Family-centred interventions for Indigenous early childhood well-being by primary healthcare services.

BACKGROUND: Primary healthcare, particularly Indigenous-led services, are well placed to deliver services that reflect the needs of Indigenous children and their families. Important characteristics identified by families for primary health care include services that support families, accommodate sociocultural needs, recognise extended family child-rearing practices, and Indigenous ways of knowing and doing business. Indigenous family-centred care interventions have been developed and implemented within primary healthcare services to plan, implement, and support the care of children, immediate and extended family and the home environment. The delivery of family-centred interventions can be through environmental, communication, educational, counselling, and family support approaches. OBJECTIVES: To evaluate the benefits and harms of family-centred interventions delivered by primary healthcare services in Canada, Australia, New Zealand, and the USA on a range of physical, psychosocial, and behavioural outcomes of Indigenous children (aged from conception to less than five years), parents, and families. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 22 September 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster RCTs, quasi-RCTs, controlled before-after studies, and interrupted time series of family-centred care interventions that included Indigenous children aged less than five years from Canada, Australia, New Zealand, and the USA. Interventions were included if they met the assessment criteria for family-centred interventions and were delivered in primary health care. Comparison interventions could include usual maternal and child health care or one form of family-centred intervention versus another. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. overall health and well-being, 2. psychological health and emotional behaviour of children, 3. physical health and developmental health outcomes of children, 4. family health-enhancing lifestyle or behaviour outcomes, 5. psychological health of parent/carer. 6. adverse events or harms. Our secondary outcomes were 7. parenting knowledge and awareness, 8. family evaluation of care, 9. service access and utilisation, 10. family-centredness of consultation processes, and 11. economic costs and outcomes associated with the interventions. We used GRADE to assess the certainty of the evidence for our primary outcomes. MAIN RESULTS: We included nine RCTs and two cluster-RCTs that investigated the effect of family-centred care interventions delivered by primary healthcare services for Indigenous early child well-being. There were 1270 mother-child dyads and 1924 children aged less than five years recruited. Seven studies were from the USA, two from New Zealand, one from Canada, and one delivered in both Australia and New Zealand. The focus of interventions varied and included three studies focused on early childhood caries; three on childhood obesity; two on child behavioural problems; and one each on negative parenting patterns, child acute respiratory illness, and sudden unexpected death in infancy. Family-centred education was the most common type of intervention delivered. Three studies compared family-centred care to usual care and seven studies provided some 'minimal' intervention to families such as education in the form of pamphlets or newsletters. One study provided a minimal intervention during the child's first 24 months and then the family-centred care intervention for one year. No studies had low or unclear risk of bias across all domains. All studies had a high risk of bias for the blinding of participants and personnel domain. Family-centred care may improve overall health and well-being of Indigenous children and their families, but the evidence was very uncertain. The pooled effect estimate from 11 studies suggests that family-centred care improved the overall health and well-being of Indigenous children and their families compared no family-centred care (standardised mean difference (SMD) 0.14, 95% confidence interval (CI) 0.03 to 0.24; 2386 participants). We are very uncertain whether family-centred care compared to no family-centred care improves the psychological health and emotional behaviour of children as measured by the Infant Toddler Social Emotional Assessment (ITSEA) (Competence domain) (mean difference (MD) 0.04, 95% CI -0.03 to 0.11; 2 studies, 384 participants). We assessed the evidence as being very uncertain about the effect of family-centred care on physical health and developmental health outcomes of children. Pooled data from eight trials on physical health and developmental outcomes found there was little to no difference between the intervention and the control groups (SMD 0.13, 95% CI -0.00 to 0.26; 1961 participants). The evidence is also very unclear whether family-centred care improved family-enhancing lifestyle and behaviours outcomes. Nine studies measured family health-enhancing lifestyle and behaviours and pooled analysis found there was little to no difference between groups (SMD 0.16, 95% CI -0.06 to 0.39; 1969 participants; very low-certainty evidence). There was very low-certainty evidence of little to no difference for the psychological health of parents and carers when they participated in family-centred care compared to any control group (SMD 0.10, 95% CI -0.03 to 0.22; 5 studies, 975 parents/carers). Two studies stated that there were no adverse events as a result of the intervention. No additional data were provided. No studies reported from the health service providers perspective or on outcomes for family's evaluation of care or family-centredness of consultation processes. AUTHORS' CONCLUSIONS: There is some evidence to suggest that family-centred care delivered by primary healthcare services improves the overall health and well-being of Indigenous children, parents, and families. However, due to lack of data, there was not enough evidence to determine whether specific outcomes such as child health and development improved as a result of family-centred interventions. Seven of the 11 studies delivered family-centred education interventions. Seven studies were from the USA and centred on two particular trials, the 'Healthy Children, Strong Families' and 'Family Spirit' trials. As the evidence is very low certainty for all outcomes, further high-quality trials are needed to provide robust evidence for the use of family-centred care interventions for Indigenous children aged less than five years.

Modelling factors for Aboriginal and Torres Strait Islander child neurodevelopment outcomes: A latent class analysis.

