Prioritization of maternal and newborn health policies and their implementation in the eastern conflict affected areas of the Democratic Republic of Congo: a political economy analysis.

BACKGROUND: Maternal and neonatal mortality remains a major concern in the Democratic Republic of Congo (DRC), and the country's protracted crisis context exacerbates the problem. This political economy analysis examines the maternal and newborn health (MNH) prioritization in the DRC, focussing specifically on the conflict-affected regions of North and South Kivu. The aim is to understand the factors that facilitate or hinder the prioritization of MNH policy development and implementation by the Congolese government and other key actors at national level and in the provinces of North and South Kivu. METHODS: Using a health policy triangle framework, data collection consisted of in-depth interviews with key actors at different levels of the health system, combined with a desk review. Qualitative data were analysed using inductive and then deductive approaches, exploring the content, process, actor dynamics, contextual factors and gender-related factors influencing MNH policy development and implementation. RESULTS: The study highlighted the challenges of prioritizing policies in the face of competing health and security emergencies, limited resources and governance issues. The universal health coverage policy seems to offer hope for improving access to MNH services. Results also revealed the importance of international partnerships and global financial mechanisms in the development of MNH strategies. They reveal huge gender disparities in the MNH sector at all levels, and the need to consider cultural factors that can positively or negatively impact the success of MNH policies in crisis zones. CONCLUSIONS: MNH is a high priority in DRC, yet implementation faces hurdles due to financial constraints, political influences, conflicts and gender disparities. Addressing these challenges requires tailored community-based strategies, political engagement, support for health personnel and empowerment of women in crisis areas for better MNH outcomes.

A feasibility study to assess non-clinical community health workers' capacity to use simplified protocols and tools to treat severe acute malnutrition in Niger state Nigeria.

BACKGROUND: Severe acute malnutrition (SAM) is a major determinant of childhood mortality and morbidity. Although integrated community case management (iCCM) of childhood illnesses is a strategy for increasing access to life-saving treatment, malnutrition is not properly addressed in the guidelines. This study aimed to determine whether non-clinical Community Health Workers (called Community-Oriented Resource Persons, CORPs) implementing iCCM could use simplified tools to treat uncomplicated SAM. METHODS: The study used a sequential multi-method design and was conducted between July 2017 and May 2018. Sixty CORPs already providing iCCM services were trained and deployed in their communities with the target of enrolling 290 SAM cases. Competency of CORPs to treat and the treatment outcomes of enrolled children were documented. SAM cases with MUAC of 9 cm to < 11.5 cm without medical complications were treated for up to 12 weeks. Full recovery was at MUAC≥12.5 cm for two consecutive weeks. Supervision and quantitative data capturing were done weekly while qualitative data were collected after the intervention. RESULTS: CORPs scored 93.1% on first assessment and increment of 0.11 (95% CI, 0.05-0.18) points per additional supervision conducted. The cure rate from SAM to full recovery, excluding referrals from the denominator in line with the standard for reporting SAM recovery rates, was 73.5% and the median length of treatment was 7 weeks. SAM cases enrolled at 9 cm to < 10.25 cm MUAC had 31% less likelihood of recovery compared to those enrolled at 10.25 cm to < 11.5 cm. CORPs were not burdened by the integration of SAM into iCCM and felt motivated by children's recovery. Operational challenges like bad terrains for supervision, supply chain management and referrals were reported by supervisors, while Government funding was identified as key for sustainability. CONCLUSION: The study demonstrated that with training and supportive supervision, CORPs in Nigeria can treat SAM among under-fives, and refer complicated cases using simplified protocols as part of an iCCM programme. This approach seemed acceptable to all stakeholders, however, the effect of the extra workload of integrating SAM into iCCM on the quality of care provided by the CORPs should be assessed further.

Community engagement strategy for increased uptake of routine immunization and select perinatal services in north-west Ethiopia: A descriptive analysis.

