WASHINGTON, D.C. - Simple antibiotic regimens for newborns with severe infections - such as pneumonia and sepsis - in lower income countries is as effective as the standard course of twice daily injections and hospitalization over the course of a week, according to research conducted in Bangladesh, Nigeria, Kenya, and Democratic Republic of Congo.

The promising new evidence published in The Lancet and The Lancet Global Health on April 2, shows a safe, effective and simpler treatment for severe infections can be provided in lower level facilities when access to hospitalization is not possible. If implemented at scale, a significant portion of the 629,000 annual newborn deaths due to infection could be prevented.

The studies documented that families were able to correctly give the necessary oral antibiotics at home when given proper instruction from health care providers. The studies also demonstrated the need for appropriate follow up and monitoring by trained health workers for this strategy to be safe and effective.

"Increasing coverage of newborn sepsis management has been very challenging because it is fraught with so many barriers - distance to health facilities, fear of multiple injections, and cultural issues," said Katie Taylor, Deputy Assistant Administrator at the U.S. Agency for International Development (USAID). "This new evidence will give newborns a fighting chance to survive and thrive during the most perilous period of life - during delivery and the post-natal period when infection poses a grave threat to their survival."

Serious infections are a major cause of illness and death among newborns and young children across the world. Globally, ten percent of all deaths among children younger than five years of age are the result of severe infections like sepsis - a fast progressing life-threatening illness that requires rapid treatment. These deaths account for one quarter of the nearly three million deaths each year during the first 28 days after birth, the newborn period.

"Most deaths due to infection could be averted through simple preventive measures, such as improving hygiene and ensuring curative care is available to sick newborns," says Joy Riggs-Perla, Director of Save the Children's Saving Newborn Lives program. "When families can identify severe infection and start antibiotic treatment early, they dramatically increase a newborn's chance of survival." 

The current standard of treatment for severe infections requires in-patient care and a 7-day treatment, but in developing countries around the world, many families lack access to a hospital due to significant financial or logistical challenges. This leaves thousands of children at risk of not receiving proper care.

The study in Asia tested two alternative antibiotic regimens, combining injectable and oral administration of the drugs. The studies in Africa tested the same two alternatives plus a third even simpler treatment compared to the standard WHO treatment of 14 injections over 7 days.  The simplest alternative treatment included only two days of injectable antibiotic with oral treatment followed by five days of oral antibiotics only.

"Now is the time to bend the curve on maternal and newborn health and accelerate progress," said Mariam Claeson, Director of Maternal Newborn Child Health at the Bill & Melinda Gates Foundation. "A simplified antibiotic regimen means more women in poor countries can access the critical treatment their newborns need to survive. We now have the opportunity to expand this effective, lifesaving treatment and save more newborns than ever before."

By improving access to effective and available treatment, this new regimen promises to save thousands of newborn lives with low cost, effective and commonly available antibiotics. The antibiotics tested in the study - penicillin, amoxicillin, and gentamicin are listed by the  UN Commission on Life-Saving Commodities for Women and Children as high-impact commodities that, if scaled up, can significantly reduce preventable deaths.

"Treating these babies closer to home with fewer injections will expand access to life saving treatment for these newborns, which is critical where hospital care is not always available," said Abdullah Baqui, MBBS, DrPH, MPH, a professor in the Department of International Health and Director of the International Center for Maternal and Newborn Health at the Bloomberg School. "This would save many young lives."

The research was funded by the Bill & Melinda Gates Foundation, Save the Children, USAID, and WHO, in collaboration with the Johns Hopkins Bloomberg School of Public Health and researchers in Nigeria, Bangladesh, D.R. Congo, and Pakistan.

Media contacts:

USAID: Chris Thomas - chthomas@usaid.gov

Save the Children's Saving Newborn Lives: JoAnn Paradis - jparadis@savechildren.org

Johns Hopkins Univ. Bloomberg School of Public Health: Brandon Howard -brandonhoward@jhu.edu

Bill & Melinda Gates Foundation: Katie Harris - katie.harris@gatesfoundation.org