ABSTRACT
Background: The bubble continuous positive airway pressure (bCPAP) technique is widely applied in neonatal respiratory support. Commercial bCPAP brands are expensive in Nigeria and this has driven Nigerian paediatricians to use potentially risky improvised devices (IbCPAP). Aim: This study aimed to design, produce and trial an appropriate low-cost bCPAP machine which is functionally effective and safe. Methods: Questionnaires were distributed to assess the need for a new bCPAP design for use in Nigeria, leading to the development of a new system (politeCPAP) which was functionally and clinically validated in three Nigerian hospitals. Six months of clinical data on the new device of sufficient comparative quality were generated from one of the hospitals and compared with control data on the IbCPAP. The hospitals (n = 3) submitted data on 71 patients on IbCPAP or politeCPAP; 14 were disqualified on the basis of the elimination criteria. The infants were classified into two birthweight categories: <1000 g (extremely low birthweight, ELBW, n = 15) and 1000 g (n = 42). Results: Six ELBW neonates on politeCPAP survived; there were no ELBW survivors in the IbCPAP group (n = 9). The IbCPAP device delivered an average 90% O2-gas ratio (FiO2) whereas the politeCPAP required only 47%. Many heavier neonates in the IbCPAP group survived (23 of 26); however, supplementary warming was required for all of them whereas none of the politeCPAP infants required warming. The politeCPAP costs around US$2000 whereas standard commercial CPAP brands in Nigeria range from US$5000 to US$18,000. High oxygen requirement and iatrogenic hypothermia were serious adverse features of IbCPAP. Conclusions: The study has narrowed the gap between relatively low-cost, risky devices (e.g. IbCPAP) and high-cost commercial machines. The politeCPAP is a feasible alternative to the IbCPAP in cost-constrained settings. Abbreviations: bCPAP: bubble continuous positive airway pressure; CPAP: continuous positive airway pressure; ELBW: extremely low birthweight; FiO2: ratio of oxygen content in gas flow (%); IbCPAP: improvised bubble continuous positive airway pressure device; LBW: low birthweight; NNU: neonatal unit; PEEP: positive end expiratory pressure; politeCPAP: the newly developed commercial bCPAP machine; RDS: respiratory distress syndrome; SpO2, oxygen saturation level (%).
