An Advanced Neonatal Resuscitation Device for Under-resourced Communities
Reducing long-term adverse health outcomes among those that need it most.
Project Background
Around 10 million babies are unable to breathe independently at birth and require resuscitation. In well-resourced healthcare settings, the risk of hypoxia is minimized by trained professionals and high-cost devices. However, nearly 60 million births occur in non-facility settings, leading to hypoxia-related deaths. Low-resource communities typically have trained assistants for child delivery, such as midwives, traditional birth attendants, or community health workers, trained in basic resuscitation via positive-pressure ventilation (PPV) through the detection and modulation of any resulting changes in flow or pressure. Bag-and-mask devices are preferred in these settings due to their simplicity, affordability, availability, and ease of maintenance. More effective and widespread training programs would further reduce infant mortality rates. About 46% of annual deaths of children under 5 years old are caused by hypoxia or acute respiratory distress, with 98% of them occurring in low and middle-income countries. Additionally, the long-term effects of hypoxia on newborn infants can range from neurodevelopmental disorders such as schizophrenia, ADHD, and cerebral palsy, to further cardiovascular issues such as weaker cardiac function and low blood pressure, leading to bradycardia. These often require mechanical ventilation like continuous positive airway pressure (CPAP). CPAP machines are typically expensive, but a study in Malawi showed a significant difference in infant survival with CPAP (30.1%) compared to oxygen treatment (17.9%) in infants with respiratory illness.
Need Statement
There is a need for a simple, cost-effective, and accessible neonatal respiratory resuscitation device for newborn infants, that additionally allows health workers with varying levels of medical training to safely and effectively improve neonatal health outcomes. The device would reduce the risk for asphyxiation, bronchopulmonary dysplasia, and long-term adverse health outcomes for neonates in need of respiratory support in under-resourced communities.
Our Solution
The proposed solution focuses on developing a low-cost bubble CPAP system that prioritizes functionality, sterility, and easy maintenance. The system includes a pressure generator, oxygen blender, pressure gauge, humification component, filters, water chamber, tubing, patient interface, and electronic components.
For the pressure generation in the system, a DC blower will likely be implemented. These are cheap, simple, and tailored to the specifications. Initially a concern due to the overwhelming price tag on many oxygen blenders, an incredibly cost effective method is used in standardized low cost bCPAP devices. These devices use a controlled flowmeter to adjust the amount of oxygen allowed to flow, resulting in a certain concentration of oxygen. The user must consult a chart in order to determine what flow rates to use to achieve certain pressures.
The pressure relief gauge ensures safety in the case of occlusion. A simple mechanical metal sphere implementation would likely be best suited for this application. For patient monitoring, a pressure gauge will likely be worth the cost: it allows the healthcare provider to assess whether or not the patient is receiving an adequate amount of pressure and make needed adjustments.
Low cost bCPAP systems typically lack a humidification and heating chamber. This is very uncomfortable for the neonate and can result in other diseases, making this an important system in the device. The HEPA filter will be integrated in our design for particulate matter protection, and the HPE filter will provide extensive humidification support and antibacterial/antiviral filtration to maximize system sterility. This would not be a bCPAP device without a container of water to set pressure. This is by far the most cost effective part of the system, serving as a foolproof pressure relief valve. To achieve modularity of the system, only a few 3-way valves or other connective valves need to be introduced to allow removal of the oxygen blender and humidifier. The patient interface would be a nasal mask or cannula. The circuitry will be powered by an inexpensive 24V power supply with built in safeguards to prevent damage to the system.
Figure 1: Diagram outlining design of entire bCPAP system.
