Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial.
ABSTRACT: Newborn health is a key issue in addressing the survival of children under five years old, particularly in low and middle income countries, and the evidence base for newborn health interventions continues to evolve. Over the last decade, maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia, but newborn health has lagged behind. Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis. While initiatives are being implemented to address some causes of newborn illness (related to pre-term birth and asphyxia), a country-level approach to reducing infections has not been formulated. The Newborn Infection Control and Care Initiative (NICCI) is a community and health facility linked intervention to improve health outcomes for newborns.The present study applies a cluster randomized trial, using a stepped wedge design, to assess the impact of a package intervention on newborn health. The intervention components include addressing infection control in the perinatal period in health facilities, promoting infection prevention and control practices in health center and home environments, and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities, by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn's life.The NICCI trial is designed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care. Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country.This trial was registered with Clinicaltrials.gov (identifier: NCT02271737) on 5 October 2014.
Project description:BACKGROUND:Newborn mortality in Cambodia remains high, with sepsis and complications of delayed care-seeking important contributing factors. Intervention study objectives were to improve infection control behavior by staff in health centers; improve referral of sick newborns; increase recognition of danger signs, and prompt care-seeking at an appropriate health facility; and appropriate referral for sick newborns by mothers and families of newborn infants. METHODS:The stepped-wedge cluster-randomized controlled trial took place in rural Cambodia from February 2015 to November 2016. Sixteen clusters consisted of public health center catchment areas serving the community. The intervention included health center staff training and home visits to mothers by community health volunteers within 24 hours of birth and on days 3 and 7 after delivery, including assessment of newborns for danger signs and counselling mothers. The trial participants included women who had recently delivered a newborn who were visited in their homes in the first week, as well as health center staff and community volunteers who were trained in newborn care. Women in their last trimester of pregnancy greater than 18 years of age were recruited and were blinded to their group assignment. Mothers and caregivers (2494) received counseling on handwashing practices, breastfeeding, newborn danger signs, and prompt, appropriate referral to facilities. RESULTS:Health center staff in the intervention group had increased likelihood of hand washing at recommended key moments when compared with the control group, increased knowledge of danger signs, and higher recall of at least three hygiene messages. Of mother/caregiver participants at 14 days after delivery, women in the intervention group were much more likely to know at least three danger signs and to have received messages on care-seeking compared with controls. CONCLUSIONS:The intervention improved factors understood to be associated with newborn survival and health. Well-designed training, followed by regular supervision, enhanced the knowledge and self-reported behavior of health staff and health volunteers, as well as mothers' own knowledge of newborn danger signs. However, further improvement in newborn care, including care-seeking for illness and handwashing among mothers and families, will require additional involvement from broader stakeholders in the community.
Project description:More than 20 million babies are born with low birthweight annually. Small newborns have an increased risk for mortality, growth failure, and other adverse outcomes. Numerous antenatal risk factors for small newborn size have been identified, but individual interventions addressing them have not markedly improved the health outcomes of interest. We tested a hypothesis that in low-income settings, newborn size is influenced jointly by multiple maternal exposures and characterized pathways associating these exposures with newborn size. This was a prospective cohort study of pregnant women and their offspring nested in an intervention trial in rural Malawi. We collected information on maternal and placental characteristics and used regression analyses, structural equation modelling, and random forest models to build pathway maps for direct and indirect associations between these characteristics and newborn weight-for-age Z-score and length-for-age Z-score. We used multiple imputation to infer values for any missing data. Among 1,179 pregnant women and their babies, newborn weight-for-age Z-score was directly predicted by maternal primiparity, body mass index, and plasma alpha-1-acid glycoprotein concentration before 20 weeks of gestation, gestational weight gain, duration of pregnancy, placental weight, and newborn length-for-age Z-score (p < .05). The latter 5 variables were interconnected and were predicted by several more distal determinants. In low-income conditions like rural Malawi, maternal infections, inflammation, nutrition, and certain constitutional factors jointly influence newborn size. Because of this complex network, comprehensive interventions that concurrently address multiple adverse exposures are more likely to increase mean newborn size than focused interventions targeting only maternal nutrition or specific infections.
