Robust adaptive deep brain stimulation control of in-silico non-stationary Parkinsonian neural oscillatory dynamics.

Objective. Closed-loop deep brain stimulation (DBS) is a promising therapy for Parkinson's disease (PD) that works by adjusting DBS patterns in real time from the guidance of feedback neural activity. Current closed-loop DBS mainly uses threshold-crossing on-off controllers or linear time-invariant (LTI) controllers to regulate the basal ganglia (BG) Parkinsonian beta band oscillation power. However, the critical cortex-BG-thalamus network dynamics underlying PD are nonlinear, non-stationary, and noisy, hindering accurate and robust control of Parkinsonian neural oscillatory dynamics.Approach. Here, we develop a new robust adaptive closed-loop DBS method for regulating the Parkinsonian beta oscillatory dynamics of the cortex-BG-thalamus network. We first build an adaptive state-space model to quantify the dynamic, nonlinear, and non-stationary neural activity. We then construct an adaptive estimator to track the nonlinearity and non-stationarity in real time. We next design a robust controller to automatically determine the DBS frequency based on the estimated Parkinsonian neural state while reducing the system's sensitivity to high-frequency noise. We adopt and tune a biophysical cortex-BG-thalamus network model as an in-silico simulation testbed to generate nonlinear and non-stationary Parkinsonian neural dynamics for evaluating DBS methods.Main results. We find that under different nonlinear and non-stationary neural dynamics, our robust adaptive DBS method achieved accurate regulation of the BG Parkinsonian beta band oscillation power with small control error, bias, and deviation. Moreover, the accurate regulation generalizes across different therapeutic targets and consistently outperforms current on-off and LTI DBS methods.Significance. These results have implications for future designs of closed-loop DBS systems to treat PD.

Pediatrics in Disasters: Evolution of a Hybrid Global Health Training Program During the COVID-19 Pandemic.

This report describes the Pediatrics in Disasters (PEDS) course during a novel hybrid in-person and virtual format due to the coronavirus disease 2019 pandemic. International and local faculty collaborated on 2021 precourse revisions and course facilitation for multinational in-person and virtual students. Student and facilitator 2021 surveys and 2019 to 2021 student feedback reported overall satisfaction with the course while suggesting needed improvements to maximize international and virtual student participation. The hybrid PEDS course structure successfully achieved course goals and incorporated international faculty. Lessons learned will guide future course revisions and fellow global health educators.

Effectiveness and cost-effectiveness of a group-based intervention to improve social-emotional development of young children in poverty-stricken areas: A cluster randomized controlled trial.

Background: Social-emotional ability is key to the well-being and future success of children; however, disparities in social-emotional development during an individual's early age can last a lifetime, which is particularly evident among children living in poverty-stricken areas. We aimed to determine the effectiveness, cost-effectiveness, and feasibility of a group-based intervention called the Care Group on social-emotional development for families living in poverty-stricken counties. Methods: We conducted a cluster (township) randomized controlled trial (C-RCT) every two weeks from July 2019 to June 2020 in a poverty-stricken area located in Shanxi, China. The outbreak of the COVID-19 pandemic suspended the implementation of the intervention in January 2020. The caregiver-child pairs in the intervention group participated in 12 group-based sessions with a structured curriculum and learning materials emphasizing nurturing ability and early childhood development. We applied a difference-in-differences (DID) model to estimate the intervention's impact. The analysis follows the intention-to-treat (ITT) principle. We used standard economic costing methods to estimate the cost of implementing the Care Group over the intervention period and adopted a societal perspective in the analysis. Results: We included 322 eligible caregiver-child pairs in the baseline (intervention n = 136, control n = 186) and surveyed 258 pairs in the endline (intervention n = 117, control n = 141). Compared with the control group, children in the intervention group had significantly fewer social-emotional problems (adjusted mean difference of Z score = -0.374, 95% CI = -0.718, -0.030, P = 0.033) six months after intervention. In the first year, the annual cost of implementing Care Group was US$146.10 per child, reduced to US$47.20 per child in the second year due to the exclusion of non-recurrent costs. The incremental cost-effectiveness ratio (ICER) was US$390.60. Conclusions: Care Group is an effective approach for promoting children's social-emotional development in poverty-stricken areas at an affordable cost and with high feasibility for scale-up. Considering the planned per capita health expenditure of the Chinese government for 2022, we believe that the presented evidence makes a solid scientific and financial case for integrating the Care Group intervention into the basic public health services (BPHS) package. Registration: Chinese Clinical Trials Registry (ChiCTR): ChiCTR1900022894.

