From Pre-Implementation to Institutionalization: Lessons From Sustaining a Perinatal Audit Program in South Africa.

INTRODUCTION: Maternal and perinatal death surveillance and response (MPDSR), or related forms of maternal and perinatal death audits, can strengthen health systems. We explore the history of initiating, scaling up, and institutionalizing a national perinatal audit program in South Africa. METHODS: Data collection involved 56 individual interviews, a systematic document review, administration of a semistructured questionnaire, and 10 nonparticipant observations of meetings related to the perinatal audit program. Fieldwork and data collection in the subdistricts occurred from September 2019 to March 2020. Data analysis included thematic content analysis and application of a tool to measure subdistrict-level implementation. This study expands on case study research applied to 5 Western Cape subdistricts with long histories of implementation. RESULTS: Although established in the early 1990s, the perinatal audit program was not integrated into national policy and guidelines until 2012 but was then excluded from policy in 2021. A network of national and subnational structures that benefited from a continuity of actors evolved and interacted to support uptake and implementation. Intentional efforts to demonstrate impact and enable local adaptation allowed for more ownership and buy-in. Implementation requires continuous efforts. Even in 5 subdistricts with long histories of practice, we found operational gaps, such as incomplete meeting minutes, signaling a need for strengthening. Nevertheless, the tool used to measure implementation may require revisions, particularly in settings with institutionalized practice. CONCLUSION: This article provides lessons on how to initiate, expand, and strengthen perinatal audit. Despite a long history of implementation, the perinatal audit program in South Africa cannot be assumed to be indefinitely sustainable or final in its current form. To monitor uptake and sustainability of MPDSR, including perinatal audit, we need research approaches that allow exploration of context, local adaptation, and underlying issues that support sustainability, such as relationships, leadership, and trust.

Candida bloodstream infection among children hospitalised in three public-sector hospitals in the Metro West region of Cape Town, South Africa.

BACKGROUND: Candida bloodstream infection (BSI) causes appreciable mortality in neonates and children. There are few studies describing the epidemiology of Candida BSI in children living in sub-Saharan Africa. METHODS: A retrospective descriptive study was conducted at three public sector hospitals in Cape Town, South Africa. Demographic and clinical details, antifungal management and patient outcome data were obtained by medical record review. Candida species distribution and antifungal susceptibility testing results were obtained from the National Health Laboratory Service database. RESULTS: Of the 97 Candida BSI episodes identified during a five-year period, 48/97 (49%) were Candida albicans (C. albicans), and 49/97 (51%) were non-C. albicans species. The overall incidence risk was 0.8 Candida BSI episodes per 1000 admissions at Red Cross War Memorial Children's Hospital. Of the 77/97 (79%) Candida BSI episodes with available clinical information, the median age (interquartile range) at the time of BSI was 7 (1-25) months, 36/77 (47%) were associated with moderate or severe underweight-for-age and vasopressor therapy was administered to 22/77 (29%) study participants. Most of the Candida BSI episodes were healthcare-associated infections, 63/77 (82%). Fluconazole resistance was documented among 17%, 0% and 0% of C. parapsilosis, C. tropicalis and C. albicans isolates, respectively. All Candida isolates tested were susceptible to amphotericin B and the echinocandins. The mortality rate within 30 days of Candida BSI diagnosis was 13/75 (17%). On multivariable analysis, factors associated with mortality within 30 days of Candida BSI diagnosis included vasopressor therapy requirement during Candida BSI, adjusted Odds ratio (aOR) 53 (95% confidence interval 2-1029); hepatic dysfunction, aOR 13 (95% CI 1-146); and concomitant bacterial BSI, aOR 10 (95% CI 2-60). CONCLUSION: The study adds to the limited number of studies describing paediatric Candida BSI in sub-Saharan Africa. Non-C. Albicans BSI episodes occurred more frequently than C. albicans episodes, and vasopressor therapy requirement, hepatic dysfunction and concomitant bacterial BSI were associated with an increase in 30-day mortality.

Morbidity and mortality in small for gestational age very preterm infants in a middle-income country.

