant a critical review in low- and middle-income countries where the burden of adverse pregnancy outcomes is highest. Objective: To describe the prevalence and adverse pregnancy (maternal, perinatal, and neonatal) outcomes associated with extremes of maternal age across six countries. Patients and methods: We performed a historical cohort analysis on prospectively collected data from a population-based cohort study conducted in the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia between 2010 and 2020. We included pregnant women and their neonates. We describe the prevalence and adverse pregnancy outcomes associated with pregnancies in these maternal age groups (<20, 20-24, 25-29, 30-35, and >35 years). Relative risks and 95% confidence intervals of each adverse pregnancy outcome comparing each maternal age group to the reference group of 20-24 years were obtained by fitting a Poisson model adjusting for site, maternal age, parity, multiple gestations, maternal education, antenatal care, and delivery location. Analysis by region was also performed. Results: We analyzed 602,884 deliveries; 13% (78,584) were adolescents, and 5% (28,677) were advanced maternal age (AMA). The overall maternal mortality ratio (MMR) was 147 deaths per 100,000 live births and increased with advancing maternal age: 83 in the adolescent and 298 in the AMA group. The AMA groups had the highest MMR in all regions. Adolescent pregnancy was associated with an adjusted relative risk (aRR) of 1.07 (1.02-1.11) for perinatal mortality and 1.13 (1.06-1.19) for neonatal mortality. In contrast, AMA was associated with an aRR of 2.55 (1.81 to 3.59) for maternal mortality, 1.58 (1.49-1.67) for perinatal mortality, and 1.30 (1.20-1.41) for neonatal mortality, compared to pregnancy in women 20-24 years. This pattern was overall similar in all regions, even in the <18 and 18-19 age groups. Conclusion: The maternal mortality ratio in the LMICs assessed is high and increased with advancing maternal age groups. While less prevalent, AMA was associated with a higher risk of adverse maternal mortality and, like adolescence, was associated with adverse perinatal mortality with little regional variation.

Predictors of Plasmodium falciparum Infection in the First Trimester Among Nulliparous Women From Kenya, Zambia, and the Democratic Republic of the Congo.

BACKGROUND: Malaria can have deleterious effects early in pregnancy, during placentation. However, malaria testing and treatment are rarely initiated until the second trimester, leaving pregnancies unprotected in the first trimester. To inform potential early intervention approaches, we sought to identify clinical and demographic predictors of first-trimester malaria. METHODS: We prospectively recruited women from sites in the Democratic Republic of the Congo (DRC), Kenya, and Zambia who participated in the ASPIRIN (Aspirin Supplementation for Pregnancy Indicated risk Reduction In Nulliparas) trial. Nulliparous women were tested for first-trimester Plasmodium falciparum infection by quantitative polymerase chain reaction. We evaluated predictors using descriptive statistics. RESULTS: First-trimester malaria prevalence among 1513 nulliparous pregnant women was 6.3% (95% confidence interval [CI], 3.7%-8.8%] in the Zambian site, 37.8% (95% CI, 34.2%-41.5%) in the Kenyan site, and 62.9% (95% CI, 58.6%-67.2%) in the DRC site. First-trimester malaria was associated with shorter height and younger age in Kenyan women in site-stratified analyses, and with lower educational attainment in analyses combining all 3 sites. No other predictors were identified. CONCLUSIONS: First-trimester malaria prevalence varied by study site in sub-Saharan Africa. The absence of consistent predictors suggests that routine parasite screening in early pregnancy may be needed to mitigate first-trimester malaria in high-prevalence settings.

Regional trends in birth weight in low- and middle-income countries 2013-2018.

BACKGROUND: Birth weight (BW) is a strong predictor of neonatal outcomes. The purpose of this study was to compare BWs between global regions (south Asia, sub-Saharan Africa, Central America) prospectively and to determine if trends exist in BW over time using the population-based maternal and newborn registry (MNHR) of the Global Network for Women'sand Children's Health Research (Global Network). METHODS: The MNHR is a prospective observational population-based registryof six research sites participating in the Global Network (2013-2018), within five low- and middle-income countries (Kenya, Zambia, India, Pakistan, and Guatemala) in threeglobal regions (sub-Saharan Af rica, south Asia, Central America). The birth weights were obtained for all infants born during the study period. This was done either by abstracting from the infants' health facility records or from direct measurement by the registry staff for infants born at home. After controlling for demographic characteristics, mixed-effect regression models were utilized to examine regional differences in birth weights over time. RESULTS: The overall BW meanswere higher for the African sites (Zambia and Kenya), 3186 g (SD 463 g) in 2013 and 3149 g (SD 449 g) in 2018, ascompared to Asian sites (Belagavi and Nagpur, India and Pakistan), 2717 g (SD450 g) in 2013 and 2713 g (SD 452 g) in 2018. The Central American site (Guatemala) had a mean BW intermediate between the African and south Asian sites, 2928 g (SD 452) in 2013, and 2874 g (SD 448) in 2018. The low birth weight (LBW) incidence was highest in the south Asian sites (India and Pakistan) and lowest in the African sites (Kenya and Zambia). The size of regional differences varied somewhat over time with slight decreases in the gap in birth weights between the African and Asian sites and slight increases in the gap between the African and Central American sites. CONCLUSIONS: Overall, BWmeans by global region did not change significantly over the 5-year study period. From 2013 to 2018, infants enrolled at the African sites demonstrated the highest BW means overall across the entire study period, particularly as compared to Asian sites. The incidence of LBW was highest in the Asian sites (India and Pakistan) compared to the African and Central American sites. Trial registration The study is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.