Engage, Develop, Learn: a pilot randomized clinical trial to test if a mobile application can enhance home support for early cognitive development among children living in poverty.

Background: Mobile applications (apps) exist to promote early child development; however, few studies have examined use of these apps among low-income families. Our objectives were to measure engagement with the Engage, Develop, Learn (EDL) app and determine if it promoted engagement and behavior change among low-income caregivers. Methods: We conducted a pilot study among English and Spanish-speaking, low-income families with children ages 12 to 15 months who received either the EDL app or injury prevention text messages. Baseline data were collected and interventions delivered over two home visits. App engagement was measured using messages opened. Caregiver development-promoting behaviors were measured with STIMQ score changes from baseline to follow-up at child age 2 years. We conducted key informant interviews among families randomized to receive the EDL app to identify barriers and facilitators to app use. Results: A total of 100 caregivers were recruited at their children's preventive care visit with 50 randomized to receive the EDL app and 50 to receive the injury prevention text messages; however, only 25 in the development app and 34 in the injury prevention group completed both home visits. Follow-up data were collected from 14 in the development app group and 30 in the injury prevention group. Over 10 weeks, 24% (6/25) remained engaged with the development app. STIMQ scores did not differ between groups. Barriers included technical difficulties accessing the app, social stressors, and 'forgetting' to use it. Conclusions: Our pilot randomized trial of a child development app suggests that it may not be effective for promoting behavior change among low-income caregivers due to low engagement. Trial Registration: This pilot trial was registered with ClinicalTrials.gov (ID NCT02717390).

Investigating transmission of SARS-CoV-2 using novel face mask sampling: a protocol for an observational prospective study of index cases and their contacts in a congregate setting.

INTRODUCTION: This study aims to measure how transmission of SARS-CoV-2 occurs in communities and to identify conditions that lend to increased transmission focusing on congregate situations. We will measure SARS-CoV-2 in exhaled breath of asymptomatic and symptomatic persons using face mask sampling-a non-invasive method for SARS-CoV-2 detection in exhaled air. We aim to detect transmission clusters and identify risk factors for SARS-CoV-2 transmission in presymptomatic, asymptomatic and symptomatic individuals. METHODS AND ANALYSIS: In this observational prospective study with daily follow-up, index cases and their respective contacts are identified at each participating institution. Contact definitions are based on Centers for Disease Control and Prevention and local health department guidelines. Participants will wear masks with polyvinyl alcohol test strips adhered to the inside for 2 hours daily. The strips are applied to all masks used over at least 7 days. In addition, self-administered nasal swabs and (optional) finger prick blood samples are performed by participants. Samples are tested by standard PCR protocols and by novel antigen tests. ETHICS AND DISSEMINATION: This study was approved by the Colorado Multiple Institutional Review Board and the WHO Ethics Review Committee. From the data generated, we will analyse transmission clusters and risk factors for transmission of SARS-CoV-2 in congregate settings. The kinetics of asymptomatic transmission and the evaluation of non-invasive tools for detection of transmissibility are of crucial importance for the development of more targeted control interventions-and ultimately to assist with keeping congregate settings open that are essential for our social fabric. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (#NCT05145803).

Prevalence and Predictors of Low Birth Weight in a Rural Guatemalan Community.