Objective: To evaluate the impact of small for gestational age (SGA) on outcomes of very preterm infants at Groote Schuur Hospital (GSH), Cape Town, South Africa. Study design: Data were obtained from the Vermont Oxford Network (VON) GSH database from 2012 to 2018. The study is a secondary analysis of prospectively collected observational data. Fenton growth charts were used to define SGA as birth weight < 10th centile for gestational age. Results: Mortality [28.9% vs. 18.5%, adjusted risk ratio (aRR) 2.1, 95% confidence interval (CI) 1.6-2.7], bronchopulmonary dysplasia (BPD; 14% vs. 4.5%, aRR 3.7, 95% CI 2.3-6.1), and late-onset sepsis (LOS; 16.7% vs. 9.6%, aRR 2.3, 95% CI 1.6-3.3) were higher in the SGA than in the non-SGA group. Conclusion: Small for gestational age infants have a higher risk of mortality and morbidity among very preterm infants at GSH. This may be useful for counseling and perinatal management.

Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER).

PURPOSE: The Western Cape Pregnancy Exposure Registry (PER) was established at two public sector healthcare sentinel sites in the Western Cape province, South Africa, to provide ongoing surveillance of drug exposures in pregnancy and associations with pregnancy outcomes. PARTICIPANTS: Established in 2016, all women attending their first antenatal visit at primary care obstetric facilities were enrolled and followed to pregnancy outcome regardless of the site (ie, primary, secondary, tertiary facility). Routine operational obstetric and medical data are digitised from the clinical stationery at the healthcare facilities. Data collection has been integrated into existing services and information platforms and supports routine operations. The PER is situated within the Provincial Health Data Centre, an information exchange that harmonises and consolidates all health-related electronic data in the province. Data are contributed via linkage across a unique identifier. This relationship limits the missing data in the PER, allows validation and avoids misclassification in the population-level data set. FINDINGS TO DATE: Approximately 5000 and 3500 pregnant women enter the data set annually at the urban and rural sites, respectively. As of August 2021, >30 000 pregnancies have been recorded and outcomes have been determined for 93%. Analysis of key obstetric and neonatal health indicators derived from the PER are consistent with the aggregate data in the District Health Information System. FUTURE PLANS: This represents significant infrastructure, able to address clinical and epidemiological concerns in a low/middle-income setting.

Exploring the sustainability of perinatal audit in four district hospitals in the Western Cape, South Africa: a multiple case study approach.

INTRODUCTION: Maternal and perinatal death surveillance and response (MPDSR) is an intervention process that uses a continuous cycle of identification, notification and review of deaths to determine avoidable causes followed by actions to improve health services and prevent future deaths. This study set out to understand how and why a perinatal audit programme, a form of MPDSR, has sustained practice in South Africa from the perspectives of those engaged in implementation. METHODS: A multiple case study design was carried out in four rural subdistricts of the Western Cape with over 10 years of implementing the programme. Data were collected from October 2019 to March 2020 through non-participant observation of seven meetings and key informant interviews with 41 purposively selected health providers and managers. Thematic analysis was conducted inductively and deductively adapting the extended normalisation process theory to examine the capability, contribution, potential and capacity of the users to implement MPDSR. RESULTS: The perinatal audit programme has sustained practice due to integration of activities into routine tasks (capability), clear value-add (contribution), individual and collective commitment (potential), and an enabling environment to implement (capacity). The complex interplay of actors, their relationships and context revealed the underlying individual-level and organisational-level factors that support sustainability, such as trust, credibility, facilitation and hierarchies. Local adaption and the broad social and structural resources were required for sustainability. CONCLUSION: This study applied theory to explore factors that promote sustained practice of perinatal audit from the perspectives of the users. Efforts to promote and sustain MPDSR will benefit from overall good health governance, specific skill development, embedded activities, and valuing social processes related to implementation. More research using health policy and system approaches, including use of implementation theory, will further advance our understanding on how to support sustained MPDSR practice in other settings.

Respiratory Interventions for Preterm Infants in LMICs: A Prospective Study From Cape Town, South Africa.