BACKGROUND: Routine immunization coverage has stagnated over the past decade and fallen short of WHO targets in Ethiopia. Community engagement strategies that reach beyond traditional health systems may reduce dropout and increase coverage. This evaluation assesses changes in immunization, postpartum family planning, and antenatal care coverage after implementation of an enhanced community engagement and defaulter tracing strategy, entitled "Fifth Child" project, across two districts in Benishangul-Gumuz Regional State (BGRS), Ethiopia. METHODS AND FINDINGS: A formative evaluation was conducted to examine the contribution of the strategy on immunization, postpartum family planning and antenatal care utilization in Assosa and Bambasi districts of BGRS. The quantitative findings are presented here. Routine and project-specific data were analyzed to assess changes in uptake of childhood vaccinations, postpartum family planning and antenatal care. Between January 2013 and December 2016, pentavalent-3 coverage increased from 63% to 84% in Assosa, and from 78% to 93% in Bambasi. Similarly, measles vaccine coverage increased from 77% to 81% in Assosa, and from 59% to 86% in Bambasi. Approximately 54% of all eligible infants across both woredas defaulted on scheduled vaccinations at least once during the period. Among defaulting children, 84% were identified and subsequently caught up on the vaccinations missed. Secondary outcomes of postpartum family planning and antenatal care also increased in both woredas. CONCLUSION: The "Fifth Child" project likely contributed to enhanced immunization performance and increased utilization of immunization and select perinatal health services in two woredas of BGRS. Further research is required in order to determine the impact of this community engagement strategy.

Adapting acute malnutrition treatment protocols in emergency contexts: a qualitative study of national decision-making.

BACKGROUND: Each year, an estimated 17 million children suffer from severe acute malnutrition (SAM) and 33 million from moderate acute malnutrition (MAM), with many of the most severe cases found in extremely food insecure contexts or conflict situations. Current global outpatient treatment protocols for uncomplicated SAM and MAM, adapted by most countries for use at national level, call for SAM and MAM to be managed separately, however global-level stakeholders have recently begun evaluating simplified and/or combined protocols managing acute malnutrition. METHODS: This study analyzes national policy discussions and decision-making around outpatient acute malnutrition treatment for uncomplicated cases in emergency situations in Niger, Nigeria, Somalia, and South Sudan. Data collection (March-July 2018) included semi-structured in-depth interviews with 50 respondents (N = 11-15 per country) from government, funding agencies, and implementing partners, as well as 11 global and regional stakeholders. We also conducted a document analysis (N = 10-15 per country and at global level) to situate debates and evaluate current policy. Data were analyzed iteratively using thematic content analysis. RESULTS: We find that while combined/simplified protocols for outpatient management of uncomplicated cases of acute malnutrition are being used in emergency situations in all four countries, there is widespread confusion about protocol terminology and content, stemming from a lack of coherence at the global level. As a result, national-level stakeholders express diverse, if overlapping, rationales for modifying current protocols, which vary given the intensity and scope of the emergency. Without specific global-level guidance, combined/simplified protocols are often used on an ad hoc basis, although the processes for triggering them were at least nominally controlled at the national level. Decisions about when and where to enact "exceptional" modifications to country protocols were often based on inconsistent determinations of what constitutes an "emergency." Respondents said more evidence is needed on both clinical and operational aspects of these protocols, and they awaited clear guidance from global norm-setting agencies. CONCLUSIONS: Based on these findings, global-level stakeholders should urgently improve coordination and communication around existing protocols. Standardized guidance based on the available evidence is required to clarify best practices for combined management of SAM and MAM, particularly in emergency contexts (which should be defined) and in situations of limited resources. Given the complexity of governance arrangements in conflict situations, both guidance and updates on research must be disseminated in a rational, systematic, and digestible way to the multiplicity of field actors.

Impact of Improved Biomass and Liquid Petroleum Gas Stoves on Birth Outcomes in Rural Nepal: Results of 2 Randomized Trials.

