In response, a community cluster randomized controlled trial was done in Nepal, with results published in 2006 (Mullany). The trial demonstrated 24% lower mortality among those randomized to chlorhexidine than those in the control group. Based on this result, Nepal moved forward with operations research and piloting. Last year, a Saving Lives at Birth Grand Challenges grant was made to John Snow, Inc. to assist the government of Nepal in scaling-up chlorhexidine use nation-wide, for use at both home and in institutional deliveries.
Following publication of the Nepal study, replication trials were started in Bangladesh and Pakistan and completed in 2010. Results have been published recently in the Lancet (lead authors Arifeen and Soofi, respectively). All three trials showed significant benefit; across the three, newborn mortality was reduced by about 1/5th.
The main regimen used in the studies was first application on the day of birth, with continued daily application for up to 10 days. However, more detailed analysis of the results from two of the three trials suggest that it is application on the first day that is critical. Indeed, the evidence from these trials suggests that for the mortality reduction effect, application beyond the first day may not be necessary. The regimen adopted for program use in Nepal is day 1 application only.
With this new published evidence, there is now growing interest in this new intervention. For example, it is among the newborn interventions being addressed in the currently ongoing UN Commission on overlooked commodities for maternal-newborn-child health. The WHO is expected, in the near future, to convene an expert group to review this new evidence and consider possible changes in its cord-care guidance. A paper by Susan Hill in the current issue of the Bulletin of the World Health Organization (Bull World Health Organ 2012; 90:236–238) includes chlorhexidine for cord-cleansing in a “wish list of products that could make a difference, if they were available.”
Chlorhexidine is very cheap. The amount of the chemical itself that’s required per newborn costs only pennies. The formulated packaged product used in Nepal is now being procured in bulk for less than $0.15 per tube. In other settings, the exact cost will depend on whether single-day or multi-day regimens are used and on what formulation is chosen.
Although other possibilities have been considered, the two formulations currently in use in trials and early program use are liquid (in a nozzle bottle) and gel (in a tube). In program use, the formulation chosen should be based on setting-specific formative work to determine user preferences.
A number of Asian countries are poised to move forward with chlorhexidine for cord care. In Africa, also, newborn mortality remains very high. Chlorhexidine trials are underway in Zambia and Tanzania and several countries are seriously considering chlorhexidine for piloting or to incorporate directly into their newborn health program work.
Given the evidence now available on the effectiveness of chlorhexidine application to the cord-stump, its low cost, and the relative simplicity of implementation, this intervention is being recognized as an extremely promising new weapon in our battle to reduce newborn mortality—particularly in high mortality burden settings where, typically, hygiene conditions represent an important infection risk for newborns.
This post was originally published by Saving Lives at Birth on March 8, 2012