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BACKGROUND: To validate a clinical algorithm for community health workers (CHWs) during routine household surveillance for neonatal illness in rural Bangladesh. METHODS: Surveillance was conducted in the intervention arm of a trial of newborn interventions. CHWs assessed 7587 neonates on postnatal days 0, 2, 5 and 8 and identified neonates with very severe disease (VSD) using an 11-sign algorithm. A nested prospective study was conducted to validate the algorithm (n=395). Physicians evaluated neonates to determine whether newborns with VSD needed referral. The authors calculated algorithm sensitivity and specificity in identifying (1) neonates needing referral and (2) mortality during the first 10 days of life. RESULTS: The 11-sign algorithm had sensitivity of 50.0% (95% CI 24.7% to 75.3%) and specificity of 98.4% (96.6% to 99.4%) for identifying neonates needing referral-level care. A simplified 6-sign algorithm had sensitivity of 81.3% (54.4% to 96.0%) and specificity of 96.0% (93.6% to 97.8%) for identifying referral need and sensitivity of 58.0% (45.5% to 69.8%) and specificity of 93.2% (92.5% to 93.7%) for screening mortality. Compared to our 6-sign algorithm, the Young Infant Study 7-sign (YIS7) algorithm with minor modifications had similar sensitivity and specificity. CONCLUSION: Community-based surveillance for neonatal illness by CHWs using a simple 6-sign clinical algorithm is a promising strategy to effectively identify neonates at risk of mortality and needing referral to hospital. The YIS7 algorithm was also validated with high sensitivity and specificity at community level, and is recommended for routine household surveillance for newborn illness. ClinicalTrials.gov no. NCT00198627.

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A large proportion of four million neonatal deaths occur each year during the first 24 hours of life. Research is particularly needed to determine the efficacy of interventions during the first 24 hours. Large cadres of community-based workers are required in newborn-care research both to deliver these interventions in a standardized manner in the home and to measure the outcomes of the study. In a large-scale community-based efficacy trial of chlorhexidine for cleansing the cord in north-eastern rural Bangladesh, a two-tiered system of community-based workers was established to deliver a package of essential maternal and newborn-care interventions and one of three umbilical cord-care regimens. At any given time, the trial employed approximately 133 community health workers--each responsible for 4-5 village health workers and a population of approximately 4,000. Over the entire trial period, 29,760 neonates were enrolled, and 87% of them received the intervention (their assigned cord-care regimen) within 24 hours of birth. Approaches to recruitment, training, and supervision in the study are described. Key lessons included the importance of supportive processes for community-based workers, including a strong training and field supervisory system, community acceptance of the study, consideration of the setting, study objectives, and human resources available.

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BACKGROUND: To devise treatment strategies for neonatal infections, the population-level incidence and antibiotic susceptibility of pathogens must be defined. METHODS: Surveillance for suspected neonatal sepsis was conducted in Mirzapur, Bangladesh, from February 2004 through November 2006. Community health workers assessed neonates on postnatal days 0, 2, 5, and 8 and referred sick neonates to a hospital, where blood was collected for culture from neonates with suspected sepsis. We estimated the incidence and pattern of community-acquired neonatal bacteremia and determined the antibiotic susceptibility profile of pathogens. RESULTS: The incidence rate of community-acquired neonatal bacteremia was 3.0 per 1000 person-neonatal periods. Among the 30 pathogens identified, the most common was Staphylococcus aureus (n = 10); half of all isolates were gram positive. Nine were resistant to ampicillin and gentamicin or to ceftiaxone, and 13 were resistant to cotrimoxazole. CONCLUSION: S. aureus was the most common pathogen to cause community-acquired neonatal bacteremia. Nearly 40% of infections were identified on days 0-3, emphasizing the need to address maternal and environmental sources of infection. The combination of parenteral procaine benzyl penicillin and an aminoglycoside is recommended for the first-line treatment of serious community-acquired neonatal infections in rural Bangladesh, which has a moderate level of neonatal mortality. Additional population-based data are needed to further guide national and global strategies.

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OBJECTIVE: To estimate the validity (sensitivity, specificity, and positive and negative predictive values) of a clinical algorithm as used by community health workers (CHWs) to detect and classify neonatal illness during routine household visits in rural Bangladesh. METHODS: CHWs evaluated breastfeeding and symptoms and signs of illness in 395 neonates selected randomly from neonatal illness surveillance during household visits on postnatal days 0, 2, 5 and 8. Neonates classified with very severe disease (VSD) were referred to a community-based hospital. Within 12 hours of CHW assessments, physicians independently evaluated all neonates seen in a given day by one CHW, randomly chosen from among 36 project CHWs. Physicians recorded symptoms and signs of illness, classified the illness, and determined whether the newborn needed referral-level care at the hospital. Physicians' identification and classification were used as the gold standard in determining the validity of CHWs' identification of symptoms and signs of illness and its classification. FINDINGS: CHWs' classification of VSD showed a sensitivity of 73%, a specificity of 98%, a positive predictive value of 57% and a negative predictive value of 99%. A maternal report of any feeding problem as ascertained by physician questioning was significantly associated (P < 0.001) with 'not sucking at all' and 'not attached at all' or 'not well attached' as determined clinically by CHWs during feeding assessment. CONCLUSION: CHWs identified with high validity the neonates with severe illness needing referral-level care. Home-based illness recognition and management, including referral of neonates with severe illness by CHWs, is a promising strategy for improving neonatal health and survival in low-resource developing country settings.

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