Background: Preterm birth is a global public health issue and complications of preterm birth result in the death of approximately 1 million infants each year, 99% of which are in low-and-middle income countries (LMIC). Although respiratory interventions such as continuous positive airway pressure (CPAP) and surfactant have been shown to improve the outcomes of preterm infants with respiratory distress, they are not readily available in low-resourced areas. The aim of this study was to report the respiratory support needs and outcomes of preterm infants in a low-resourced setting, and to estimate the impact of a lack of access to these interventions on neonatal mortality. Methods: We conducted a six-month prospective observational study on preterm infants <1,801 g admitted at Groote Schuur Hospital and Mowbray Maternity Hospital neonatal units in Cape Town, South Africa. We extrapolated results from the study to model the potential outcomes of these infants in the absence of these interventions. Results: Five hundred and fifty-two infants (552) <1,801 g were admitted. Three hundred (54.3%) infants received CPAP, and this was the initial respiratory intervention for most cases of respiratory distress syndrome. Surfactant was given to 100 (18.1%) infants and a less invasive method was the most common method of administration. Invasive mechanical ventilation was offered to 105 (19%) infants, of which only 57 (54.2%) survived until discharge from hospital. The overall mortality of the cohort was 14.1% and the hypothetical removal of invasive mechanical ventilation, surfactant and CPAP would result in an additional 157 deaths and increase the overall mortality to 42.5%. A lack of CPAP availability would have the largest impact on mortality and result in the largest number of additional deaths (109). Conclusion: This study highlights the effect that access to key respiratory interventions has on preterm outcomes in LMICs. CPAP has the largest impact on neonatal mortality and improving its coverage should be the primary goal for low-resourced areas to save newborn lives.

Optimal Ventilation and Surfactant Therapy in Very-Low-Birth-Weight Infants in Resource-Restricted Regions.

In resource-restricted regions, respiratory distress syndrome (RDS) data are often underreported, making the determination of effective interventions and their outcome difficult. The combination of oxygen, nasal continuous positive airway pressure (CPAP) and surfactant therapy has the potential to prevent 42% of RDS-related deaths in sub-Saharan Africa, despite the financial implications. This article provides a brief overview on the status of RDS management, mainly nasal CPAP and surfactant therapy in very-low-birth-weight infants, in resource-restricted regions of sub-Saharan Africa. Data from the public health sector, as compared to the private health sector, of the Western Cape province, South Africa, are used to illustrate what RDS management strategies are able to accomplish in a resource-restricted region. Upscaling of all components (antenatal care, antenatal corticosteroids, prevention of hypothermia and RDS management strategies) are required to decrease premature infant mortality rates in resource-restricted areas.

Ending preventable child deaths in South Africa: What role can ward-based outreach teams play?

South Africa (SA) has emerged from the Millennium Development Goal era with a mixture of success and failure. The successful national scale-up of prevention of mother-to-child transmission of HIV services with increasingly efficacious antiretroviral regimens has reduced the mother-to-child transmission rate dramatically; however, over the same period there appears to have been no progress in coverage of high-impact interventions for pneumonia and diarrhoea, which are now leading causes of under-5 mortality. SA embarked on a strategy to re-engineer the primary healthcare system in 2011, which included the creation of ward-based outreach teams consisting of community health workers (CHWs). In this article we argue that the proposed ratio of CHWs to population is too low for public health impact and that the role and scope of CHWs should be extended beyond giving of health information to include assessment and treatment of childhood illnesses (particularly diarrhoea and suspected pneumonia). Evidence and experience amply demonstrate that CHWs in sufficient density can have a rapid and positive impact on neonatal and young child mortality, especially when they are allowed to treat common acute conditions. SA's mediocre performance in child survival could be dramatically improved if there were more CHWs who were allowed to do more.

Counting every stillbirth and neonatal death through mortality audit to improve quality of care for every pregnant woman and her baby.

