Using the Neovent Device for Breathing Support in Newborns with Respiratory Distress in Low-Resource Hospitals in Nigeria and Nepal

What this Trial Is About

Breathing problems are a major cause of newborn death and illness worldwide, especially in countries with limited healthcare resources like Nigeria and Nepal. This research focuses on newborns with mild to moderate respiratory distress and aims to test the feasibility and safety of using a low-cost breathing support device called the Neovent, which provides nasal intermittent positive pressure ventilation NIPPV. The study seeks to show that healthcare providers in low-resource nurseries can use the Neovent effectively and safely, comparing it to the current standard, bubble continuous positive airway pressure CPAP. The goal is to see if the Neovent causes no more safety issues such as nasal irritation, nosebleeds, stomach problems, or air around the lungs than the existing CPAP treatment. Newborns who qualify will be placed on the Neovent device for 6 hours, during which healthcare providers will set up, operate, and monitor the device. The study will track how well the staff can manage the device and identify any safety concerns. The Neovent is a non-electric, low-cost device designed to deliver NIPPV, which helps breathing by providing alternating air pressure through small nasal tubes. This study will take place in hospitals in Nigeria and Nepal and involves 70 newborn infants. During the 6-hour monitoring period, researchers will record vital signs like oxygen saturation, respiratory rate, heart rate, and the Downes score to assess breathing distress. They will also check hourly for complications such as nasal injury, nosebleeds, abdominal swelling, and pneumothorax. Safety assessments will be verified by study physicians. The main outcome is to confirm proper setup and use of the Neovent by healthcare providers and to ensure the safety profile is comparable to existing treatments. Participation will last for the duration of the 6-hour observation period.

Feasibility of Using the Neovent in Low-Resource Settings