The first clinical study of a low-cost neonatal breathing system created by Rice University bioengineering students demonstrated that the device increased the survival rate of newborns with severe respiratory illness from 44 percent to 71 percent.
The results, which were published online this week in the open-access journal PLOS ONE, came from a 10-month study of 87 patients at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi. Based on data from the study, it is estimated that treatment with low-cost "bubble CPAP" could save the lives of 178,000 low-birth-weight babies in Africa each year.
The researchers found that premature infants with complications like sepsis, very low birth weight and respiratory distress syndrome (RDS) benefited most from the new technology. Survival rates more than doubled for babies with RDS and more than tripled for babies in the other two categories after treatment with bubble CPAP. The technology is a low-cost version of the continuous positive airway pressure (CPAP) systems that are a standard feature of most neonatal units in the developed world.
"Premature birth is now the second leading cause of death among children worldwide, and most premature babies are born in low-resource settings where many of the basic technologies and approaches that lead to improved outcomes are unavailable," said Dr. Elizabeth Molyneux, a pediatrician at QECH, who co-authored the report with colleagues from Rice, QECH, Baylor College of Medicine, and the University of Malawi. "The results from the bubble CPAP clinical study are dramatic, and thanks to the partnership of QECH, Rice and the Malawi Ministry of Health, we are already implementing bubble CPAP nationwide."
CPAP helps babies breathe more easily by keeping their lungs inflated, but with a price around $6,000, conventional neonatal CPAP machines are too expensive for hospitals in the developing world. In 2010, a team of Rice bioengineering students invented a low-cost bubble CPAP device. The technology, which costs about 15 times less than conventional CPAP machines, was created as part the Rice 360-: Institute for Global Health Technologies' award-winning, hands-on engineering education program, Beyond Traditional Borders (BTB).
QECH, the main referral hospital in southern Malawi, admits about 3,000 babies per year to its neonatal ward. The 2012 clinical study involved newborns suffering from respiratory distress. Patients were treated with bubble CPAP whenever a machine and trained staff were available. The study included data from 62 infants who were treated with bubble CPAP and a control group of 25 infants who received nasal oxygen from an oxygen concentrator, the current standard of care in Malawi.
The survival rate for babies treated with bubble CPAP was 71 percent, compared with 44 percent for the control group. The survival rates for infants with the following complications were also much higher if the babies were treated with bubble CPAP: respiratory distress syndrome, 64 percent with bubble CPAP compared with 23 percent without; very low birth weight, 65 percent with bubble CPAP compared with 15 percent without; and sepsis, 61 percent with bubble CPAP and zero without.
"The improvement that we saw for premature babies with respiratory distress syndrome mirrored the improvement that was seen in the United States when CPAP was first introduced here," said Rice's Rebecca Richards-Kortum, the Stanley C. Moore Professor and chair of the Department of Bioengineering and director of both BTB and Rice 360-.
Respiratory distress claims the lives of about 1 million African newborns each year. Based on the dramatic results from the study, QECH, Rice 360- and the Malawi Ministry of Health have partnered to provide bubble CPAP at all 27 of the country's government hospitals. To date, 22 of the machines have been installed at nine hospitals, and 354 clinicians have been trained to use them.