BACKGROUND: While there is widespread acknowledgment of the need for improved quality and quantity of information on births and deaths, there has been less movement towards systematically capturing and reviewing the causes and avoidable factors linked to deaths, in order to affect change. This is particularly true for stillbirths and neonatal deaths which can fall between different health care providers and departments. Maternal and perinatal mortality audit applies to two of the five objectives in the Every Newborn Action Plan but data on successful approaches to overcome bottlenecks to scaling up audit are lacking. METHODS: We reviewed the current evidence for facility-based perinatal mortality audit with a focus on low- and middle-income countries and assessed the status of mortality audit policy and implementation. Based on challenges identified in the literature, key challenges to completing the audit cycle and affecting change were identified across the WHO health system building blocks, along with solutions, in order to inform the process of scaling up this strategy with attention to quality. RESULTS: Maternal death surveillance and review is moving rapidly with many countries enacting and implementing policies and with accountability beyond the single facility conducting the audits. While 51 priority countries report having a policy on maternal death notification in 2014, only 17 countries have a policy for reporting and reviewing stillbirths and neonatal deaths. The existing evidence demonstrates the potential for audit to improve birth outcomes, only if the audit cycle is completed. The primary challenges within the health system building blocks are in the area of leadership and health information. Examples of successful implementation exist from high income countries and select low- and middle-income countries provide valuable learning, especially on the need for leadership for effective audit systems and on the development and the use of clear guidelines and protocols in order to ensure that the audit cycle is completed. CONCLUSIONS: Health workers have the power to change health care routines in daily practice, but this must be accompanied by concrete inputs at every level of the health system. The system requires data systems including consistent cause of death classification and use of best practice guidelines to monitor performance, as well as leaders to champion the process, especially to ensure a no-blame environment, and to access change agents at other levels to address larger, systemic challenges.

Implementation of the Every Newborn Action Plan: Progress and lessons learned.

Progress in reducing newborn mortality has lagged behind progress in reducing maternal and child deaths. The Every Newborn Action Plan (ENAP) was launched in 2014, with the aim of achieving equitable and high-quality coverage of care for all women and newborns through links with other global and national plans and measurement and accountability frameworks. This article aims to assess country progress and the mechanisms in place to support country implementation of the ENAP. A country tracking tool was developed and piloted in October-December 2014 to collect data on the ENAP-related national milestones and implementation barriers in 18 high-burden countries. Simultaneously, a mapping exercise involving 47 semi-structured interviews with partner organizations was carried out to frame the categories of technical support available in countries to support care at and around the time of birth by health system building blocks. Existing literature and reports were assessed to further supplement analysis of country progress. A total of 15 out of 18 high-burden countries have taken concrete actions to advance newborn health; four have developed specific action plans with an additional six in process and a further three strengthening newborn components within existing plans. Eight high-burden countries have a newborn mortality target, but only three have a stillbirth target. The ENAP implementation in countries is well-supported by UN agencies, particularly UNICEF and WHO, as well as multilateral and bilateral agencies, especially in health workforce training. New financial commitments from development partners and the private sector are substantial but tracking of national funding remains a challenge. For interventions with strong evidence, low levels of coverage persists and health information systems require investment and support to improve quality and quantity of data to guide and track progress. Some of the highest burden countries have established newborn health action plans and are scaling up evidence based interventions. Further progress will only be made with attention to context-specific implementation challenges, especially in areas that have been neglected to date such as quality improvement, sustained investment in training and monitoring health worker skills, support to budgeting and health financing, and strengthening of health information systems.

Early clinical signs in neonates with hypoxic ischemic encephalopathy predict an abnormal amplitude-integrated electroencephalogram at age 6 hours.

BACKGROUND: An early clinical score predicting an abnormal amplitude-integrated electroencephalogram (aEEG) or moderate-severe hypoxic ischemic encephalopathy (HIE) may allow rapid triage of infants for therapeutic hypothermia. We aimed to determine if early clinical examination could predict either an abnormal aEEG at age 6 hours or moderate-severe HIE presenting within 72 hours of birth. METHODS: Sixty infants ≥ 36 weeks gestational age were prospectively enrolled following suspected intrapartum hypoxia and signs of encephalopathy. Infants who were moribund, had congenital conditions that could contribute to the encephalopathy or had severe cardio-respiratory instability were excluded. Predictive values of the Thompson HIE score, modified Sarnat encephalopathy grade (MSEG) and specific individual signs at age 3-5 hours were calculated. RESULTS: All of the 60 infants recruited had at least one abnormal primitive reflex. Visible seizures and hypotonia at 3-5 hours were strongly associated with an abnormal 6-hour aEEG (specificity 88% and 92%, respectively), but both had a low sensitivity (47% and 33%, respectively). Overall, 52% of the infants without hypotonia at 3-5 hours had an abnormal 6-hour aEEG. Twelve of the 29 infants (41%) without decreased level of consciousness at 3-5 hours had an abnormal 6-hour aEEG (sensitivity 67%; specificity 71%). A Thompson score ≥ 7 and moderate-severe MSEG at 3-5 hours, both predicted an abnormal 6-hour aEEG (sensitivity 100 vs. 97% and specificity 67 vs. 71% respectively). Both assessments predicted moderate-severe encephalopathy within 72 hours after birth (sensitivity 90%, vs. 88%, specificity 92% vs. 100%). The 6-hour aEEG predicted moderate-severe encephalopathy within 72 hours (sensitivity 75%, specificity 100%) but with lower sensitivity (p = 0.0156) than the Thompson score (sensitivity 90%, specificity 92%). However, all infants with a normal 3- and 6-hour aEEG with moderate-severe encephalopathy within 72 hours who were not cooled had a normal 24-hour aEEG. CONCLUSIONS: The encephalopathy assessment described by the Thompson score at age 3-5 hours is a sensitive predictor of either an abnormal 6-hour aEEG or moderate-severe encephalopathy presenting within 72 hours after birth. An early Thompson score may be useful to assist with triage and selection of infants for therapeutic hypothermia.

