ApneBoot: A Novel Device for Apnea Management in Premature Infants

a built-in pulse oximeter) and resolves episodes of central apeas in newborns by instantaneous tactile stimulation to the foot sole. Devices currently available for managing neonatal apnea, are expensive; imported from high income countries; and only sound an alarm if no breathing is detected but do correct the apnea, making ApneBoot a novel device in the market. The pilot study for ApneBoot reports its accuracy as 94% for apnea detection and 70% for apnea resolution. Ongoing and future studies will look at the efficiency of ApneBoot in reducing the harmful consequences of prolonged hypoxia and also observe if it helps in reducing the workload of hospital personnel.

Apnea of Prematurity (AOP), defined as cessation of breathing lasting for more than 15 seconds and accompanied by hypoxia and/or brady cardia, is a serious risk factor for premature newborns. India has 3.5 million premature babies who are at risk of apneas every year. Prolonged apnea associated with hypoxia and bradycardia may contribute to hypoxic-ischemic injury of the immature brain. Research till date shows that higher frequency and severity of AOP are associated with a higher incidence of adverse outcomes or death, especially in low income settings. AOP is resolved by physical stimulation, often in the form of manual flicking of the baby's sole which triggers a nerve response to stimulate respiratory activity. Our innovation, ApneBoot, is designed to give an assured and instantaneous stimulation in response to an apnea by automating the standard of care flicking process. It alerts for bradycardia, hypoxia (using a built-in pulse oximeter) and resolves episodes of central apeas in newborns by instantaneous tactile stimulation to the foot sole. Devices currently available for managing neonatal apnea, are expensive; imported from high income countries; and only sound an alarm if no breathing is detected but do correct the apnea, making ApneBoot a novel device in the market. The pilot study for ApneBoot reports its accuracy as 94% for apnea detection and 70% for apnea resolution. Ongoing and future studies will look at the efficiency of ApneBoot in reducing the harmful consequences of prolonged hypoxia and also observe if it helps in reducing the workload of hospital personnel.

During informal visits conducted by BEMPU in several government
hospitals across India, we observed that the lack of skilled staff and low nurse to patient ratio leads to sub-optimal management of apnea in newborns. These findings suggested a need for a device that not only detects and alerts but also resolves AOP in newborns in a timely manner. This auto-stimulation device may help in preventing apnea or hypoxia related injury or death in premature babies.

ApneBoot: Device Description
ApneBoot is a wearable device that alerts for bradycardia and hypoxia which are key symptoms of neonatal apnea in premature newborns. Further ApneBoot also resolves these alerted apnea episodes and prolonged hypoxia, which is done via an instantaneous tactile stimulation to the foot sole. The ApneBoot device is designed with a built-in pulse oximeter (with an alarm) and auto-stimulation mechanism that fits on the newborns foot. The device can be worn immediately upon birth and is designed to fit very small babies in the convenient form of a baby boot ( Figure 1). The ApneBoot has an inbuilt algorithm which monitors for drops in oxygen saturation and/or heart rate. In the event of an episode, ApneBoot will;

1)
Provide a vibro-tactile stimulus on the newborn's foot sole, which contains significant nerve endings. This stimulates the nervous system and restarts breathing.

2)
It emits an audiovisual alarm to get the nurse's attention in case the apnea is secondary and requires interventions more than stimulation like assisted ventilation for resolution. The key Features For The Device Include (Figure 2)

1)
The device is reconfigurable to suit all newborns and gives rapid responses: To enhance the product usability and acceptability, the device has settings that are reconfigurable according to the doctor's recommendation. The device can be customized and used either only for monitoring and/ or stimulation. The stimulation threshold intensity can also be adjusted based on the newborn's weight& age, medical conditions and the hospital preferences. It has been reported that the alarm sounds are distressing for the babies in the NICUs [8], necessitating alarm volume level feature in the present device.

2)
It has a high accuracy built-in pulse oximeter that displays apnea duration, oxygen saturation and heart rate: ApneBoot

4)
ApneBoot is safe, portable, robust, reusable and affordable making it an appropriate innovation for low-resource settings: The ApneBoot is evaluated for essential performance and ApneBoot software is written using state machine architecture to implement complex decision-making algorithms for Apnea detection and to respond rapidly to resolve Apnea before any injury can happen. The device is a light weight (~1kg) and easy to carry and designed keeping in mind the ease of use during transportation.

5)
The device has a unique feature of tracking and displaying history of past bradycardia and hypoxia events that may help to identify recurring episodes and underlying causes like infections.

6)
The     safely stimulate a newborn to resolve these apnea episodes.

Clinical Evidence for ApneBoot
The next step will be to look into the potential use of ApneBoot in transport and humanitarian settings due to its reusability and portability. Our future study is being designed to observe and report feedback from users (nurses and doctors) of the device. We also aim to quantify the reduction in workload of SNCU nurses for apnea management before and after ApneBoot use.

Conclusion
The need for a device that helps in managing Apnea of Prematurity (AOP) was realized to reduce the burden of morbidity and mortality in the infant population. ApneBoot is a novel device in the market that not only detects and alerts for apnea but also resolves the episodes by tactile auto-stimulation. A recent clinical study reports the accuracy of the device to be 70%, demonstrating its potential in apnea management especially in low resource settings.