BACKGROUND: The intention of our study was to establish the prevalence of low birth weight (LBW) as well as risk factors for LBW in infants born to a convenience sample of women enrolled in a home visitation maternal care program associated with the Center for Human Development in Southwest Trifinio, Guatemala. METHODS: This is an observational study analyzing self-reported data from a quality improvement database. We recorded the distribution of birthweights of infants born to women enrolled in Madres Sanas that delivered between October 2018 and December 2019. We grouped women by LBW (<2500g ) and adequate birthweight (≥2500g) infants, and performed bivariate comparisons using sociodemographic, obstetric, and intrapartum data. Using the independent variables shown to have an association with LBW, we then performed a multivariable analysis. RESULTS: There were 226 births among our program participants, 218 with recorded birthweights. The median birthweight was 3175g; 13.8% were LBW (<2500g), higher than Guatemala's average of 10.9%. Through our bivariate analysis, we determined women with LBW infants were younger, with a median age of 20.8 (IQR [17.8-23.7]) compared to a median age of 23.2 (IQR [19.8-27.3]) among women with infants ≥2500g (P=0.03). Women with LBW infants were also more likely to have fewer than 4 prenatal visits (33.3% vs 19.3%, P=0.04). CONCLUSION: Two significant findings emerged from our analysis: LBW infants were more commonly born to women who were younger in age and who had received fewer than 4 prenatal visits. These findings are consistent with existing literature on LBW in Latin America. Our study helps to strengthen the data around these associations and gives credence to programming and policy efforts in Latin America that support adequate prenatal care for all and youth education about reproductive health and contraceptive access.

The Addition of Traditional Birth Attendant Care to a Home-Based Skilled Nursing Program in Rural Guatemala: A Secondary Analysis from a Quality Improvement Database.

INTRODUCTION: The use of traditional birth attendants (TBAs) in low- and middle-income countries remains controversial. The aim of this secondary analysis was to observe factors associated with visiting a TBA in addition to a skilled nurse for antepartum care and how this additional care was associated with birth characteristics and outcomes. METHODS: The study included a convenience sample of women living in Southwestern Guatemala enrolled in a community nursing program between October 1, 2018, and December 3, 2019. This analysis describes the sociodemographic characteristics, antepartum care, birth outcomes, and postpartum behaviors of women who received antepartum care with skilled nurses only compared with women who received antepartum care with skilled nurses and a TBA. RESULTS: Of the 316 enrollees, 259 had given birth and completed their postpartum visit at the time of analysis. Three women were excluded because of missing data. The majority of women in the study sample reported visiting a TBA over the course of their pregnancies (80.9%). Women who saw a TBA in addition to the nurse were similar to the comparator sample except that they were almost 3 times more likely to have 8 or more prenatal contacts with the nurse. In separate multivariable logistic regression models adjusted for number of prenatal visits, women who saw a TBA in addition to nurses had a reduced likelihood of cesarean birth, increased likelihood of birth with a TBA, and increased likelihood of breastfeeding within one hour of birth compared with women who only received antenatal care from nurses. Patient-reported adverse outcomes were not included in the analysis because of low prevalence and concern about data quality and missing data. DISCUSSION: Among a convenience sample of women in the Trifinio community in rural Guatemala, a large proportion of women continued to seek the care of a TBA in pregnancy while using a skilled nursing program for antenatal care. Intentionally integrating the TBA into the maternity care workforce may be beneficial for improving pregnancy care quality measures.

Initial Contraceptive Choices of Women Enrolled in a Cluster-Randomized Trial in Southwest Trifinio, Guatemala.

INTRODUCTION: The aim of this analysis is to present initial contraceptive choices of women offered postpartum contraception in rural Guatemala. METHODS: We trained community nurses participating in the delivery of a home-based antepartum and postpartum care program in rural Guatemala in contraceptive implant placement and had them offer condoms, pills, an injection, or an implant at women's home-based 40-day postpartum visit in intervention clusters of a non-blinded, cluster-randomized trial. Women who had already started postpartum contraception or were over the age of 35 were excluded from participation. The primary outcome of the trial was contraceptive use at 3 months postpartum, so this initial analysis describes immediate preferences in the population. RESULTS: Of 208 women enrolled in the study, 108 were in intervention clusters and 100 lived in control clusters. In the intervention group, 32 women declined contraception, 36 women received the injectable, 30 women had an implant placed, 5 women started pills, 2 women chose condoms, and data on 3 women were missing. In the control clusters, 43 women were planning on the injectable, 11 planned on the implant, 10 did not want to start a method, 5 planned on sterilization, 2 aimed for natural family planning, 2 wanted a copper IUD, 1 woman wanted condoms, 18 did not know, and data on 8 women were missing. DISCUSSION: The contraceptive implant, which was not previously available in this community, had high uptake at 27.8% in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391 Protocol: https://doi.org/10.1186/s13063-019-3735-3.