BACKGROUND: The Australian Early Development Census (AEDC) provides a measure of early child development upon school entry. Understanding which combination of factors influences Aboriginal child neurodevelopment is important to inform policy and practice. OBJECTIVE: The primary objective was to use latent class analysis (LCA) to model AEDC profiles and identify the highest need profiles. The secondary objective was to determine the associations of these high need profiles on the likelihood of a child becoming developmentally vulnerable. METHODS: We designed a prospective population-based birth cohort study (n = 2715) using linked data sets with information on Aboriginal cohort children, and their mothers and siblings in Western Australia. Specific developmental indicators in the 2009 and 2012 AEDC were used to assess developmental vulnerability. LCA methods were used to determine need profiles and their association with developmental vulnerability. RESULTS: 49.3% of Aboriginal children were vulnerable on at least one developmental domain, and 37.5% were vulnerable on two or more domains. LCA found six unique profiles. High needs family, High needs young mother, and Preterm infant comprised 42% of the cohort and were considered to have high need configurations. These groups were at least 1.7 times as likely to have children who had at least one or two developmental vulnerabilities compared with the Healthy family group. CONCLUSION: Many Aboriginal children in Western Australia enter school with at least one developmental vulnerability. This study highlights a range of unique profiles that can be used to empower Aboriginal families for change and develop targeted programmes for improving the early development of young Aboriginal children.

Conditional cash transfers to improve use of health facilities by mothers and newborns in conflict affected countries, a prospective population based intervention study from Afghanistan.

BACKGROUND: The effects of conditional cash transfer (CCT) programs on maternal and child health (MCH) service use in conflicted affected countries such as Afghanistan are not known. METHODS: We conducted a non-randomised population based intervention study in six Afghanistan districts from December 2016 to December 2017. Six control districts were purposively matched. Women were eligible to be included in the baseline and endline evaluation surveys if they had given birth to one or more children in the last 12 months. The intervention was a CCT program including information, education, communication (IEC) program about CCT to community members and financial incentives to community health workers (CHWs) and families if mothers delivered their child at a health facility. Control districts received standard care. The primary objective was to assess the effect of CCT on use of health facilities for delivery. Secondary objectives were to assess the effect of CCT on antenatal care (ANC), postnatal care (PNC) and CHW motivation to perform home visits. Outcomes were analysed at 12 months using multivariable difference-in-difference linear regression models adjusted for clustering and socio demographic variables. RESULTS: Overall, facility delivery increased in intervention villages by 14.3% and control villages by 8.4% (adjusted mean difference [AMD] 3.3%; 95% confidence interval [- 0.14 to 0.21], p value 0.685). There was no effect in the poorest quintile (AMD 0.8% [- 0.30 to 0.32], p value 0.953). ANC (AMD 45.0% [0.18 to 0.72] p value 0.004) and PNC (AMD 31.8% [- 0.05 to 0.68] p value 0.080) increased in the intervention compared to the control group. CHW home visiting changed little in intervention villages (- 3.0%) but decreased by - 23.9% in control villages (AMD 12.2% [- 0.27 to 0.51], p value 0.508). CCT exposure was 27.3% (342/1254) overall and 10.2% (17/166) in the poorest quintile. CONCLUSIONS: Our study demonstrated that a CCT program provided to women aged 16-49 years can be implemented in a highly conservative conflict affected population. CCT should be scaled up for the poorest women in Afghanistan.

Anemia in disadvantaged children aged under five years; quality of care in primary practice.

BACKGROUND: Anemia rates are over 60% in disadvantaged children yet there is little information about the quality of anemia care for disadvantaged children. METHODS: Our primary objective was to assess the burden and quality of anemia care for disadvantaged children and to determine how this varied by age and geographic location. We implemented a cross-sectional study using clinical audit data from 2287 Indigenous children aged 6-59 months attending 109 primary health care centers between 2012 and 2014. Data were analysed using multivariable regression models. RESULTS: Children aged 6-11 months (164, 41.9%) were less likely to receive anemia care than children aged 12-59 months (963, 56.5%) (adjusted odds ratio [aOR] 0.48, CI 0.35, 0.65). Proportion of children receiving anemia care ranged from 10.2% (92) (advice about 'food security') to 72.8% (728) (nutrition advice). 70.2% of children had a hemoglobin measurement in the last 12 months. Non-remote area families (115, 38.2) were less likely to receive anemia care compared to remote families (1012, 56.4%) (aOR 0.34, CI 0.15, 0.74). 57% (111) aged 6-11 months were diagnosed with anemia compared to 42.8% (163) aged 12-23 months and 22.4% (201) aged 24-59 months. 49% (48.5%, 219) of children with anemia received follow up. CONCLUSIONS: The burden of anemia and quality of care for disadvantaged Indigenous children was concerning across all remote and urban locations assessed in this study. Improved services are needed for children aged 6-11 months, who are particularly at risk.

Can community health worker home visiting improve care-seeking and maternal and newborn care practices in fragile states such as Afghanistan? A population-based intervention study.

