Study protocol of “A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings” SAVE preterm trial, saving preterm infants by adopting vital equipment

Despite a significant global decline in the mortality rate for children under the age of 5, the neonatal mortality rate (NMR) has not significantly improved over the last thirty years. Globally, 250 million newborn babies die each year, and 98% of the neonatal deaths occur in middle- and low-income countries. The leading cause of death is preterm birth; and complications due to the prematurity of the infant include respiratory failure, hypothermia, infections, and dehydration. Treatment for these complications may require respiratory support devices, temperature management using incubators, and Kangaroo Mother Care (KMC). We seek to contribute to the concerted efforts to reduce NMR, which has been declared a target (12 deaths per 1000 live births) within the United Nations Sustainable Development Goal 3. The purpose of the study is to examine the effectiveness of a preterm infant life-saving package toward an improved mortality rate. The package includes a simple and low-cost incubator and a portable flow generator mask-CPAP; which effectively improve sick status and are designed for use in resource limited areas. Inclusion criteria: Preterm infants with respiratory failure who are within two days after birth AND have birth weights between 1200 and 1799 g. The research period was divided into two segments, as follows: Phase 1: pre-intervention period (January 2023 to January 2024). Data collection using a pulse oximeter and thermometer. Incubators and flow generator are not yet implemented. Phase 2: post-intervention period (February 2024 to January 2025). Use of incubators and flow generator. We conduct an interrupted time-series analysis using the monthly proportion of survival discharges in the target population. Ethics approval for this study was obtained from the ethics committees of the governments of Sierra Leone and Laos, where the research was conducted, as well as the ethics committee of Nagasaki University, Japan. Consent to participate in the study was obtained from each participant through signed informed consent forms. Evaluation of the effectiveness of devices available in resource limited settings where neonatal mortality remains high. Examination of the effectiveness of a simple incubator and flow generator as a package based on implementation. The research is conducted in two high neonatal mortality areas; specifically, within Sierra Leone and Laos. A limitation of this study is that the research design is an Interrupted Time Series (ITS). UMIN000053350, UMIN Clinical Trials Registry, Registered 15 Jan, 2024. UMIN Clinical Trials Registry. available from https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060580 .