Delivery of home-based post-partum contraception in rural Guatemalan women: feasibility, recruitment and retention in a cluster-randomized trial.

BACKGROUND: Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial. METHODS: In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. RESULTS: Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%. CONCLUSIONS: Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.

Identifying Prevalence and Risk Factors for Intimate Partner Violence in Pregnant Women in Rural Guatemala.

BACKGROUND: Victims of intimate partner violence (IPV) during pregnancy experience significant physical and mental health consequences and adverse birth outcomes. Our objective was to describe the prevalence of IPV, and risk factors associated with IPV in pregnant, rural Guatemalan women. METHODS: This retrospective cohort study was completed using quality improvement data gathered during routine prenatal health visits to women of Trifinio, Guatemala, by the Madres Sanas maternal health program from 2018 through 2020. Chi-square and t-tests were used to determine if there were differences in characteristics between women who self-reported experiencing IPV and those who did not. If differences occurred (p < 0.2), those covariates were included in a multivariable logistic regression to determine sociodemographic risk associated with IPV. RESULTS: 583 women were enrolled with Madres Sanas between October 10, 2018, and October 1, 2020, and reported on IPV. Nineteen (3.26%) women reported experiencing IPV. The highest prevalence of IPV (7.6%) occurred in the sub-group of women who experienced food insecurity during the past year. The sole covariate of all sociodemographic and health characteristics which differed significantly between women who reported experiencing and not experiencing IPV was food insecurity. A regression model found that those who had worried about ability to buy food in the past year had a 3.19-fold increase in the odds that they experienced IPV (95% CI 1.072, 9.486, p-value 0.037). CONCLUSION: Among this convenience sample of women, the prevalence of IPV was 3.26%. Food insecurity was associated with increased odds of experiencing IPV, highlighting an opportunity for interventions.

Characteristics Associated with Choosing Long-Acting Reversible Contraception in Rural Guatemala: A Secondary Analysis of a Cluster-Randomized Trial.

DESIGN: We conducted a secondary analysis of a cluster-randomized trial to observe characteristics associated with women who chose to use long-acting reversible contraceptives (LARC) compared to those who chose a short-acting method 12 months after enrollment. METHODS: The trial studied four control and four intervention clusters where the intervention clusters were offered contraception at their 40-day routine postpartum visit; control clusters received standard care, which included comprehensive postpartum contraceptive counseling. Women were followed through twelve months postpartum. RESULTS: The study enrolled 208 women; 94 (87.0%) were in the intervention group and 91 (91.0%) were in the control group. At twelve months, with 130 (70.3%) women using contraception at that time. 94 women (50.8%) were using a short acting method compared to 33 (17.9%) who chose a long-acting method, irrespective of cluster. In mixed effect regression modeling adjusted for cluster, characteristics associated with a reduced likelihood of choosing long-acting contraception in multivariate modeling included age (aRR 0.98 [0.96,0.99], p = 0.008) and any education (compared to no education; aRR 0.76 [0.60,0.95], p = 0.02). Women who were sexually active by their enrollment visit (40 days postpartum) were 30% more likely to opt for a long-acting method (aRR 1.30 [1.03,1.63], p = 0.03). CONCLUSION: Older and more educated women were less likely to be using LARC a year after enrollment, while women with a history of early postpartum sexual activity were more likely to choose LARC.

Twelve-Month outcomes of a Cluster-Randomized Trial of Home-Based Postpartum Contraceptive Delivery in Southwest Trifinio, Guatemala.