BACKGROUND: The effects of community health worker (CHW) home visiting during the antenatal and postnatal periods in fragile- and conflicted-affected countries such as Afghanistan are not known. METHODS: We conducted a non-randomised population-based intervention study from March 2015 to February 2016. Two intervention and two control districts were selected. All female CHWs in the intervention districts were trained to provide eight home visits and behaviour change communication messages from pregnancy to 28 days postpartum. The primary outcome was the proportion of women who reported delivering in a health facility. Secondary outcomes were the proportion of women who reported attending a health facility for at least one antenatal and one postnatal visit. Outcomes were analysed at 12 months using multivariable difference-in-difference linear regression models adjusted for clustering. RESULTS: Overall, 289 female CHWs in the intervention districts performed home visits and 1407 eligible women (less than 12 months postpartum) at baseline and 1320 endline women provided outcome data (94% response rate). Facility delivery increased in intervention villages by 8.2% and decreased in the control villages by 6.3% (adjusted mean difference (AMD) 11.0%, 95% confidence interval (CI) 4.0-18.0%, p = 0.002). Attendance for at least one antenatal care visit (AMD 10.5%, 95% CI 4.2-16.9%, p = 0.001) and postnatal care visit (AMD 7.2%, 95% CI 0.2-14.2%, p = 0.040) increased in the intervention compared to the control districts. CONCLUSIONS: CHW home visiting during the antenatal and postnatal periods can improve health service use in fragile- and conflict-affected countries. Commitment to scale-up from Ministries and donors is now needed. TRIAL REGISTRATION: This trial was retrospectively registered at the Australian and New Zealand Clinical Trial Registry ( ACTRN12618000609257 ).

Barriers associated with care-seeking for institutional delivery among rural women in three provinces in Afghanistan.

BACKGROUND: In the past fifteen years, Afghanistan has made substantial progress in extending primary health care. However, coverage of essential health interventions proven to improve maternal and neonatal health outcomes, particularly skilled birth attendance, remains unacceptably low. This is especially true for those in the poorest quintile of the population. This cross-sectional quantitative and qualitative study assessed barriers associated with care-seeking for institutional delivery among rural Afghan women in three provinces. METHODS: The study was conducted from November to December 2016 in 12 districts across three provinces - Badghis, Bamyan, and Kandahar - which are predominately rural. Districts were used as the primary sampling unit with district-level sample sizes reflecting the ratio of that district's population to provincial population. Villages within these districts, the secondary sampling units, were randomly selected. A household survey was used to collect data on: demographics, socio-economic status, childbearing history, health transport and service costs, maternal health seeking behavior and barriers to service uptake. Data on barriers to facility delivery were compared across provinces using chi square tests. RESULTS: Of the 2479 women of child bearing age interviewed, one-third were from each province (33% n = 813 Badghis, 34% n = 840 Bamyan, 33% n = 824 Kandahar). Among those respondents who had delivered none of their children in a health center, money to pay for services appeared to be most important barrier to accessing institutional delivery (56%, n = 558). No transportation available was the second most widely cited reason (37%, n = 368), followed by family restrictions (n = 30%, n = 302). Respondents in Badghis reported the highest levels of barriers compared to the other two provinces. Respondents in Badghis were more likely to report familial or cultural constraints as the most important barrier to institutional delivery (43%) compared to Bamyan (2%) and Kandahar (12%) (p < 0.001). CONCLUSIONS: Despite the socio-demographic and geographic diversity of the three provinces under study, the top barriers to institutional delivery reported in all three areas are consistent with available evidence, namely, that distance, transport cost and transport availability are the main factors limiting institutional delivery. Proven and promising approaches to overcome these barriers to institutional delivery in Afghanistan should be explored and studied.

Quality of social and emotional wellbeing services for families of young Indigenous children attending primary care centers; a cross sectional analysis.

BACKGROUND: The quality of social and emotional wellbeing services for Indigenous families of young children is not known, in many settings especially services provided by primary care centers. METHODS: Our primary objective was to assess delivery of social and emotional wellbeing services to the families of young (3-11 months) and older (12-59 months) Indigenous children attending primary care centers. Our secondary objective was to assess if delivery differed by geographic location. Two thousand four hundred sixty-six client files from 109 primary care centers across Australia from 2012 to 2014 were analysed using logistic regression and generalised estimating equations. RESULTS: The proportion of families receiving social and emotional wellbeing services ranged from 10.6% (102) (food security) to 74.7% (1216) (assessment of parent child interaction). Seventy one percent (71%, 126) of families received follow up care. Families of children aged 3-11 months (39.5%, 225) were more likely to receive social and emotional wellbeing services (advice about domestic environment, social support, housing condition, child stimulation) than families of children aged 12-59 months (30.0%, 487) (adjusted odds ratio [aOR] 1.68 95% CI 1.33 to 2.13). Remote area families (32.6%, 622) received similar services to rural (29.4%, 68) and urban families (44.0%, 22) (aOR 0.64 95% CI 0.29, 1.44). CONCLUSIONS: The families of young Indigenous children appear to receive priority for social and emotional wellbeing care in Australian primary care centers, however many Indigenous families are not receiving services. Improvement in resourcing and support of social and emotional wellbeing services in primary care centers is needed.

