Community based management of neonatal sepsis in developing countries

To determine the effect of community based programs that address the management of neonatal sepsis compared to similar programs that do not include antibiotic treatment on neonatal mortality in neonates with confirmed or suspected sepsis in developing countries.

We will conduct subgroup analyses for the following questions:

1. Which class of antibiotic is used?
Aminoglycosides, penicillins, cephalosporins and trimethoprim-sulphamethoxazole (cotrimoxazole) in various combinations.

2. What is the route of administration of the antibiotics?

Injectable vs. oral

3. What is the duration of antibiotics administered?
Seven, ten or fourteen days of antibiotic therapy

4. Who delivers the antibiotics?
Community or village health worker vs. doctor vs. other health professional

5. What are the components of the newborn care program?

We will attempt to classify the intensity of the program into grades such as intensive, moderate, not intensive. We anticipate programs will include some or all of the following: mass community education, education of mothers and families, rural infrastructure development, home-visits to actively detect neonates with sepsis, provision of clean delivery kits to birth attendants, supervision and training of birth attendants or health workers, nutritional supplements to pregnant and lactating mothers, maternal antepartum and intrapartum antibiotics as well as essential newborn care components such as ensuring early and exclusive breast feeding, clean delivery, skin, eye and cord care, newborn resuscitation, management of hypothermia etc. Since the focus of this review is the use of antibiotics in neonates, maternal antepartum or intrapartum antibiotics will not be analyzed in this review as interventions. However, the impact of maternal antibiotics will be evaluated in a separate review as part of antibiotic based management strategies for neonatal sepsis in community settings.

6. Were antibiotics being used or provided in the control arm?
Standardized and systematic as part of an ongoing program vs. individually sought on a non-systematic, non-standardized basis vs. no antibiotics

This is a protocol.