Project description:INTRODUCTION:There is a set of globally accepted and nationally adapted signal functions for categorising health facilities for maternal services. Newborn resuscitation is the only newborn intervention which is included in the WHO recommended list of emergency obstetric care signal functions. This is not enough to comprehensively assess the readiness of a health facility for providing newborn services. In order to address the major causes of newborn death, the Government of Bangladesh has prioritised a set of newborn interventions for national scale-up, the majority of which are facility-based. Effective delivery of these interventions depends on a core set of functions (skills and services). However, there is no standardised and approved set of newborn signal functions (NSFs) based on which the service availability and readiness of a health facility can be assessed for providing newborn services. Thus, this study will be the first of its kind to identify such NSFs. These NSFs can categorise health facilities and assist policymakers and health managers to appropriately plan and adequately monitor the progress and performance of health facilities delivering newborn healthcare. METHODS AND ANALYSIS:We will adopt the Delphi technique of consensus building for identification of NSFs and 1-2 indicator for each function while employing expert consultation from relevant experts in Bangladesh. Based on the identified NSFs and signal function indicators, the existing health facility assessment (HFA) tools will be updated, and an HFA survey will be conducted to assess service availability and readiness of public health facilities in relation to the new NSFs. Descriptive statistics (proportion) with a 95% CI will be used to report the level of service availability and readiness of public facilities regarding NSFs. ETHICS AND DISSEMINATION:Ethical approval was obtained from Research Review and Ethical Review Committee of icddr, b (PR-17089). Results will be disseminated through meetings, seminars, conference presentations and international peer-review journal articles.
Project description:BACKGROUND:Increasingly, neonatal mortality is concentrated in settings of conflict and political instability. To promote evidence-based practices, an interagency collaboration developed the Newborn Health in Humanitarian Settings: Field Guide. The essential newborn care component of the Field Guide was operationalized with the use of an intervention package encompassing the training of health workers, newborn kit provisions and the installation of a newborn register. METHODS:We conducted a quasi-experimental prepost study to test the effectiveness of the intervention package on the composite outcome of essential newborn care from August 2016 to December 2018 in Bossaso, Somalia. Data from the observation of essential newborn care practices, evaluation of providers' knowledge and skills, postnatal interviews, and qualitative information were analyzed. Differences in two-proportion z-tests were used to estimate change in essential newborn care practices. A generalized estimating equation was applied to account for clustering of practice at the health facility level. RESULTS:Among the 690 pregnant women in labor who sought care at the health facilities, 89.9% (n?=?620) were eligible for inclusion, 84.7% (n?=?525) were enrolled, and newborn outcomes were ascertained in 79.8% (n?=?419). Providers' knowledge improved from pre to posttraining, with a mean difference in score of +?11.9% (95% CI: 7.2, 16.6, p-value <?0.001) and from posttraining to 18-months after training with a mean difference of +?10.9% (95% CI: 4.7, 17.0, p-value <?0.001). The proportion of newborns who received two or more essential newborn care practices (skin-to-skin contact, early breastfeeding, and dry cord care) improved from 19.9% (95% CI: 4.9, 39.7) to 94.7% (95% CI: 87.7, 100.0). In the adjusted model that accounted for clustering at health facilities, the odds of receiving two or more essential newborn practices was 64.5 (95% CI: 15.8, 262.6, p-value <?0.001) postintervention compared to preintervention. Predischarge education offered to mothers on breastfeeding 16.5% (95% CI: 11.8, 21.1) vs 44.2% (95% CI: 38.2, 50.3) and newborn illness danger signs 9.1% (95% CI: 5.4, 12.7) vs 5.0% (95% CI: 2.4, 7.7) remained suboptimal. CONCLUSIONS:The intervention package was feasible and effective in improving essential newborn care. Knowledge and skills gained after training were mostly retained at the 18-month follow-up.
Project description:Uganda's Ministry of Health, together with partners, has introduced integrated community case management (iCCM) for children under 5 years. We assessed how the iCCM program addresses newborn care in three midwestern districts through document reviews, structured interviews, and focus group discussions with village health team (VHT) members trained in iCCM, caregivers, and other stakeholders. Almost all VHT members reported that they refer sick newborns to facilities and could identify at least three newborn danger signs. However, they did not identify the most important clinical indicators of severe illness. The extent of compliance with newborn referral and quality of care for newborns at facilities is not clear. Overall iCCM is perceived as beneficial, but caregivers, VHTs, and health workers want to do more for sick babies at facilities and in communities. Additional research is needed to assess the ability of VHTs to identify newborn danger signs, referral compliance, and quality of newborn treatment at facilities.