Infant Group B Streptococcal Disease Incidence and Serotypes Worldwide: Systematic Review and Meta-analyses.

BACKGROUND: Group B Streptococcus (GBS) remains a leading cause of neonatal sepsis in high-income contexts, despite declines due to intrapartum antibiotic prophylaxis (IAP). Recent evidence suggests higher incidence in Africa, where IAP is rare. We investigated the global incidence of infant invasive GBS disease and the associated serotypes, updating previous estimates. METHODS: We conducted systematic literature reviews (PubMed/Medline, Embase, Latin American and Caribbean Health Sciences Literature [LILACS], World Health Organization Library Information System [WHOLIS], and Scopus) and sought unpublished data regarding invasive GBS disease in infants aged 0-89 days. We conducted random-effects meta-analyses of incidence, case fatality risk (CFR), and serotype prevalence. RESULTS: We identified 135 studies with data on incidence (n = 90), CFR (n = 64), or serotype (n = 45). The pooled incidence of invasive GBS disease in infants was 0.49 per 1000 live births (95% confidence interval [CI], .43-.56), and was highest in Africa (1.12) and lowest in Asia (0.30). Early-onset disease incidence was 0.41 (95% CI, .36-.47); late-onset disease incidence was 0.26 (95% CI, .21-.30). CFR was 8.4% (95% CI, 6.6%-10.2%). Serotype III (61.5%) dominated, with 97% of cases caused by serotypes Ia, Ib, II, III, and V. CONCLUSIONS: The incidence of infant GBS disease remains high in some regions, particularly Africa. We likely underestimated incidence in some contexts, due to limitations in case ascertainment and specimen collection and processing. Burden in Asia requires further investigation.

Determinants of morbidity associated with infant male circumcision: community-level population-based study in rural Ghana.

OBJECTIVE: Male circumcision services have expanded throughout Africa as part of a long-term HIV prevention strategy. We assessed the effect of type of service provider (formal and informal) and hygiene practices on circumcision-related morbidities in rural Ghana. METHODS: Population-based, cross-sectional study conducted between May and December 2012 involving 2850 circumcised infant males aged under 12 weeks. Multivariable logistic regression models were adjusted for maternal age, maternal education, income, birthweight and site of circumcision. RESULTS: A total of 2850 (90.7%) infant males were circumcised. Overall, the risk of experiencing a morbidity (defined as complications occurring during or after the circumcision procedure as reported by the primary caregiver) was 8.1% (230). Risk was not significantly increased if the circumcision was performed by informal providers (121, 7.2%) vs. formal health service providers (109, 9.8%) [adjusted odds ratio (aOR) 1.11, 95% CI 0.80-1.47, P = 0.456]. Poor hygiene practices were associated with significantly increased risk of morbidity: no handwashing [148 (11.7%)] (aOR 1.78, 95% CI 1.27-2.52, P = 0.001); not cleaning circumcision instruments [174 (10.6%)] (aOR 1.80, 95% CI 1.27-2.54, P = 0.001); and uncleaned penile area [190 (10.0%)] (aOR 1.84, 95% CI 1.25-2.70, P = 0.002). CONCLUSION: The risk of morbidity after infant male circumcision in rural Ghana is high, chiefly due to poor hygiene practices. Governmental and non-governmental organisations need to improve training of circumcision providers in hygiene practices in sub-Saharan Africa.

Effect of early neonatal vitamin A supplementation on mortality during infancy in Ghana (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Results of randomised controlled trials of newborn (age 1-3 days) vitamin A supplementation have been inconclusive. The WHO is coordinating three large randomised trials in Ghana, India, and Tanzania (Neovita trials). We present the findings of the Neovita trial in Ghana. METHODS: This study was a population-based, individually randomised, double-blind, placebo-controlled trial in the Brong Ahafo region of Ghana. The trial participants were infants aged at least 2 h, identified at home or facilities on the day of birth or in the next 2 days, able to feed orally, and likely to stay in the study area for at least 6 months. They were randomly assigned (ratio 1:1) to receive either one oral dose of vitamin A (50,000 IU) or placebo immediately after recruitment. The research team and parents of the infants were masked to treatment assignment. Follow-up home visits were undertaken every 4 weeks, when data were recorded for deaths, facility use, and care seeking. The primary outcome was post-supplementation mortality to 6 months of age. Analysis was by intention to treat. Potential adverse events were recorded at 1 and 3 days after supplementation. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)CTRN12610000582055. FINDINGS: We assessed 26,414 livebirths for eligibility between Aug 16, 2010, and Nov 7, 2011. We recruited 22,955 newborn infants, with 11,474 randomly assigned to receive vitamin A and 11,481 to receive placebo. Loss to follow-up was low with vital status at 6 months of age reported for 22,698 (98·9%) infants. We recorded 278 post-supplementation deaths to 6 months of age in the vitamin A group (mortality risk 24·5 in 1000 supplemented infants) and 248 deaths in the placebo group (mortality risk 21·8 per 1000 supplemented infants), relative risk (RR) 1·12 (95% CI 0·95-1·33; p=0·183) and risk difference (RD) 2·66 (95% CI -1·25 to 6·57; p=0·18). Adverse events within 3 days of supplementation did not differ by trial group. 122 infants died in the first 3 days after supplementation; 70 (0·6%) in the vitamin A and 52 (0·5%) in the placebo group (risk ratio [RR] 1·35, 95% CI 0·94-1·93, p=0·102). 53 infants were reported to have a bulging fontanelle; 32 (0·3%) in the vitamin A group and 21 (0·2%) in the placebo group (RR 1·53, 0·88-2·62, p=0·130). INTERPRETATION: The results of this trial do not support inclusion of newborn vitamin A supplementation as a child survival strategy in Ghana. FUNDING: Bill & Melinda Gates Foundation grant to the WHO.