BACKGROUND: Few randomized trials have assessed the impact of reducing household air pollution from biomass stoves on adverse birth outcomes in low-income countries. METHODS: Two sequential trials were conducted in rural low-lying Nepal. Trial 1 was a cluster-randomized step-wedge trial comparing traditional biomass stoves and improved biomass stoves vented with a chimney. Trial 2 was a parallel household-randomized trial comparing vented biomass stoves and liquid petroleum gas (LPG) stoves with a year's supply of gas. Kitchen particulate matter of 2.5 µm or less (PM2.5) and carbon monoxide (CO) were assessed before and after stove installation. Prevalent and incident pregnancies were enrolled at baseline and throughout the trials. Birth anthropometry was compared across differing exposure times in pregnancy. RESULTS: In trial 1, the mean 20-hour kitchen PM2.5 concentration was reduced from 1380 µg/m3 to 936 µg/m3. Among infants born before the intervention, mean birth weight and gestational age were 2627 g (SD=443) and 38.8 weeks (SD=3.1), and 39% were low birth weight (LBW), 22% preterm, and 55% small for gestational age (SGA). Adverse birth outcomes were not significantly different with increasing exposure to improved stoves during pregnancy. In trial 2, the mean 20-hour PM2.5 concentration was 885 µg/m3 in households with vented biomass and 442 µg/m3 in those with LPG stoves. Mean birth weight was 2780 g (SD=427) and 2742 g (SD=431), among households with vented and LPG stoves, respectively. Respective percentages for LBW, SGA, and preterm were 23%, 13%, and 42% in the vented stove group and not statistically different from 31%, 17%, and 42% in the LPG group. CONCLUSIONS: Improved biomass or LPG stoves did not reduce adverse birth outcomes. PM2.5 and CO following improved stove installation remained well above the World Health Organization indoor air standard of 25 µg/m3 or intermediate air quality guideline of 37.5 µg/m3. Trials that lower indoor air pollution further are needed.

Severe acute malnutrition treatment delivered by low-literate community health workers in South Sudan: A prospective cohort study.

BACKGROUND: Community health worker (CHW)-delivered acute malnutrition treatment programs have been tested previously, but not with low-literate/-numerate cadres who operate in areas with the highest malnutrition burden and under-five mortality rates. The International Rescue Committee developed low-literacy-adapted tools and treatment protocol to enable low-literate/-numerate community-based distributors (CBD, the CHW cadre in South Sudan) to treat children for severe acute malnutrition (SAM) in their communities. METHODS: We conducted a prospective cohort study in March-September 2017, with 44 CBDs enrolling a total of 308 SAM children into treatment in their communities. Child treatment outcomes and length of treatment were documented. Uncomplicated SAM cases, defined for our study as children with mid-upper arm circumference (MUAC) of 90 to <115 mm or bilateral pitting oedema, without any medical complications, were treated for up to 16 weeks, and were considered fully recovered when they reached MUAC≥125 mm for two consecutive weeks. RESULTS: The recovery rate from the severe to the moderate acute malnutrition (MAM) cut-off of MUAC 115 mm was 91% (95% confidence interval (CI) = 88%-95%). The median length of treatment was five weeks. The recovery rate of children from SAM to full recovery was 75% (95% CI = 69%-81%). The median time to full recovery was eight weeks. The recovery rates reported here exclude children referred for care from the denominator, per standard reporting of acute malnutrition treatment recovery rates. When the data were compared against routine monitoring and evaluation data from nearby static clinics, children treated by CBDs appeared to have improved continuity of care and shorter time to recovery. CONCLUSIONS: The recovery rate for SAM children enrolled in acute malnutrition treatment by low-literate CBDs shows promise that deploying CHWs to treat SAM in areas with high prevalence and low treatment access may lead to higher recovery, better continuity of care in the transition between SAM and MAM, and shorter treatment time. Proper adaptations of tools and protocols can empower CHW cadres with low literacy and numeracy to successfully complete treatment steps. Key questions of scalability and cost-effectiveness remain.

Combined protocol for severe and moderate acute malnutrition in emergencies: Stakeholders perspectives in four countries.