Project description:OBJECTIVES:The aim of this study was to describe potential factors contributing to neonatal mortality in Takeo, Cambodia through assessment of verbal autopsies collected following newborn deaths in the community. The mortality review was nested within a trial of a behavioral intervention to improve newborn survival, and was conducted after the close of the trial, within the study setting. The World Health Organization standardized definition of neonatal mortality was employed, and two pediatricians independently reviewed data collected from each event to assign a cause of death. RESULTS:Thirteen newborn deaths of infants born in health facilities participating in a community based, behavioral intervention were reported during February 2015-November 2016. Ten deaths (76.92%) were early neonatal deaths, two (15.38%) were late neonatal deaths, and one was a stillbirth. Five out of 13 deaths (38.46%) occurred within the first day of life. The largest single contributor to mortality was neonatal sepsis; six of 13 deaths (46.15%) were attributed to some form of sepsis. Twenty-three percent of deaths were attributed to asphyxia. The study highlights the continuing need to improve quality of care and infection prevention and control, and to fully address causes of sepsis, in order to effectively reduce mortality in the newborn period.
Project description:<h4>Objective</h4>To assess readiness and quality of essential newborn care and neonatal resuscitation practices in public health facilities in Afghanistan.<h4>Design</h4>Cross-sectional assessment.<h4>Setting</h4>226 public health facilities in Afghanistan, including 77 public health facilities with at least five births per day (high-volume facilities) and 149 of 1736 public health facilities with fewer than five births per day (low-volume facilities).<h4>Participants</h4>Managers of 226 public health facilities, 734 skilled birth attendants (SBAs) working at these facilities, and 643 women and their newborns observed during childbirth at 77 high-volume health facilities.<h4>Outcome measures</h4>Availability of knowledgeable SBAs, availability of supplies and compliance with global guidelines for essential newborn care and neonatal resuscitation practices.<h4>Results</h4>At high-volume facilities, 569/636 (87.9%) of babies were dried immediately after birth, 313/636 (49.2%) were placed in skin-to-skin contact with their mother and 581/636 (89.7%) had their umbilical cord cut with a sterile blade or scissors. A total of 87 newborn resuscitation attempts were observed. Twenty-four of the 87 (27.5%) began to breath or cry after simply clearing the airway or on stimulation. In the remaining 63 (72.5%) cases, a healthcare worker began resuscitation with a bag and mask; however, only 54 (62%) used a correct size of mask and three babies died as their resuscitation with bag and mask was unsuccessful.<h4>Conclusions</h4>The study indicates room for improvement of the quality of neonatal resuscitation practices at public health facilities in Afghanistan, requiring only strengthening of the current best practices in newborn care. Certain basic and effective aspects of essential newborn care that can be improved on with little additional resources were also missing, such as skin-to-skin contact of the babies with their mother. Improvement of compliance with the standard newborn care practices must be ensured to reduce preventable newborn mortality and morbidity in Afghanistan.
Project description:The Every Newborn Action Plan (ENAP) and Ending Preventable Maternal Mortality targets cannot be achieved without high quality, equitable coverage of interventions at and around the time of birth. This paper provides an overview of the methodology and findings of a nine paper series of in-depth analyses which focus on the specific challenges to scaling up high-impact interventions and improving quality of care for mothers and newborns around the time of birth, including babies born small and sick.The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the ENAP process. Country workshops engaged technical experts to complete a tool designed to synthesise "bottlenecks" hindering the scale up of maternal-newborn intervention packages across seven health system building blocks. We used quantitative and qualitative methods and literature review to analyse the data and present priority actions relevant to different health system building blocks for skilled birth attendance, emergency obstetric care, antenatal corticosteroids (ACS), basic newborn care, kangaroo mother care (KMC), treatment of neonatal infections and inpatient care of small and sick newborns.The 12 countries included in our analysis account for the majority of global maternal (48%) and newborn (58%) deaths and stillbirths (57%). Our findings confirm previously published results that the interventions with the most perceived bottlenecks are facility-based where rapid emergency care is needed, notably inpatient care of small and sick newborns, ACS, treatment of neonatal infections and KMC. Health systems building blocks with the highest rated bottlenecks varied for different interventions. Attention needs to be paid to the context specific bottlenecks for each intervention to scale up quality care. Crosscutting findings on health information gaps inform two final papers on a roadmap for improvement of coverage data for newborns and indicate the need for leadership for effective audit systems.Achieving the Sustainable Development Goal targets for ending preventable mortality and provision of universal health coverage will require large-scale approaches to improving quality of care. These analyses inform the development of systematic, targeted approaches to strengthening of health systems, with a focus on overcoming specific bottlenecks for the highest impact interventions.
