Simple Clinical Criteria to Identify Sepsis or Pneumonia in Neonates in the Community Needing Treatment or Referral

Abhay T. Bang, MD, MPH; Rani A. Bang, MD, MPH; M Hanimi Reddy, PhD; Sanjay B. Baitule, DHMS; Mahesh D. Deshmukh, MSc; Vinod K. Paul, MD, PhD; Tom F. de C. Marshal, PhD

Disclosures

Pediatr Infect Dis J. 2005;24(4):335-341. 

In This Article

Abstract and Introduction

Background: Sepsis, meningitis and pneumonia annually kill 1.1 million neonates in developing countries; most deaths occur at home.
Objectives: To develop simple clinical criteria, enabling health workers in communities to identify neonates with potentially fatal sepsis; and to identify the danger signs alerting mothers to seek care.
Methods: In a field trial in 39 villages in Gadchiroli, India, trained health workers visited all neonates at home 8 times during the first 28 days of life, recording signs and outcome without interventions during 1995-1996 and with home-based management of sick neonates during 1996-1999. An independent neonatologist assigned the cause of death. We use the term sepsis to include sepsis, meningitis and pneumonia. We evaluated 31 signs as predictors of 43 sepsis deaths among 3567 neonates. We also evaluated mothers' observations as the danger signs to seek care.
Results: Simultaneous presence of any 2 of 7 signs (reduced or stopped sucking; weak or no cry; limbs becoming limp; vomiting or abdominal distension; baby cold to touch; severe chest indrawing; umbilical infection) predicted sepsis death with sensitivity 100%, specificity 92%, positive predictive value 27.2% and negative predictive value 100% in the nonintervention period. The criteria identified 10.6% of the neonates in the community as suspected sepsis, at a mean of 5.4 days before death. The criteria remained valid in the postintervention period. Any 1 of the 5 maternally observed danger signs (reduced sucking, drowsy or unconscious, baby cold to touch, fast breathing and chest indrawing) gave 100% sensitivity and identified 23.9% neonates for seeking care.
Conclusion: These criteria identify neonates in the community who are at risk for dying of infection with excellent sensitivity, specificity and negative predictive value but a moderate positive predictive value. They can be used by health workers to select sick neonates for treatment or referral. One potentially fatal case would be treated per 4 presumptive cases treated.

Of the 4 million neonatal deaths each year, nearly 98% occur in developing countries.[1] Neonatal sepsis, which we define as septicemia, meningitis, pneumonia causes an estimated 1.1 million deaths per year.[2] Most neonates never reach the hospital; moreover pediatricians or facilities for bacterial culture are not available at most peripheral health facilities in developing countries. Simple methods to identify neonatal sepsis in the community for antibiotic treatment or referral are needed.

Simple clinical criteria developed earlier for diagnosing pneumonia in children younger than 5 years[3,4] are used in the Global Program on Acute Respiratory Infections.[5] Management of sick neonates was excluded from this strategy and from the Integrated Management of Childhood Illnesses (IMCI) strategy of the World Health Organization (WHO) and UNICEF,[6] because adequate evidence about methods to identify and treat sick neonates in the community was lacking. The clinical algorithms to diagnose the sick child in the IMCI strategy have been recently evaluated in studies in Gambia, Kenya and Bangladesh.[7,8,9] Two of these studies excluded all neonates, one excluded the early neonatal period and none developed the criteria for diagnosis of sepsis.

A WHO-sponsored multicenter study on serious bacterial infections in infants 0-90 days of age[10] found that clinical criteria have a valid predictive relationship but that the clinical instrument developed is too cumbersome for use. Authors of the same study have recently reanalyzed the data and reported that 14 clinical variables showed significant association with severe disease or death in infants <2 months of age. However, the specificity was poor, resulting in many unnecessary referrals. The authors concluded, Further studies are required to validate and refine the prediction of severe disease, especially in the first week of life, but there appear to be limits on the accuracy of prediction that is achievable.[11]

Earlier studies[3,4,7,8,9,10,11] were all clinic- or hospital-based, with consequent overrepresentation of sick children. Evaluation of screening criteria on such selected populations leads to overestimation of sensitivity and specificity, because of the verification bias,[10] making the extrapolation of clinic- or hospital-based criteria to community setting questionable. However, evaluation studies involving invasive procedures such as blood culture or lumber puncture cannot be conducted on community-based populations that include asymptomatic neonates for ethical reasons and because of parental refusal.[10]

We reported a field trial of home-based neonatal care and management of sepsis in rural Gadchiroli, India, in which the neonatal mortality rate (NMR) in the intervention area was reduced by 62%.[12] That field trial generated data based on prospective observation of neonates in rural homes.

The objectives of this study were to develop simple clinical criteria, enabling health workers in communities to identify neonates likely to die of sepsis, and to identify the danger signs alerting mothers to seek care. We did this by evaluating the various signs as predictors of death due to sepsis in neonates in community.

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