Effectiveness of the Koorliny Moort out-of-hospital health care program for Aboriginal and Torres Strait Islander children in Western Australia.

OBJECTIVES: To determine whether the Koorliny Moort program could reduce emergency department presentations, hospital admissions and length of stay, and improve attendance at out-of-hospital appointments for Aboriginal and Torres Strait Islander children in Western Australia. DESIGN: Children were enrolled in the program from 1 August 2012. Each child acted as their own control. Evaluation data were collected from 1 August 2010 to 31 July 2014. Occasions of service and person-time in days were compared for each child before and after referral to the program. SETTING AND PARTICIPANTS: Aboriginal children aged 0-16 years residing in three WA regions (Kimberley, Pilbara, Perth metropolitan) who were referred to the Koorliny Moort program. INTERVENTIONS: Partnerships with primary care providers; nurse-led care coordination; and outreach care by paediatricians, nurses and social workers closer to the home of the child. MAIN OUTCOME MEASURES: Emergency department presentations; hospital admissions; length of hospital stay; non-attended appointments. RESULTS: A total of 942 children were referred to the program. There were significant decreases after referral to the program in the incidence of emergency department presentations (incident rate ratio [IRR], 0.47; 95% CI, 0.43-0.53; P < 0.001), of hospitalisation (IRR, 0.70; 95% CI, 0.62-0.79; P < 0.001), and of non-attended appointments (IRR, 0.83; 95% CI, 0.74-0.94; P < 0.001), as well as in the mean length of hospital stay (IRR, 0.23; 95% CI, 0.21-0.25; P < 0.001). CONCLUSIONS: Health-seeking behaviour and health outcomes for Aboriginal children can be improved by engaging Aboriginal families in their health care, providing effective communication between health service providers, and delivering a coordinated program of Aboriginal service provider-led care.

Barriers in physical access to maternal health services in rural Ethiopia.

BACKGROUND: Identifying women with poor access to health services may inform strategies for improving maternal and child health outcomes. The aim of this study was to explore risk factors associated with access to health facilities (in terms of physical distance) among women of reproductive age (15-49 years) in Dabat district, a rural area of north-western Ethiopia. METHODS: A randomly selected cross sectional survey of 1,456 rural households was conducted. Data were collected during home visits. Data on household assets and socio-demographic data (including age, education level, occupation, religion and ethnicity) were collected on 1,420 women. A geographic information system (GIS) was used to map locations of all households, the district health centre and the smaller health posts. Travel time from households to health facilities was estimated, incorporating information on the topography and terrain of the area. The primary outcomes were: 1) travel time from household to nearest health post 2) travel time from household to health centre. Analysis was conducted using multiple linear regression models and likelihood ratio tests. RESULTS: This study found evidence that educated women lived closer to health centres than uneducated women (adjusted mean difference (adj MD) travel time -41 min (95% CI: -50,-31)) in this community. Woman's age was also associated with distance to the health centre. Women aged 15-20 years were more likely to live in a poor access area compared with women aged 21-30 years (adj MD travel time -11 min (95% CI: -23, 0)), and with women aged 31-49 years (adj MD travel time -32 min (95% CI: -47,-17)). There was no evidence to suggest that travel time to the health centre was associated with household wealth. CONCLUSIONS: Our main aim was to address the almost total lack of research evidence on what socio-demographic characteristics of women of reproductive age influence access to health facilities (in terms of physical distance). We have done so by reporting that our study found an association that women with no education and women who are younger live, on average, further away from a health facility in this rural Ethiopian community. While we have generated this valuable information to those who are responsible for providing maternal and child health services locally, to fully understand access in health care and to promote equitable access to health care, our study could thus be extended to other components of access and explore how our findings fit into the wider context of other factors influencing maternal health outcomes and utilisation of maternal health services such as antenatal care or delivery at health facility.

Global Management of Serious Bacterial Infections in Young Infants Aged 0 to 59 Days: An Overview of Systematic Reviews.