Project description:<h4>Background</h4>This study explored the role of health facility availability as it relates to maternal and newborn PNC use in rural Malawi.<h4>Methods</h4>Malawi Demographic and Health Survey (MDHS) 2015-16 data, MDHS 2015-16 household cluster GPS data, Malawi Service Provision Assessment (MSPA) 2013-14 data and MSPA 2013-14 facility GPS data were used. Household clusters were spatially linked with facilities using buffers. Descriptive analyses were performed and generalized estimating equations (GEE) were used to determine the effects of having different types of facilities at varying distances from household clusters on receipt of maternal and newborn PNC in rural Malawi.<h4>Results</h4>In rural Malawi, around 96% of women had facilities providing PNC within 10?km of where they live. Among women who have clinic-level facilities within 5?km of where they live, around 25% had clinic-level facilities that provide PNC. For rural women who gave birth in the past 5?years preceding the survey, only about 3% received maternal PNC within 24?h and about 16% received maternal PNC within the first week. As for newborn PNC, 3% of newborns had PNC within 24?h and about 26% had newborn PNC within the first week. PNC mostly took place at facilities (94% for women and 95% for newborns). For women who delivered at home, having a health center providing PNC within 5?km was positively associated with maternal and newborn PNC. For women who delivered at facilities, having a health center providing PNC within 5?km was positively associated with maternal PNC and having a health center providing PNC between 5?km and 10?km was positively associated with both maternal and newborn PNC. Regardless of the place of delivery and distance band, having a clinic-level facility providing PNC did not have significant positive effects on maternal and newborn PNC.<h4>Conclusions</h4>Providers should be trained to perform quality PNC at all facilities. It would also be important to address concerns related to health workers. Lastly, it would be key to increase community awareness about the importance of seeking timely PNC and about the utility of lower-level facilities for receiving preventative PNC.
Project description:Every year an estimated three million neonates die globally and two hundred thousand of these deaths occur in Pakistan. Majority of these neonates die in rural areas of underdeveloped countries from preventable causes (infections, complications related to low birth weight and prematurity). Similarly about three hundred thousand mother died in 2010 and Pakistan is among ten countries where sixty percent burden of these deaths is concentrated. Maternal and neonatal mortality remain to be unacceptably high in Pakistan especially in rural areas where more than half of births occur.This community based cluster randomized controlled trial will evaluate the impact of an Emergency Obstetric and Newborn Care (EmONC) package in the intervention arm compared to standard of care in control arm. Perinatal and neonatal mortality are primary outcome measure for this trial. The trial will be implemented in 20 clusters (Union councils) of District Rahimyar Khan, Pakistan. The EmONC package consists of provision of maternal and neonatal health pack (clean delivery kit, emollient, chlorhexidine) for safe motherhood and newborn wellbeing and training of community level and facility based health care providers with emphasis on referral of complicated cases to nearest public health facilities and community mobilization.Even though there is substantial evidence in support of effectiveness of various health interventions for improving maternal, neonatal and child health. Reduction in perinatal and neonatal mortality remains a big challenge in resource constrained and diverse countries like Pakistan and achieving MDG 4 and 5 appears to be a distant reality. A comprehensive package of community based low cost interventions along the continuum of care tailored according to the socio cultural environment coupled with existing health force capacity building may result in improving the maternal and neonatal outcomes. The findings of this proposed community based trial will provide sufficient evidence on feasibility, acceptability and effectiveness to the policy makers for replicating and scaling up the interventions within the health system.