Background
Globally, ~15M infants are born prematurely each year, including 360,000 in the United States. These infants require specialized care in Neonatal Intensive Care Units (NICUs) due to their inability to coordinate sucking, swallowing, and breathing. Gastric tube insertion is a common procedure for gavage feeding, as it allows for the necessary delivery of nutrition. NICU babies also often need respiratory support, such as continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC). Monitoring vital signs like heart rate, respiratory rate, blood pressure, temperature, and peripheral oxygen saturation is also crucial for maintaining their stability and health. However, current approaches to feeding and respiratory support in NICU infants have significant limitations. Traditional single-lumen gastric tubes cannot simultaneously feed and vent gas, potentially causing complications such as abdominal distention and respiratory interference. CPAP is also associated with nasal septal injury and requires intensive nursing care. HFNC lacks the ability to provide pressure feedback from the airway, making it challenging to ensure adequate respiratory support. Also, traditional vital sign monitoring involves adhesive electrodes or transducers attached to the skin, which can cause skin breakdown and increased risk of infection.
Technology overview
The multifunction-in-one orogastric tube is a groundbreaking medical device that addresses these limitations. This innovative tube features a double-lumen design, with a feeding lumen that delivers milk and a venting lumen that releases gas, enabling simultaneous and continuous feeding and venting. The tube also features advanced monitoring capabilities, including sensors for continuous pH monitoring, impedance sensors for fluid detection, pressure sensors to monitor stomach contractions and intrathoracic pressure, and electrode rings for electrocardiogram (ECG) signals. The tube also includes position markers for easy visualization on x-rays and ultrasound, and a venting chamber with a one-way valve to manage transient regurgitation of stomach contents. This comprehensive design reduces the need for multiple invasive procedures, thereby enhancing overall care for preterm infants.
Benefits
This innovative technology represents a significant advancement in the field of neonatal care through the following features:
- Continuous monitoring of airway pressure will facilitate a transfer of infants from resource heavy CPAP to ‘pressure targeted high flow’ respiratory support’
- Simultaneous feeding and venting prevents the need for mechanical ventilation.
- Reduced time on intravenous nutrition, by enhancing tolerance of enteral feeds, leads to significant cost savings during the hospital stay.
- Continuous pH monitoring confirms gastric placement, eliminating the need for regular laborious pH testing and reducing the number of x-rays required
- Visibility on point-of-care ultrasound helps avoid the need for x-ray confirmation of the tube’s position
- Reduced calorie losses from vomiting: by allowing transient regurgitation, the tube reduces calorie losses, aiding infant’s growth
- Early detection of sepsis and necrotizing enterocolitis via gastric pressure monitoring improves survival and reduces healthcare costs.
- Comprehensive monitoring capabilities reduce the need for multiple invasive procedures.
Opportunity
In 2005, the societal cost of preterm birth was estimated at $26B per year. The tube’s benefits highlight its potential to 1) significantly improve the care and comfort of preterm infants, 2) increase likelihood of healthy survival, and 3) offer potential cost savings to healthcare providers and society. The neonatal (preterm) infant care market is expected to grow at a CAGR of 6.90% and reach $4.68B by 2029. This growth is attributed to the increase in the number of neonatal healthcare facilities globally, along with the rise in the number of premature newborns in both developed and developing economies.