Each year, acute malnutrition affects an estimated 52 million children under 5 years of age. Current global treatment protocols divide treatment of severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) despite malnutrition being a spectrum disease. A proposed Combined Protocol provides for (a) treatment of MAM and SAM at the same location; (b) diagnosis using middle-upper-arm circumference (MUAC) and oedema only; (c) treatment using a single product, ready-to-use-therapeutic food (RUTF), and (d) a simplified dosage schedule for RUTF. This study examines stakeholders' knowledge of and opinions on the Combined Protocol in Niger, Nigeria, Somalia, and South Sudan. Data collection included a document review followed by in-depth interviews with 50 respondents from government, implementing partners, and multilateral agencies, plus 11 global and regional stakeholders. Data were analysed iteratively using thematic content analysis. We find that acute malnutrition protocols in these countries have not been substantially modified to include components of the Combined Protocol, although aspects were accepted for use in emergencies. Respondents generally agreed that MAM and SAM treatment should be provided in the same location, however they said MUAC and oedema-only diagnosis, although more field-ready than other diagnostic measures, did not necessarily catch all malnourished children and may not be appropriate for "tall and slim" morphologies. Similarly, using only RUTF presented inherent logistical advantages, but respondents worried about pipeline issues. Respondents did not express strong opinions about simplified dosage schedules. Stakeholders interviewed indicated more evidence is needed on the operational implications and effectiveness of the Combined Protocol in different contexts.

Testing a simplified tool and training package to improve integrated Community Case Management in Tanganyika Province, Democratic Republic of Congo: a quasi-experimental study.

BACKGROUND: Integrated community case management (iCCM) is a strategy to train community health workers (relais communautaires or RECOs in French) in low-resource settings to provide treatment for uncomplicated malaria, pneumonia, and diarrhea for children 2-59 months of age. The package of Ministry of Public Health tools for RECOs in the Democratic Republic of Congo that was being used in 2013 included seven data collection tools and job aids which were redundant and difficult to use. As part of the WHO-supported iCCM program, the International Rescue Committee developed and evaluated a simplified set of pictorial tools and curriculum adapted for low-literate RECOs. METHODS: The revised training curriculum and tools were tested in a quasi-experimental study, with 74 RECOs enrolled in the control group and 78 RECOs in the intervention group. Three outcomes were assessed during the study period from Sept. 2015-July 2016: 1) quality of care, measured by direct observation and reexamination; 2) workload, measured as the time required for each assessment - including documentation; and 3) costs of rolling out each package. Logistic regression was used to calculate odds ratios for correct treatment by the intervention group compared to the control group, controlling for characteristics of the RECOs, the child, and the catchment area. RESULTS: Children seen by the RECOs in the intervention group had nearly three times higher odds of receiving correct treatment (adjusted odds ratio aOR = 2.9, 95% confidence interval CI = 1.3-6.3, P = 0.010). On average, the time spent by the intervention group was 10.6 minutes less (95% CI = 6.6-14.7, P < 0.001), representing 6.2 hours of time saved per month for a RECO seeing 35 children. The estimated cost savings amounts to over US$ 300 000 for a four-year program supporting 1500 RECOs. CONCLUSION: This study demonstrates that, at scale, simplified tools and a training package adapted for low-literate RECOs could substantially improve health outcomes for under-five children while reducing implementation costs and decreasing their workload. The training curriculum and simplified tools have been adopted nationally based on the results from this study.

Performance of low-literate community health workers treating severe acute malnutrition in South Sudan.

Previous studies have described barriers to access of childhood severe acute malnutrition (SAM) treatment, including long travel distances and high opportunity costs. To increase access in remote communities, the International Rescue Committee developed a simplified SAM treatment protocol and low-literacy-adapted tools for community-based distributors (CBD, the community health worker cadre in South Sudan) to deliver treatment in the community. A mixed-methods pilot study was conducted to assess whether low-literate CBDs can adhere to a simplified SAM treatment protocol and to examine the community acceptability of CBDs providing treatment. Fifty-seven CBDs were randomly selected to receive training. CBD performance was assessed immediately after training, and 44 CBDs whose performance score met a predetermined standard were deployed to test the delivery of SAM treatment in their communities. CBDs were observed and scored on their performance on a biweekly basis through the study. Immediately after training, 91% of the CBDs passed the predetermined 80% performance score cut-off, and 49% of the CBDs had perfect scores. During the study, 141 case management observations by supervisory staff were conducted, resulting in a mean score of 89.9% (95% CI: 86.4%-96.0%). For each performance supervision completed, the final performance score of the CBD rose by 2.0% (95% CI: 0.3%-3.7%), but no other CBD characteristic was associated with the final performance score. This study shows that low-literate CBDs in South Sudan were able to follow a simplified treatment protocol for uncomplicated SAM with high accuracy using low-literacy-adapted tools, showing promise for increasing access to acute malnutrition treatment in remote communities.