BACKGROUND: To inform World Health Organization guidelines for the management of serious bacterial infection (SBI) (suspected or confirmed sepsis, pneumonia, or meningitis) in infants aged 0-59 days. OBJECTIVE: To conduct an "overview of systematic reviews" to: (1) understand which systematic reviews have examined diagnosis and management of SBI in infants aged 0-59 days in the last 5 years; and (2) assess if the reviews examined PICOs (population, intervention, comparator, outcomes) and regimens currently being recommended in low and middle income countries (LMICs) by the World Health Organization. DATA SOURCES: MEDLINE; Embase; Cochrane Library; Epistemonikos; PROSPERO. STUDY SELECTION: Systematic reviews of randomized controlled trials or observational studies of infants aged 0-59 days examining diagnostic accuracy and antibiotic regimens for SBI from January 1, 2018 to November 3, 2023. DATA EXTRACTION: Dual independent extraction of study characteristics, PICOs, and methodological quality. RESULTS: Nine systematic reviews met our criteria. Two reviews examined diagnostic accuracy for sepsis, and no reviews examined pneumonia or meningitis. Five reviews examined antibiotic effectiveness (sepsis [n = 4]; pneumonia [n = 1]), and no reviews examined meningitis. One review examined antibiotic duration for sepsis and one for meningitis, and no reviews for pneumonia. Only 4 of the 9 systematic reviews met criteria for high-quality. LIMITATIONS: Our review was limited to the last 5 years to inform current guideline updates. CONCLUSIONS: Few studies have examined antibiotic regimens currently being used in LMICs and quality is of concern in many studies. More high-quality data are needed to inform management of SBI in newborns, especially in LMICs.

Efficacy of Antibiotic Regimens for Meningitis in Young Infants Aged 0-59 Days: A Systematic Review.

CONTEXT: Meningitis is associated with high mortality risk in young infants, yet the optimal treatment regimen is unclear. OBJECTIVES: To systematically evaluate the efficacy of antibiotic regimens to treat meningitis in young infants aged 0 to 59 days on critical clinical outcomes. DATA SOURCES: MEDLINE, Embase, CINAHL, WHO Global Index Medicus, and Cochrane Central Registry of Trials. STUDY SELECTION: We included randomized controlled trials (RCTs) of young infants with meningitis (population) comparing the efficacy of antibiotic regimens (interventions) with alternate regimens (control) on clinical outcomes. DATA EXTRACTION: We extracted data on study characteristics and assessed risk of bias in duplicate. Grading of Recommendations Assessment, Development, and Evaluation was used to assess certainty of evidence. RESULTS: Of 1088 studies screened, only 2 RCTs were identified. They included 168 infants from 5 countries and were conducted between 1976 and 2015. Neither study compared current World Health Organization-recommended regimens. One multisite trial from 4 countries compared intrathecal gentamicin plus systemic ampicillin/gentamicin to systemic ampicillin/gentamicin and found no difference in mortality (relative risk, 0.88; 95% confidence interval, 0.41-1.53; 1 trial, n = 98, very low certainty of evidence) or adverse events (no events in either trial arm). Another trial in India compared a 10-day versus 14-day course of antibiotics and found no difference in mortality (relative risk, 0.88; 95% confidence interval, 0.41-1.53; 1 trial, n = 98, very low certainty of evidence) or other outcomes. CONCLUSIONS: Trial data on the efficacy of antibiotic regimens in young infant meningitis are scarce. Rigorous RCTs are needed to inform recommendations for optimal antibiotic regimens for meningitis treatment in this vulnerable population, particularly within the context of changing epidemiology and increasing antimicrobial resistance.

Predictive Accuracy of Infant Clinical Sign Algorithms for Mortality in Young Infants Aged 0 to 59 Days: A Systematic Review.

CONTEXT: Clinical sign algorithms are a key strategy to identify young infants at risk of mortality. OBJECTIVE: Synthesize the evidence on the accuracy of clinical sign algorithms to predict all-cause mortality in young infants 0-59 days. DATA SOURCES: MEDLINE, Embase, CINAHL, Global Index Medicus, and Cochrane CENTRAL Registry of Trials. STUDY SELECTION: Studies evaluating the accuracy of infant clinical sign algorithms to predict mortality. DATA EXTRACTION: We used Cochrane methods for study screening, data extraction, and risk of bias assessment. We determined certainty of evidence using Grading of Recommendations Assessment Development and Evaluation. RESULTS: We included 11 studies examining 26 algorithms. Three studies from non-hospital/community settings examined sign-based checklists (n = 13). Eight hospital-based studies validated regression models (n = 13), which were administered as weighted scores (n = 8), regression formulas (n = 4), and a nomogram (n = 1). One checklist from India had a sensitivity of 98% (95% CI: 88%-100%) and specificity of 94% (93%-95%) for predicting sepsis-related deaths. However, external validation in Bangladesh showed very low sensitivity of 3% (0%-10%) with specificity of 99% (99%-99%) for all-cause mortality (ages 0-9 days). For hospital-based prediction models, area under the curve (AUC) ranged from 0.76-0.93 (n = 13). The Score for Essential Neonatal Symptoms and Signs had an AUC of 0.89 (0.84-0.93) in the derivation cohort for mortality, and external validation showed an AUC of 0.83 (0.83-0.84). LIMITATIONS: Heterogeneity of algorithms and lack of external validation limited the evidence. CONCLUSIONS: Clinical sign algorithms may help identify at-risk young infants, particularly in hospital settings; however, overall certainty of evidence is low with limited external validation.