DESIGN: We executed a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with three and 12-month contraceptive utilization, satisfaction, and pregnancy rates. METHODS: Eight clusters were randomized to receive either the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit in addition to routine care, or routine care alone, which included comprehensive contraceptive counseling throughout antepartum care. RESULTS: 208 women were enrolled in the study, 108 in the intervention clusters and 100 in control clusters. 94 (87.0%) women in the intervention group and 91 (91%) of women in control clusters were evaluated 12 months post-enrollment. Likelihood of using contraception at that time was borderline increased in intervention clusters (RR 1.1 [1.0,1.3], p = 0.05) with an increased likelihood of long-acting contraceptive use (the implant; RR 1.6 [1.3,1.9], p < 0.001). Pregnancy rates were also borderline reduced in the intervention clusters (RR 1.0 [1.0,1.1], p = 0.07). There was no difference in satisfaction of women with contraceptive use between arms with about 95% of women very satisfied or a little satisfied in each arm. Continuation rates at twelve months of contraceptives in the intervention group were 0.0% for condom users, 80.0% for contraceptive pill users, 57% for injectable users, and 83% for implant users. Most women who discontinued their initial method chose a more long-term or permanent method. There was a trend toward a significant association with reduced short interval pregnancy. CONCLUSION: Our study had a borderline increase in overall use of contraception by 12 months, did have an increased likelihood of long-acting contraceptive use of the implant by 12 months, and resulted in a trend toward reduced short interval pregnancy in the intervention clusters as compared to control clusters.

Seasonal Influenza Prevention and Control Progress in Latin America and the Caribbean in the Context of the Global Influenza Strategy and the COVID-19 Pandemic.

Each year in Latin America and the Caribbean, seasonal influenza is associated with an estimated 36,500 respiratory deaths and 400,000 hospitalizations. Since the 2009 influenza A(H1N1) pandemic, the Region has made significant advances in the prevention and control of seasonal influenza, including improved surveillance systems, burden estimates, and vaccination of at-risk groups. The Global Influenza Strategy 2019-2030 provides a framework to strengthen these advances. Against the backdrop of this new framework, the University of Colorado convened in October 2020 its Immunization Advisory Group of Experts to review and discuss current surveillance, prevention, and control strategies for seasonal influenza in Latin America and the Caribbean, also in the context of the COVID-19 pandemic. This review identified five areas for action and made recommendations specific to each area. The Region should continue its efforts to strengthen surveillance and impact evaluations. Existing data on disease burden, seasonality patterns, and vaccination effectiveness should be used to inform decision-making at the country level as well as advocacy efforts for programmatic resources. Regional and country strategic plans should be prepared and include specific targets for 2030. Existing investments in influenza prevention and control, including for immunization programs, should be optimized. Finally, regional partnerships, such as the regional networks for syndromic surveillance and vaccine effectiveness evaluation (SARInet and REVELAC-i), should continue to play a critical role in continuous learning and standardization by sharing experiences and best practices among countries.

A cumulative risk index for use in the medical home.

BACKGROUND AND OBJECTIVE: Previous studies have described the effect of sociodemographic factors on early development. We describe development of a simple cumulative risk index (CRI) based on four sociodemographic factors and explore the concurrent and predictive relationship of this index to a measure of the cognitive home environment in early childhood and to later school functioning. METHODS: This was a secondary data analysis of children from an urban pediatrics clinic. Baseline data were collected at 10-23 months (n = 324) with primary follow-up 6 months later at 18-35 months (n = 179) and secondary follow-up at 8-10 years (n = 68). A CRI score was derived at baseline using maternal education, marital status, race/ethnicity and child insurance. Baseline and primary follow-up included three subscales of the STIMQ, a measure of the cognitive home environment. Effectiveness of CRI was examined using analysis of variance (ANOVA) with linear contrasts. Chi-square examined differences in school function between children from CRI high-risk (CRI 3-4) and low-risk (CRI 0-2) families. RESULTS: CRI had a negative impact in early childhood on STIMQ subscale scores (p < 0.007-0.05) that increased as the number of risk factors increased (p < 0.05). Significantly more children from high-risk families (CRI 3-4) were rated as having poor school performance than children from low-risk families (CRI 0-2) (p < 0.05). CONCLUSIONS: We showed that a practice-friendly CRI, based on characteristics typically available in the medical record, could help identify families less likely to support development concurrently at 1 year of age and predictively at 2-3 years. School functioning at 8 to 10 years was also significantly better in children with a low CRI at 1 year. The CRI could be a useful tool for both clinicians and researchers needing a simple tool for risk assessment.