Defining hypoxic ischemic encephalopathy in newborn infants: benchmarking in a South African population.

OBJECTIVES: There are few population-based studies of hypoxic ischemic encephalopathy (HIE) in sub-Saharan Africa, and the published criteria that are used to define and grade HIE are too variable for meaningful comparisons between studies and populations. Our objectives were (1) to investigate how the incidence of HIE in our region varies with different criteria for intrapartum hypoxia and (2) to determine how encephalopathy severity varies with different grading systems. METHOD: We reviewed the records of infants with a diagnosis of HIE born between September 2008 and March 2009 in public facilities in the Southern Cape Peninsula, South Africa.The incidence of HIE was calculated according to four definitions of intrapartum hypoxia and graded according to three methods. RESULTS: Depending on which defining criteria were applied,the incidence of HIE varied from 2.3 to 4.3 per 1000 live births, of mild HIE ranged from 0.4 to 1.3 per 1000 live births, and of moderate-severe HIE ranged from 1.5 to 3.7 per 1000 livebirths. Ninety-seven of the 110 (88%) infants reviewed had at least one intrapartum-related abnormality. Only 62 (56%) infants had a blood gas performed in the fi rst hour of life. CONCLUSION: The incidence and grade of HIE can vary more than 2-fold in the same population, depending on which defining criteria are used. Consensus definitions are needed for benchmarking.

Induced hypothermia for infants with hypoxic- ischemic encephalopathy using a servo-controlled fan: an exploratory pilot study.

OBJECTIVE: Several trials suggest that hypothermia is beneficial in selected infants with hypoxic-ischemic encephalopathy. However, the cooling methods used required repeated interventions and were either expensive or reported significant temperature variation. The objective of this pilot study was to describe the use, efficacy, and physiologic impact of an inexpensive servo-controlled cooling fan blowing room-temperature air. PATIENTS AND METHODS: A servo-controlled fan was manufactured and used to cool 10 infants with hypoxic-ischemic encephalopathy to a rectal temperature of 33 degrees C to 34 degrees C. The infants were sedated with phenobarbital, but clonidine was administered to some infants if shivering or discomfort occurred. A servo-controlled radiant warmer was used simultaneously with the fan to prevent overcooling. The settings used on the fan and radiant warmer differed slightly between some infants as the technique evolved. RESULTS: A rectal temperature of 34 degrees C was achieved in a median time of 58 minutes. Overcooling did not occur, and the mean temperature during cooling was 33.6 degrees C +/- 0.2 degrees C. Inspired oxygen requirements increased in 6 infants, and 5 infants required inotropic support during cooling, but this was progressively reduced after 1 to 2 days. Dehydration did not occur. Five infants shivered when faster fan speeds were used, but 4 of the 5 infants had hypomagnesemia. Shivering was controlled with clonidine in 4 infants, but 1 infant required morphine. CONCLUSIONS: Servo-controlled fan cooling with room-temperature air, combined with servo-controlled radiant warming, was an effective, simple, and safe method of inducing and maintaining rectal temperatures of 33 degrees C to 34 degrees C in sedated infants with hypoxic-ischemic encephalopathy. After induction of hypothermia, a low fan speed facilitated accurate temperature control, and warmer-controlled rewarming at 0.2 degrees C increments every 30 minutes resulted in more appropriate rewarming than when 0.5 degrees C increments every hour were used.