VoluSense Pediatrics in the neonatal unit

The respiratory system is poorly developed at birth especially in preterm infants. Despite advances in the management and care of these babies, respiratory disease remains a primary cause of morbidity and mortality. One hurdle towards improved care has been a lack of accurate monitoring systems adapted for use on babies. 

VoluSense Pediatrics has been developed to assist neonatologists and pediatricians in evaluating infant lung function. The information provided is useful when evaluating the need for and the effects of clinical interventions.

VoluSense Pediatrics measures volume changes in a wrap-around vest. The systems provides visual and quantitative information on tidal flow, tidal volume, minute volume, respiration frequency and thoraco-abdominal asynchrony. Such information will be familiar for clinicians who use invasive ventilation systems, but has been unavailable for babies breathing on their own. 

Designed with the neonate in mind

The system is easy to use and is well-tolerated by even very small premature babies. The nurse-operated measurement process takes about 5-10 minutes for a resting baby. The patient can be monitored for a longer period if desirable. Gently dressing a baby in a vest will take just a minute or two. The vest can be used to monitor the respiratory status of both intubated and self-ventilating babies. No mask is needed to complete the measurement. VoluSense allows real-time monitoring using the mobile bedside device. The information in the logged plots and data can also be analysed in more detail later on an external PC.

VoluSense measurement vests are produced from comfortable, stretchy materials to avoid any undue distress to the baby. The vest can be opened and closed as needed for rapid access to the baby. They are manufactured at sizes suitable for premature and term neonatal patients. 

Clinical application

VoluSense can be used in many clinical situations:

- Drug treatment: e.g. diuretics, inhaled bronchodilators, inhaled corticosteroids, systemic corticosteroids

- Management: 

- CPAP – optimal settings

- CPAP – weaning from CPAP

- Ventilated babies

- Weaning from mechanical ventilation

- High and low flow oxygen therapy

- Babies with chronic respiratory diseases including BPD/CLD, recurrent apnoeas

- Well babies:

- Use in conjunction with other monitors to evaluate wellbeing of infant including obstructive breathing or apnoeas

- Normal values:

- Establish normal breathing parameters. Most data is currently based on using a pneumotachograph, which provides unnaturally high values due to introduction of increased dead space and increased work of breathing.

Background

There is no patient- and user friendly non-invasive device currently available that can provide lung function information for neonates. The lack of such objective information may result in  delays in the detection of any deterioration of lung function and may result in over- or under-treatment with mechanical ventilation, CPAP or other interventions. Since it is well-established that prolonged breathing assistance in the newborn results in long term morbidity in the form of bronchopulmonary dysplasia (BPD), also known as Chronic Lung Disease of Prematurity (CLD), any method that accurately assesses respiratory status in newborn babies would be useful in helping clinicians to better manage their patients.

About 1 in 10 newborns are admitted to intensive care, at a cost of US$3000 per day plus any intervention costs. A large majority of these babies receive some form of breathing support; either via invasive mechanical ventilation for the most premature or sickest babies or via non-invasive respiration support such as CPAP or oxygen administration through the nasal cannula. Pulmonary function diagnostics and monitoring solutions can, in principle, provide key information on clinical status, progress and treatment effect. However, other than the monitors linked to advanced invasive ventilators used for the sickest babies, clinicians in the neonatal care ward lack suitable methods to assess pulmonary function. This important monitoring challenge still has not been addressed despite an annual global spending of $1.2 billion on all neonatal and perinatal monitoring, including heart rate and blood oxygen monitoring, x-rays and blood tests (LSI, 2008). 

There is an acute need for better measuring and monitoring of respiratory status in newborns. Neonatal Respiratory Distress Syndrome (RDS) affects a large proportion of babies born before the 30th week of gestation and over 40% born between 30 and 32 weeks of gestation. Bronchopulmonary Dysplasia is diagnosed in over 60% born before the 26th week, declining to 3% at 30-32 weeks. Breathing interruptions (apnoea) occur in 85% of infants before 30 weeks. Respiratory Syncytial Virus, a major cause of respiratory morbidity in newborn babies, infects a large majority of children before age 2 including some neonatal intensive care patients. Those born preterm with BPD are particularly at risk. Together, these conditions represent a considerable risk of morbidity and death, and are associated with poor growth and development.


Other applications

VoluSense meets an urgent clinical need in the neonatal unit. VoluSense also holds promise for measuring important lung function parameters as an alternative to mask-based systems in other patient groups, including unconscious adults and older children:

- Conditions of older children and adults where VoluSense may be useful:

- Acute conditions e.g. bronchiolitis

- Acute respiratory conditions in PICU including pneumonia, ARDS, etc.

- Neuromuscular diseases

- Sleep disorders and long term ventilation, including improvements after intervention such as with CPAP 

- Weaning from long term ventilation

- Responses to both new and established drugs in children and adults

- Cystic fibrosis including responses to treatment

- Long term outlook in established conditions

- Long term respiratory conditions e.g., COPD
 

We welcome discussions with parties interested in co-development or in co-marketing partnerships.