A Pragmatic Cluster Randomized Trial of the Impact of Newborn Infection Management at Health Posts on Neonatal Mortality in Rural Ethiopia

Presenter: Tedbabe Degefie Hailegebriel, Save the Children

Background: To improve newborn survival by increasing coverage of treatment of neonatal infections, the Community Based Interventions for Newborns in Ethiopia (COMBINE) study evaluated a strategy of providing treatment at the most peripheral level of the system, the health post, for families unable to access referral care. The objective was to evaluate a strategy to make treatment for neonatal infections available at health posts for families unable to access referral care, in order to increase coverage of life-saving treatment and improve newborn survival.

Methods: We performed a two-arm, community-based, cluster-randomized trial. In both study arms, the existing health system was strengthened at health posts and referral sites (health centers) and instituted home visits during pregnancy and postnatal period. In addition, in the intervention arm, antibiotic treatment for newborn infections was made available at health posts when referral was not possible. The primary study outcome was post day-1 neonatal mortality. Analysis was by intention to treat.

Results: Among 576 newborns presenting with one or more signs of infection at intervention health posts, 521 (90%) were recorded as treated at the health post and 41 (7%) as referred. Of the cases treated at health posts, 487(97%) received 7 doses of gentamicin. Post day-1 neonatal mortality declined more in the intervention arm than the comparison arm between baseline and endline (13.8 to 11.2 per 1000 in the comparison arm; 18.2 to 9.4 per 1000 in the intervention arm). After taking baseline mortality rates and region into account, there was evidence for a reduction in mortality due to the intervention (risk ratio 0•70; 95% CI 0•48 to 1•01; P=0•06).

Conclusion: When referral is not possible, antibiotic treatment of newborns at health posts is feasible and can contribute to reducing neonatal mortality.