The resilience of integrated community case management in acute emergency: a case study from Unity State, South Sudan.

BACKGROUND: An active conflict in South Sudan in late 2013/early 2014 displaced approximately 2 million people over the course of several months. In May 2015, the International Rescue Committee and UNICEF conducted a mixed-methods case study of the impact of that acute emergency on integrated community case management (iCCM) of childhood illness programming in Payinjiar County, Unity State. The objective was to document the operations of an iCCM program during an acute crisis and to assess the program's ability to continue operations. RESULTS: This mixed-methods case study is comprised of semi-structured interviews and focus groups with key stakeholders such as policymakers, program implementers, community health workers (CHWs), and caregivers on their experience with iCCM programming during this time period. Routine program data were also analyzed to assess the effect of the crisis on key health indicators. FINDINGS: Internally displaced persons (IDPs) nearly doubled the population in Payinjiar. Some displaced CHWs continued to provide treatment in host communities when they were able to take supplies with them. Despite no formal community mobilization effort by the iCCM program, many IDPs identified CHWs in the communities they were displaced to and obtained care from them. Caregivers who had been internally displaced reported preferring care from CHWs especially in contrast to risking an insecure journey to health facilities. The total number of treatments provided per month by CHWs dropped during the acute crisis, but recovered to pre-crisis levels within six months. CHW supervisors attempted to continue supervision by utilizing their networks to track down displaced CHWs and assess the security situation prior to visits. The monthly supervision rate dropped to the lowest level of 77% in February 2014, but rebounded to 91% by August 2014. Several CHWs and community leaders qualitatively validated this claim of sustained supervision. CONCLUSIONS: CHWs, including those who were internally displaced, continued to provide treatment for childhood illnesses during an acute emergency, and service provision recovered faster to pre-crisis levels than the formal health sector. International donors and humanitarian actors should recognize iCCM as a potentially high-impact humanitarian response. Flexible funding from donors would enable further evidence generation on iCCM approaches and improvements that could both sustain and enhance programming in acute crisis.

Obstetric ultrasound use in low and middle income countries: a narrative review.

INTRODUCTION: Although growing, evidence on the impact, access, utility, effectiveness, and cost-benefit of obstetric ultrasound in resource-constrained settings is still somewhat limited. Hence, questions around the purpose and the intended benefit as well as potential challenges across various domains must be carefully reviewed prior to implementation and scale-up of obstetric ultrasound technology in low-and middle-income countries (LMICs). MAIN BODY: This narrative review discusses these issues for those trying to implement or scale-up ultrasound technology in LMICs. Issues addressed in this review include health personnel capacity, maintenance, cost, overuse and misuse of ultrasound, miscommunication between the providers and patients, patient diagnosis and care management, health outcomes, patient perceptions and concerns about fetal sex determination. CONCLUSION: As cost of obstetric ultrasound becomes more affordable in LMICs, it is essential to assess the benefits, trade-offs and potential drawbacks of large-scale implementation. Additionally, there is a need to more clearly identify the capabilities and the limitations of ultrasound, particularly within the context of limited training of providers, to ensure that the purpose for which an ultrasound is intended is actually feasible. We found evidence of obstetric uses of ultrasound improving patient management. However, there was evidence that ultrasound use is not associated with reducing maternal, perinatal or neonatal mortality. Patients in various studies reported to have both positive and negative perceptions and experiences related to ultrasound and lastly, illegal use of ultrasound for determining fetal sex was raised as a concern.

Measuring productivity and its relationship to community health worker performance in Uganda: a cross-sectional study.