Group-based intervention to improve developmental status among children age 6-18 months in rural Shanxi province, China: a study protocol for a cluster randomised controlled trial.

INTRODUCTION: Early childhood development (ECD) is a critical component for building the foundation of future physical and emotional health and subsequent academic success. The quality of the home environment to promote development is an important factor in ECD. Since large rural-urban disparities in the home environment exist in China, there is a critical need to develop and evaluate interventions to promote ECD in rural areas. Individual center-based or home-based interventions dominate the current ECD programmes in rural China. However, group-based interventions offer potential advantages in terms of both effectiveness and cost. Thus, we aim to: (1) evaluate the effectiveness of an integrated group-based intervention, the Care Group Intervention, in enhancing ECD among children age 6-18 months and (2) conduct a cost-effectiveness analysis. METHODS AND ANALYSIS: The Care Group Intervention uses a cluster (by township) randomised controlled trial conducted in Fenxi county, Shanxi province, China, from July 2019, for 1 year. The intervention focuses on five key components of nurturing care including good health, adequate nutrition, responsive caregiving, security and safety, and opportunities for early learning. The intervention comprises small groups of 3-10 children within a certain age range and their primary caregivers that are led by well-trained local facilitators. Outcomes includes infants' developmental quotient (Bayley Scales of Infant Development III, Ages & Stages Questionnaire: Social-Emotional, second edition); anaemia (HemoCue Hb 301+); nurturing environment (Infant/Toddler Home Observation for Measurement of the Environment), parent-child interaction (Teaching Scale) and caregiver depression (Center for Epidemiological Studies Depression). Cost data are collected throughout the entire study to carry out a cost-effectiveness analysis. ETHICS AND DISSEMINATION: This study was approved by the Ethical Committee of Capital Institute of Pediatrics, Beijing, China on 10 July 2018 (SHERLL2018014). Findings and results from this project will be disseminated via publications and presentations. TRIAL REGISTRATION NUMBER: Chinese Clinical Trials Registry: ChiCTR1900022894. Registered on 30 April 2019.

Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

DESIGN: This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment. METHODS: In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS: Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION: Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION: clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

COVID-19 and newborn health: systematic review.

OBJECTIVE: To describe perinatal and neonatal outcomes in newborns exposed to SARS-CoV-2. METHODS: A systematic review was conducted by searching PubMed Central, LILACS, and Google Scholar using the keywords 'covid ' AND 'newborn' OR 'child' OR 'infant,' on 18 March 2020, and again on 17 April 2020. One researcher conducted the search and extracted data on demographics, maternal outcomes, diagnostic tests, imaging, and neonatal outcomes. RESULTS: Of 256 publications identified, 20 met inclusion criteria and comprised neonatal outcome data for 222 newborns whose mothers were suspected or confirmed to be SARS-CoV-2 positive perinatally (17 studies) or of newborns referred to hospital with infection/pneumonia (3 studies). Most (12 studies) were case-series reports; all were from China, except three (Australia, Iran, and Spain). Of the 222 newborns, 13 were reported as positive for SARS-CoV-2; most of the studies reported no or mild symptoms and no adverse perinatal outcomes. Two papers among those from newborns who tested positive reported moderate or severe clinical characteristics. Five studies using data on umbilical cord blood, placenta, and/or amniotic fluid reported no positive results. Nine studies reported radiographic imaging, including 5 with images of pneumonia, increased lung marking, thickened texture, or high-density nodular shadow. Minor, non-specific changes in biochemical variables were reported. Studies that tested breast milk reported negative SARS-CoV-2 results. CONCLUSIONS: Given the paucity of studies at this time, vertical transmission cannot be confirmed or denied. Current literature does not support abstaining from breastfeeding nor separating mothers and newborns. Further evidence and data collection networks, particularly in the Americas, are needed for establishing definitive guidelines and recommendations.