Digital Health Innovations, Tools, and Resources to Support Helping Babies Survive Programs.

The Helping Babies Survive (HBS) initiative features a suite of evidence-based curricula and simulation-based training programs designed to provide health workers in low- and middle-income countries (LMICs) with the knowledge, skills, and competencies to prevent, recognize, and manage leading causes of newborn morbidity and mortality. Global scale-up of HBS initiatives has been rapid. As HBS initiatives rolled out across LMIC settings, numerous bottlenecks, gaps, and barriers to the effective, consistent dissemination and implementation of the programs, across both the pre- and in-service continuums, emerged. Within the first decade of expansive scale-up of HBS programs, mobile phone ownership and access to cellular networks have also concomitantly surged in LMICs. In this article, we describe a number of HBS digital health innovations and resources that have been developed from 2010 to 2020 to support education and training, data collection for monitoring and evaluation, clinical decision support, and quality improvement. Helping Babies Survive partners and stakeholders can potentially integrate the described digital tools with HBS dissemination and implementation efforts in a myriad of ways to support low-dose high-frequency skills practice, in-person refresher courses, continuing medical and nursing education, on-the-job training, or peer-to-peer learning, and strengthen data collection for key newborn care and quality improvement indicators and outcomes. Thoughtful integration of purpose-built digital health tools, innovations, and resources may assist HBS practitioners to more effectively disseminate and implement newborn care programs in LMICs, and facilitate progress toward the achievement of Sustainable Development Goal health goals, targets, and objectives.

NeoWarm: Kangaroo Mother Care with Continuous Temperature Tracking and Heating.

Premature births are highly prevalent; world-wide, one in every ten births is premature. A common complication of premature birth is the inability of the newborns to regulate their own body temperature (hypothermia). Kangaroo Mother Care (KMC) is an effective strategy to mitigate this problem but has challenges. Namely, KMC requires constant engagement from the caregiver in order to keep the baby warm and to monitor the baby's temperature every 4 hours. In this report we describe NeoWarm, a device designed to address these challenges via continuous integrated warming and automated temperature monitoring of the infant, both during KMC and when the caregiver takes a break. Pilot studies demonstrate the ability of the device to warm a simulated newborn from moderate hypothermia to ideal core temperatures within two hours.

A targeted systematic review of cost analyses for implementation of simulation-based education in healthcare.

Over the past two decades, there has been an increase in the use of simulation-based education for training healthcare providers in technical and non-technical skills. Simulation education and research programs have mostly focused on the impact on clinical knowledge and improvement of technical skills rather than on cost. To study and characterize existing evidence to inform multi-stakeholder investment decisions, we performed a systematic review of the literature on costs in simulation-based education in medicine in general and in neonatal resuscitation as a particular focus. We conducted a systematic literature search of the PubMed database using two targeted queries. The first searched for cost analyses of healthcare simulation-based education more broadly, and the second was more narrowly focused on cost analyses of neonatal resuscitation training. The more general query identified 47 qualified articles. The most common specialties for education interventions were surgery (51%); obstetrics, gynecology, or pediatrics (11%); medicine, nursing, or medical school (11%); and urology (9%), accounting for over 80% of articles. The neonatal resuscitation query identified five qualified articles. The two queries identified seven large-scale training implementation studies, one in the United States and six in low-income countries. There were two articles each from Tanzania and India and one article each from Zambia and Ghana. Methods, definitions, and reported estimates varied across articles, implying interpretation, comparison, and generalization of program effects are challenging. More work is needed to understand the costs, processes, and outcomes likely to make simulation-based education programs cost-effective and scalable. To optimize return on investments in training, assessing resource requirements, associated costs, and subsequent outcomes can inform stakeholders about the potential sustainability of SBE programs. Healthcare stakeholders and decision makers will benefit from more transparent, consistent, rigorous, and explicit assessments of simulation-based education program development and implementation costs in low- and high-income countries.

Evaluation of an educational program for essential newborn care in resource-limited settings: Essential Care for Every Baby.

BACKGROUND: Essential Care for Every Baby (ECEB) is an evidence-based educational program designed to increase cognitive knowledge and develop skills of health care professionals in essential newborn care in low-resource areas. The course focuses on the immediate care of the newborn after birth and during the first day or until discharge from the health facility. This study assessed the overall design of the course; the ability of facilitators to teach the course; and the knowledge and skills acquired by the learners. METHODS: Testing occurred at 2 global sites. Data from a facilitator evaluation survey, a learner satisfaction survey, a multiple choice question (MCQ) examination, performance on two objective structured clinical evaluations (OSCE), and pre- and post-course confidence assessments were analyzed using descriptive statistics. Pre-post course differences were examined. Comments on the evaluation form and post-course group discussions were analyzed to identify potential program improvements. RESULTS: Using ECEB course material, master trainers taught 12 facilitators in India and 11 in Kenya who subsequently taught 62 providers of newborn care in India and 64 in Kenya. Facilitators and learners were satisfied with their ability to teach and learn from the program. Confidence (3.5 to 5) and MCQ scores (India: pre 19.4, post 24.8; Kenya: pre 20.8, post 25.0) improved (p < 0.001). Most participants demonstrated satisfactory skills on the OSCEs. Qualitative data suggested the course was effective, but also identified areas for course improvement. These included additional time for hands-on practice, including practice in a clinical setting, the addition of video learning aids and the adaptation of content to conform to locally recommended practices. CONCLUSION: ECEB program was highly acceptable, demonstrated improved confidence, improved knowledge and developed skills. ECEB may improve newborn care in low resource settings if it is part of an overall implementation plan that addresses local needs and serves to further strengthen health systems.