BACKGROUND: To explore the nature of the relationship between and factors associated with productivity and performance among the community health volunteer (CHV) cadre (Village Health Teams, VHT) in Busia District, Eastern Uganda. The study was carried out to contribute to the global evidence on strategies to improve CHV productivity and performance. METHODS: This cross-sectional study was conducted with 140 VHT members as subjects and respondents. Data were collected between March and May 2013 on the performance and productivity of VHT members related to village visits and activities for saving maternal and child lives, as well as on independent factors that may be associated with these measures. Data were collected through direct observation of VHT activities, structured interviews with VHTs, and review of available records. The correlation between performance and productivity scores was estimated, and LASSO regression analyses were conducted to identify factors associated with these two scores independently. RESULTS: VHTs demonstrated wide variation in productivity measures, conducting a median of 13.2 service units in a three-month span (range: 2.0-114.9). Performance of the studied VHTs was generally high, with a median performance score (out of 100) of 96.4 (range: 50.9-100.0). We observed a weak correlation coefficient of 0.05 (p = 0.57) between productivity and performance scores. Older VHT age (≥50 years old, reference: <50 years old) (11.14, 95% CI: 3.26-19.01) and knowledge of danger signs (in units of ten-percentage points, 1.92, 95% CI: 0.01-3.83) were positively associated with productivity scores. Job satisfaction (1.46, 95% CI: 0.13-2.80) and knowledge of danger signs (in units of ten-percentage points, 1.02, 95% CI: 0.05-1.98) were positively associated with performance scores. CONCLUSIONS: Older VHT age and knowledge of danger signs were positively associated with productivity, and job satisfaction and knowledge of danger signs were positively associated with performance. No correlation was observed between productivity and performance scores. This lack of correlation suggests that interventions to improve CHV effectiveness may affect the two dimensions of effectiveness differently. We recommend that productivity and performance both be monitored to evaluate the overall impact of interventions to increase CHV effectiveness.

Perceptions, careseeking, and experiences pertaining to non-cephalic births in rural Sarlahi District, Nepal: a qualitative study.

BACKGROUND: In low-resource settings, a significant proportion of fetal, neonatal, and maternal deaths can be attributed to intrapartum-related complications. Certain risk factors, such as non-cephalic presentation, have a particularly high risk of complications. This qualitative study describes experiences around non-cephalic births and highlights existing perceptions and care-seeking behavior specific to non-cephalic presentation in rural Sarlahi District, Nepal. METHODS: We conducted in-depth interviews with 34 individuals, including women who recently gave birth to a non-cephalic infant and female decision-makers in their households. We also conducted two focus groups with mothers (have two or more children, with at least one child under age five) and two focus groups with grandmothers in the community. RESULTS: Several women described scenes of obstructed labor and practices like provision of unspecified injections early in labor to assist with the delivery. There were reports of arduous care-seeking processes from primary health centers to tertiary facilities, and mixed quality of care among home birth attendants and facility-based health workers respectively. Very few women were aware of the fetal presentation prior to delivery, and we identified no consistent understanding among participants of the risks of and care strategies for non-cephalic births. Risk perception around non-cephalic presentation varied widely. Some participants were acutely aware of potential dangers, while others had not heard of non-cephalic birth. Many interviewees said that the position in which a pregnant woman sleeps could impact the fetal position. Several participants had either taken or heard of medication intended to rotate the fetus into the correct position. CONCLUSIONS: Our findings suggest the mixed quality of and access to care associated with non-cephalic birth and a lack of consistent understanding of the risk of and care for non-cephalic births in rural Nepal. The high risk of the condition and the recommended tertiary care present a dilemma in low-resource settings; the logistical difficulties and the mixed quality of care make care-seeking and referral decisions complex. While public health stakeholders strive to improve the quality of and access to the formal health system, those players must also be sensitive to the potential negative implications of promoting institutional care-seeking.

Maternal Influenza Immunization and Prevention of Severe Clinical Pneumonia in Young Infants: Analysis of Randomized Controlled Trials Conducted in Nepal, Mali and South Africa.

