Low-cost bubble continuous positive airway pressure (CPAP) in Indian tertiary NICU- A mixed -method feasibility study.

The study will be conducted at the NICU of Mysore Medical College and Research Institute in India. Before commencing the study, approval will be obtained from the MMCRI Institutional Ethics Committee. The research will focus on newborns experiencing respiratory distress, and the intervention involves using a low-cost bubble CPAP device. The inclusion criteria encompass all inborn and out-born newborns, including term and preterm infants, requiring respiratory support with bubble CPAP. Various indications for bubble CPAP are outlined, such as respiratory distress, preterm infants with RDS, and apnea of prematurity, among others. Newborns with severe life-limiting congenital anomalies will be excluded from the study. The research will take place in the tertiary NICU of MMCRI, which consists of separate inborn and out-born neonatal units. Standard unit guidelines will be followed, including infection prevention measures, continuous monitoring of vital signs, intravenous fluids, early initiation of enteral feeds, and appropriate antibiotic use. Caffeine will be administered to preterm infants on respiratory support, and those who fail CPAP will be intubated and ventilated. Training on assembling and using the device will be provided to the staff, and a survey will be conducted to assess the device’s ease of use and staff perception. Data will be collected using a pro-forma and a questionnaire-based survey, and both quantitative and qualitative analyses will be conducted. The study will use a convenient sample size, and an internal safety monitoring committee will regularly assess the data. The primary outcome will be mortality, and secondary outcomes include the duration of CPAP use, intubation/mechanical ventilation, surfactant therapy, nasal injury, air leak syndromes, hospital duration, culture-positive sepsis, clinical sepsis, chronic lung disease of prematurity, ROP/NEC/IVH/PDA, and parental consent will be obtained for all babies enrolled in the study. The estimated duration of the study though initially planned for 6 months, later extended to a further 6 months.