Efficacy of Antibiotic Regimens for Pneumonia in Young Infants Aged 0-59 Days: A Systematic Review.

CONTEXT: Pneumonia is a leading cause of death in young infants. OBJECTIVES: To evaluate the efficacy of different antibiotic regimens to treat young infant pneumonia on critical clinical outcomes. DATA SOURCES: MEDLINE, Embase, CINAHL, World Health Organization (WHO) Global Index Medicus, Cochrane Central Registry of Trials. STUDY SELECTION: We included randomized controlled trials of young infants aged 0 to 59 days with pneumonia (population) comparing the efficacy of antibiotic regimens (intervention) with alternate regimens or management (control) on clinical outcomes. DATA EXTRACTION: We extracted data and assessed risk of bias in duplicate. We used Grading of Recommendations, Assessment, Development, and Evaluation to assess certainty of evidence. LIMITATIONS: Trials were heterogeneous, which precluded data pooling. RESULTS: Of 2601 publications screened, 10 randomized controlled trials were included. Seven trials were hospital-based (n = 869) and 3 were nonhospital-based (n = 4329). No hospital-based trials evaluated WHO-recommended first-choice regimens. One trial found the WHO-recommended second-choice antibiotic, cefotaxime, to have similar rates of treatment success as non-WHO-recommended regimens of either amoxicillin-clavulanate (RR 0.99, 95% confidence interval 0.82-1.10) or amoxicillin-clavulanate/cefotaxime (RR 1.02, 95% confidence interval 0.86-1.12). Among 3 nonhospital-based trials comparing oral amoxicillin to alternate regimens to treat isolated tachypnea among infants aged 7-59 days, there were no differences in treatment failure between amoxicillin and alternate regimens. Certainty of evidence was low or very low for all primary outcomes. CONCLUSIONS: We found limited evidence to support the superiority of any single antibiotic regimen over alternate regimens to treat young infant pneumonia.

Efficacy of Antibiotic Regimens for Sepsis or Possible Serious Bacterial Infection in Young Infants Aged 0 to 59 Days: A Systematic Review and Meta-analysis.

CONTEXT: Sepsis is a leading cause of young infant mortality. OBJECTIVE: To evaluate the efficacy of different antibiotic regimens to treat young infant sepsis or possible serious bacterial infection (PSBI) on clinical outcomes. DATA SOURCES: MEDLINE, Embase, CINAHL, World Health Organization Global Index Medicus, Cochrane Central Registry of Trials. STUDY SELECTION: We included randomized controlled trials (RCTs) of young infants 0 to 59 days with sepsis or PBSI (population) comparing the efficacy of antibiotic regimens (intervention) with alternate regimens or management (control) on clinical outcomes. DATA EXTRACTION: We extracted data and assessed risk of bias in duplicate. We performed random-effects meta-analysis, and used Grading of Recommendations, Assessment, Development, and Evaluation to assess certainty of evidence. RESULTS: Of 2390 publications, we included 41 RCTs (n = 18 054). Thirty-five trials were hospital-based and 6 were nonhospital-based. Meta-analysis of 4 trials demonstrated similar rates of treatment success with intramuscular/intravenous third generation cephalosporins versus intramuscular/intravenous penicillin or ampicillin + gentamicin (RR 1.03, 95% CI 0.93-1.13]; n = 1083; moderate certainty of evidence). Meta-analysis of 3 trials demonstrated similar rates of treatment failure with oral amoxicillin + intramuscular gentamicin versus intramuscular penicillin + gentamicin for nonhospital treatment of clinical severe illness (RR 0.86, 95% CI 0.72-1.02]; n = 5054; low certainty of evidence). Other studies were heterogeneous. LIMITATIONS: RCTs evaluated heterogeneous regimens, limiting our ability to pool data. CONCLUSIONS: We found limited evidence to support any single antibiotic regimen as superior to alternate regimens to treat young infant sepsis or PSBI.

Diagnostic Accuracy of Clinical Sign Algorithms to Identify Sepsis in Young Infants Aged 0 to 59 Days: A Systematic Review and Meta-analysis.

