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Risk Factors for Neonatal Sepsis and Perinatal Death Among Infants Enrolled in the Prevention of Perinatal Sepsis Trial, Soweto, South Africa

Schrag, Stephanie J. DPhil*; Cutland, Clare L. MD; Zell, Elizabeth R. MStat*; Kuwanda, Locadiah MSc; Buchmann, Eckhart J. MD; Velaphi, Sithembiso C. MD§; Groome, Michelle J. MD; Madhi, Shabir A. MD, PhDthe PoPS Trial Team

The Pediatric Infectious Disease Journal: August 2012 - Volume 31 - Issue 8 - p 821–826
doi: 10.1097/INF.0b013e31825c4b5a
Original Studies

Background: Factors associated with neonatal sepsis, an important cause of child mortality, are poorly described in Africa. We characterized factors associated with early-onset (days 0–2 of life) and late-onset (days 3–28) ­sepsis and perinatal death among infants enrolled in the Prevention of Perinatal Sepsis Trial (NCT00136370 at, Soweto, South Africa.

Methods: Secondary analysis of 8011 enrolled mothers and their neonates. Prenatal and labor records were abstracted and neonatal wards were monitored for hospitalized Prevention of Perinatal Sepsis–enrolled neonates. Endpoint definitions required clinical and laboratory signs. All univariate factors associated with endpoints at P < 0.15 were evaluated using multivariable logistic regression.

Results: About 10.5% (837/8011) of women received intrapartum antibiotic prophylaxis; 3.8% of enrolled versus 15% of hospital births were preterm. Among 8129 infants, 289 had early-onset sepsis, 34 had late-onset sepsis, 49 had culture-confirmed neonatal sepsis and 71 died in the perinatal period. Factors associated with early-onset sepsis included preterm delivery [adjusted relative risk (aRR) = 2.6; 95% confidence interval (CI): 1.4–4.8]; low birth weight (<1500 g: aRR = 6.5, 95% CI: 2.4–17.3); meconium-stained amniotic fluid (MSAF) (aRR = 2.8, 95% CI: 2.2–3.7) and first birth (aRR = 1.8; 95% CI: 1.4–2.3). Preterm, low birth weight, MSAF and first birth were similarly associated with perinatal death and culture-confirmed sepsis. MSAF (aRR = 2.4, 95% CI: 1.1–5.0) was associated with late-onset sepsis.

Conclusions: Preterm and low birth weight were important sepsis risk factors. MSAF and first birth were also associated with sepsis and death, warranting further exploration. Intrapartum antibiotic prophylaxis did not protect against all-cause sepsis or death, underscoring the need for alternate prevention strategies.

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From the *Centers for Disease Control and Prevention, Atlanta, GA; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases & Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Soweto, South Africa; and Department of Obstetrics and Gynaecology and §Department of Paediatrics, Division of Neonatology, Chris Hani Baragwanath Hospital, University of the Witwatersrand, Soweto, South Africa.

Accepted for publication April 11, 2012.

The study was funded by the US Agency for International Development, National Vaccine Program Office, Centers for Disease Control and Prevention’s Antimicrobial Resistance Working Group via CDC Cooperative Agreement numbers U50/CCU021960 and 5U01CI000318, and the Bill and Melinda Gates Foundation Grant number 39415. The sponsors of the study had no role in study design, data gathering, analysis, interpretation, dissemination or in the decision to submit this report for publication. The authors have no other funding or conflicts of interest to disclose.

Address for correspondence: Stephanie J. Schrag, DPhil, MS C25, Centers for Disease Control and Prevention, Atlanta, GA 30333. E-mail:

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© 2012 Lippincott Williams & Wilkins, Inc.