BACKGROUND: To evaluate the effect of antenatal influenza vaccination on all-cause severe infant pneumonia, we performed pooled analysis of 3 randomized controlled trials conducted in Nepal, Mali and South Africa. METHODS: The trials were coordinated from the planning phase. The follow-up period was 0-6 months postpartum in Nepal and Mali and 0-24 weeks in South Africa. Pregnant women with gestational age 17-34 weeks in Nepal, ≥28 weeks in Mali and 20-36 weeks in South Africa were enrolled. Trivalent inactivated influenza vaccine (IIV) was compared with either saline placebo (Nepal and South Africa) or quadrivalent meningococcal conjugate vaccine (Mali). In South Africa, cases were hospitalized and were therefore considered to have severe pneumonia. In Nepal and Mali, severe infant pneumonia diagnosis was based on the WHO Integrated Management of Childhood Illness definition. RESULTS: A total of 10,002 mothers and 9801 live-born eligible infants were included in the present analysis. There was a 31% lower incidence rate of severe pneumonia in the IIV group compared with the control group in Nepal [incidence rate ratio (IRR): 0.69; 95% CI: 0.50-0.94; ]. In South Africa, there was a 43% lower incidence rate of severe pneumonia in the IIV group versus the control group (IRR: 0.57; 95% CI: 0.33-1.0). There was no difference in incidence rates between the IIV group and the control group in Mali. Overall, incidence rate of severe pneumonia was 20% lower in the IIV group compared with the control group (IRR: 0.80; 95% CI: 0.66-0.99; P = 0.04). Protection was highest in the high influenza circulation period (IRR: 0.44; 95% CI: 0.23-0.84). CONCLUSIONS: Maternal influenza immunization may reduce severe pneumonia episodes among infants-particularly those too young to be completely vaccinated against Streptococcus pneumoniae and influenza.

Impact of Timing of Influenza Vaccination in Pregnancy on Transplacental Antibody Transfer, Influenza Incidence, and Birth Outcomes: A Randomized Trial in Rural Nepal.

Background: Maternal influenza vaccination protects mothers and their infants in low resource settings, but little is known about whether the protection varies by gestational age at vaccination. Methods: Women of childbearing age in rural southern Nepal were surveilled for pregnancy, consented and randomized to receive maternal influenza vaccination or placebo, with randomization stratified on gestational age (17-25 or 26-34 weeks). Enrollment occurred in 2 annual cohorts, and vaccinations occurred from April 2011 through September 2013. Results: In sum, 3693 women consented and enrolled, resulting in 3646 live births. Although cord blood antibody titers and the rise in maternal titers were generally greater when women were vaccinated later in pregnancy, this was not statistically significant. The incidence risk ratio (IRR) for maternal influenza in pregnancy through 6 months postpartum was 0.62 (95% confidence interval [CI]: 0.35, 1.10) for those vaccinated 17-25 weeks gestation and 0.89 (95% CI: 0.39, 2.00) for those 26-34 weeks. Infant influenza IRRs were 0.73 (95% CI: 0.51, 1.05) for those whose mothers were vaccinated earlier in gestation, and 0.63 (95% CI: 0.37, 1.08) for those later. Relative risks (RR) for low birthweight were 0.83 (95% CI: 0.71, 0.98) and 0.90 (95% CI: 0.72, 1.12) for 17-25 and 26-34 weeks gestation at vaccination, respectively. IRRs did not differ for small-for-gestational age or preterm. No RRs were statistically different by timing of vaccine receipt. Conclusions: Vaccine efficacy did not vary by gestational age at vaccination, making maternal influenza immunization programs easier to implement where women present for care late in pregnancy. Clinical Trials Registration: NCT01034254.

Impact of maternal vaccination timing and influenza virus circulation on birth outcomes in rural Nepal.

OBJECTIVE: To describe the effect of maternal vaccination on birth outcomes in rural Nepal, modified by timing of vaccination in pregnancy and influenza virus activity. METHODS: A secondary analysis was conducted using data from two annual cohorts of a randomized controlled trial. A total of 3693 pregnant women from Sarlahi District were enrolled between April 25, 2011, and September 9, 2013. All participants were aged 15-40 years and received a trivalent inactivated influenza vaccine or placebo. The outcome measures included birth weight, pregnancy length, low birth weight (<2500 g), preterm birth, and small-for-gestational-age birth. RESULTS: Data were available on birth weight for 2741 births and on pregnancy length for 3623 births. Maternal vaccination increased mean birthweight by 42 g (95% confidence interval [CI] 8-76). The magnitude of this increase varied by season but was greatest among pregnancies with high influenza virus circulation during the third trimester. Birth weight increased by 111 g (95% CI -51 to 273) when 75%-100% of a pregnancy's third trimester had high influenza virus circulation versus 38 g (95% CI -6 to 81) when 0%-25% of a pregnancy's third trimester had high influenza virus circulation. However, these results were nonsignificant. CONCLUSION: Seasonal maternal influenza vaccination in rural Nepal increased birth weight; the magnitude appeared larger during periods of high influenza virus circulation. CLINICALTRIALS.GOV: NCT01034254.