CONTEXT: Accurate identification of possible sepsis in young infants is needed to effectively manage and reduce sepsis-related morbidity and mortality. OBJECTIVE: Synthesize evidence on the diagnostic accuracy of clinical sign algorithms to identify young infants (aged 0-59 days) with suspected sepsis. DATA SOURCES: MEDLINE, Embase, CINAHL, Global Index Medicus, and Cochrane CENTRAL Registry of Trials. STUDY SELECTION: Studies reporting diagnostic accuracy measures of algorithms including infant clinical signs to identify young infants with suspected sepsis. DATA EXTRACTION: We used Cochrane methods for study screening, data extraction, risk of bias assessment, and determining certainty of evidence using Grading of Recommendations Assessment Development and Evaluation. RESULTS: We included 19 studies (12 Integrated Management of Childhood Illness [IMCI] and 7 non-IMCI studies). The current World Health Organization (WHO) 7-sign IMCI algorithm had a sensitivity of 79% (95% CI 77%-82%) and specificity of 77% (95% CI 76%-78%) for identifying sick infants aged 0-59 days requiring hospitalization/antibiotics (1 study, N = 8889). Any IMCI algorithm had a pooled sensitivity of 84% (95% CI 75%-90%) and specificity of 80% (95% CI 64%-90%) for identifying suspected sepsis (11 studies, N = 15523). When restricting the reference standard to laboratory-supported sepsis, any IMCI algorithm had a pooled sensitivity of 86% (95% CI 82%-90%) and lower specificity of 61% (95% CI 49%-72%) (6 studies, N = 14278). LIMITATIONS: Heterogeneity of algorithms and reference standards limited the evidence. CONCLUSIONS: IMCI algorithms had acceptable sensitivity for identifying young infants with suspected sepsis. Specificity was lower using a reference standard of laboratory-supported sepsis diagnosis.

Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis.

BACKGROUND: Despite widespread use of intrapartum antibiotic prophylaxis, group B streptococcus remains a leading cause of morbidity and mortality in infants in Europe, the Americas, and Australia. However, estimates of disease burden in many countries outside of these regions is not available. We aimed to examine the current global burden of invasive disease and the serotype distribution of group B streptococcus isolates. METHODS: We searched Medline, Embase, and Wholis databases for studies on invasive early-onset (day 0-6) and late-onset (day 7-89) group B streptococcal disease. Eligible studies were those that described incidence, deaths, or serotypes. We also reviewed reference lists and contacted experts to seek unpublished data and data missed by our search. Random effects meta-analysis was used to pool data. FINDINGS: 74 studies met the inclusion criteria; 56 studies reported incidence, 29 case fatality, and 19 serotype distribution. An additional search for studies that reported serotype distribution from Jan 1, 1980, yielded a total of 38 articles. Only five low-income countries were represented in the review and contributed 5% weight to the meta-analysis. 47 (69%) studies reported use of any intrapartum antibiotic prophylaxis. Substantial heterogeneity existed between studies. Mean incidence of group B streptococcus in infants aged 0-89 days was 0·53 per 1000 livebirths (95% CI 0·44-0·62) and the mean case fatality ratio was 9·6% (95% CI 7·5-11·8). Incidence of early-onset group B streptococcus (0·43 per 1000 livebirths [95% CI 0·37-0·49]) and case fatality (12·1%, [6·2-18·3]) were two-times higher than late-onset disease. Serotype III (48·9%) was the most frequently identified serotype in all regions with available data followed by serotypes Ia (22·9%), Ib (7·0%), II (6·2%), and V (9·1%). Studies that reported use of any intrapartum antibiotic prophylaxis were associated with lower incidence of early-onset group B streptococcus (0·23 per 1000 livebirths [95% CI 0·13-0·59]) than studies in which patients did not use prophylaxis (0·75 per 1000 livebirths [0·58-0·89]). INTERPRETATION: More high-quality studies are needed to accurately estimate the global burden of group B streptococcus, especially in low-income countries. A conjugate vaccine incorporating five serotypes (Ia, Ib, II, III, V) could prevent most global group B streptococcal disease. FUNDING: Child Epidemiology Reference Group (CHERG), WHO.

Impact of Haemophilus influenzae Type b conjugate vaccine in Mongolia: prospective population-based surveillance, 2002-2010.

OBJECTIVES: Bacterial meningitis is associated with high mortality and long-term complications. This study assessed the impact of Haemophilus influenzae type b (Hib) conjugate vaccine on childhood bacterial meningitis in Ulaanbaatar, Mongolia. STUDY DESIGN: Prospective, active, population-based surveillance for suspected meningitis in children aged 2-59 months was conducted (February 2002-January 2011) in 6 hospitals. Clinical data, blood, and cerebrospinal fluid were collected. The impact of Hib conjugate vaccine was assessed by comparing Hib and all cause meningitis data in the 3 years preceding pentavalent conjugate vaccine implementation (2002-2004) with 3 years postimplementation (2008-2010). RESULTS: Five hundred eleven cases of suspected meningitis were identified from 2002-2011. Pentavalent conjugate vaccine coverage in December 2005 in Ulaanbaatar city was 97%. The proportion of suspected cases confirmed as Hib meningitis decreased from 25% (50/201) in the prevaccination era to 2% (4/193) in the postvaccination era (P < .0001). The annual incidence of Hib decreased from 28 cases per 100,000 children in 2002-2005 to 2 per 100,000 in 2008-2010 (P < .0001). CONCLUSIONS: This article demonstrates the marked impact of Hib conjugate vaccine introduction on meningitis in Mongolia. It is important to sustain this surveillance system to monitor the long-term impact of Hib conjugate vaccine, as well as other interventions such as pneumococcal and meningococcal vaccines.