Abstract
BackgroundRespiratory failure is a leading cause of neonatal mortality in the developing world. Bubble continuous positive airway pressure (bCPAP) is a safe, effective intervention for infants with respiratory distress and is widely used in developed countries. Because of its high cost, bCPAP is not widely utilized in low-resource settings. We evaluated the performance of a new bCPAP system to treat severe respiratory distress in a low resource setting, comparing it to nasal oxygen therapy, the current standard of care.MethodsWe conducted a non-randomized convenience sample study to test the efficacy of a low-cost bCPAP system treating newborns with severe respiratory distress in the neonatal ward of Queen Elizabeth Central Hospital, in Blantyre, Malawi. Neonates weighing >1,000 g and presenting with severe respiratory distress who fulfilled inclusion criteria received nasal bCPAP if a device was available; if not, they received standard care. Clinical assessments were made during treatment and outcomes compared for the two groups.Findings87 neonates (62 bCPAP, 25 controls) were recruited. Survival rate for neonates receiving bCPAP was 71.0% (44/62) compared with 44.0% (11/25) for controls. 65.5% (19/29) of very low birth weight neonates receiving bCPAP survived to discharge compared to 15.4% (1/13) of controls. 64.6% (31/48) of neonates with respiratory distress syndrome (RDS) receiving bCPAP survived to discharge, compared to 23.5% (4/17) of controls. 61.5% (16/26) of neonates with sepsis receiving bCPAP survived to discharge, while none of the seven neonates with sepsis in the control group survived.InterpretationUse of a low-cost bCPAP system to treat neonatal respiratory distress resulted in 27% absolute improvement in survival. The beneficial effect was greater for neonates with very low birth weight, RDS, or sepsis. Implementing appropriate bCPAP devices could reduce neonatal mortality in developing countries.
Highlights
Severe respiratory distress is a common and serious complication of premature birth, neonatal pneumonia, and neonatal sepsis, which together account for over one-half of all neonatal deaths globally [1]
Multiple logistic regression analysis was performed to adjust for baseline differences in respiratory distress syndrome (RDS), sepsis, and very low birth weight (VLBW); the adjusted survival rate for babies receiving Bubble continuous positive airway pressure (bCPAP) is 85%, while that for standard care is 47% and bCPAP is associated with an adjusted 6.5 fold increase in odds of survival
This study demonstrates the potential impact of introducing a low-cost, appropriate bCPAP system in a low-resource setting where standard therapy is nasal oxygen
Summary
College of Medicine Research and Ethics Committee (P.05/11/ 1079) and the Institutional Review Boards at Baylor College of Medicine (H-29059) and Rice University (11-198F) prior to study initiation. If a bCPAP device or trained clinical staff were not available, the patient received the local standard of care, nasal oxygen (control group). Statistical analysis We planned to recruit a total of 50 patients in the treatment arm, matched 1:1 with controls, giving a total sample size of 100 This would, using a one-sided Fisher’s exact test, achieve at least 85% power to detect at least a 30% mortality reduction with bCPAP treatment compared with oxygen therapy with type I error = 0.05. Multiple logistic regression analysis was used to calculate the survival rates, odds ratio for survival and associated 95% CIs for babies receiving bCPAP compared to standard care, adjusted for differences in baseline values of RDS, sepsis, VLBW
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