Nutritional status of infants at six months of age following maternal influenza immunization: A randomized placebo-controlled trial in rural Nepal.

BACKGROUND: Maternal influenza vaccination has increased birth weight in two randomized trials in South Asia but the impact on infant growth is unknown. METHODS: A randomized placebo-controlled trial of year round maternal influenza immunization was conducted in two annual cohorts in Sarlahi District, southern plains of Nepal, from April 2011 through April 2014. Infants born to women enrolled in the trial had weight, length, and head circumference measured at birth and 6 months of age. The study was powered for the 3 primary trial outcomes but not for stunting and wasting at 6 months of age. RESULTS: 3693 women received placebo or influenza vaccine between 17 and 34 weeks gestation, resulting in 3646 live births. About 72% of infants who survived had weight and length measurements between 150 and 210 days of age. Prevalence of stunting (<-2 Z scores length-for-age) was 14.8% in the placebo and 13.6% in the vaccine groups, respectively. Stunting < -3 Z scores was 3.2% versus 2.0% in placebo versus vaccine groups (RR: 0.64 (95% CI: 0.39, 1.04)). Wasting (< -2 Z scores weight for length) was 10.3% versus 11.0% for placebo versus vaccine groups. Severe wasting (< -3 Z scores weight for length) was 3.8% for placebo versus 2.6% for vaccine (RR: 0.69 (95% CI: 0.44, 1.07)). The impact of flu vaccine on wasting was greater in cohort 2 than in cohort 1, (RR: 0.66 (0.44, 0.99) for any wasting), and RR: 0.45 (0.19, 1.09) for severe wasting. This corresponded to a larger impact on birth weight and a better vaccine match with circulating viruses in cohort 2. CONCLUSIONS: Although maternal immunization reduced low birth weight by 15%, only wasting at 6 months in the 2nd cohort was statistically significantly difference. However, the study was underpowered to detect reductions of public health importance. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01034254).

New Option in the Lives Saved Tool (LiST) Allows for the Conversion of Prevalence of Small-for-Gestational-Age and Preterm Births to Prevalence of Low Birth Weight.

Background: The Lives Saved Tool (LiST) is a software model that estimates the health impact of scaling up interventions on maternal and child health. One of the outputs of the model is an estimation of births by fetal size [appropriate-for-gestational-age (AGA) or small-for-gestational-age (SGA)] and by length of gestation (term or preterm), both of which influence birth weight. LiST uses prevalence estimates of births in these categories rather than of birth weight categories, because the causes and health consequences differ between SGA and preterm birth. The World Health Assembly nutrition plan, however, has set the prevalence of low birth weight (LBW) as a key indicator, with a specific goal of a 30% reduction in LBW prevalence by 2025.Objective: The objective of the study is to develop an algorithm that will allow LiST users to estimate changes in prevalence of LBW on the basis of changes in coverage of interventions and the resulting impact on prevalence estimates of SGA and preterm births.Methods: The study used 13 prospective cohort data sets from low- and middle-income countries (LMICs; 4 from sub-Saharan Africa, 5 from Asia, and 4 from Latin America), with reliable measures of gestational age and birth weight. By calculating the proportion of LBW births among SGA and preterm births in each data set and meta-analyzing those estimates, we calculated region-specific pooled rates of LBW among SGA and preterm births.Results: In Africa, 0.4% of term-AGA, 36.7% of term-SGA, 49.3% of preterm-AGA, and 100.0% of preterm-SGA births were LBW. In Asia, 1.0% of term-SGA, 47.0% of term-SGA, 36.7% of preterm-AGA, and 100.0% of preterm-SGA births were LBW. In Latin America, 0.4% of term-AGA, 34.4% of term-SGA, 32.3% of preterm-AGA, and 100.0% of preterm-SGA births were LBW.Conclusions: The simple conversion factor proposed here allows for the estimation of LBW within LiST for most LMICs. This will allow LiST users to approximate the impact of their health programs on LBW prevalence via the impact on SGA and preterm prevalence.