VAYU GLOBAL HEALTH INNOVATIONS, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Respiratory distress syndrome associated with prematuritysepsis and birth asphyxia is a major reason for the mortality of newborns worldwide with over three million newborns dying annually and a much larger number disabledparticularly in resource limited regionsworldwideOxygen therapy delivered via a continuous positive airway pressureCPAPdevice is the most common treatment to address respiratory compromise in these infantsHoweverpure oxygen can place the infant at significant risk of oxygen related damage to the lungseyes and brainA conventional CPAP device is therefore connected to both a compressed air and oxygen tank to control the oxygen content deliveredThe conventional CPAP is often prohibitively expensive in low income regions worldwiderequiring uninterrupted electricitya compressed air tank which isn t easily available and is insufficiently portable for healthcare workers to treat newborns in remote areas worldwideA bubble CPAPbCPAPis a simplermuch less expensive deviceand has been implemented in resource limited areas of several African and Asian countriesHoweverimprovised bCPAP devices deliveroxygenthus placing infants at significant risk of organ damageIn this proposalwe hypothesize that a bubble CPAP device equipped with an adjustable Venturi ambient air oxygen blender will deliver oxygen enriched air efficiently at a controlled percentage ranging fromtoAs our pilot data on fixed Venturi blenders of different designs showsthe fraction of oxygen delivered depends on their geometryThe Specific Aims arefirstto test the hypothesis that a modularadjustable Venturi air oxygen blender can deliver a controlled fraction of oxygenranging fromin a bCPAP device by designing and fabricating the blenderand measuring the fraction of oxygen deliveredsecondto test the hypothesis that the bCPAP device will deliver oxygen efficiently by measuring the minimum flow rate of oxygen required to operate the bCPAP at each fraction of oxygen deliveredSuccessful completion of this project will allow us to develop a bCPAP device that enables the health care provider the flexibility to dial up the oxygen content as needed without having to change blenderswhich would disrupt the treatment and subject the infant to asphyxia in the interim periodthus endangering the infantFurthermorethis ultra low cost device requires no electricity and no air tank since it draws in ambient air into the oxygen streammaking it substantially more portable than a conventional CPAP deviceOur team has already conducted field testing and implemented a bubble CPAP package using a fixed Venturi air oxygen blender in healthcare facilities in Kenya and Indiawhere it is conducting training of local healthcare workers to improve screeningdiagnosis and treatment of respiratory conditions of newbornsOur goal is to decrease respiratory newborn mortality bywithin two years of implementation of our ultra low costbubble CPAP device whose critical component will be our innovativeadjustable ambient air oxygen blender that we hope to designfabricatetest and optimize in this proposal Prematuritysepsis and birth asphyxia result in approximatelymillion deaths among newbornsworldwideand a much larger number are disabled annuallywith respiratory compromise occurring in each of these casesIn this proposal we will designfabricate and validate an adjustablehandheldambient air oxygen blenderwhich is a critical component of an ultra low costportable bubble continuous positive airway pressure device to administer oxygen therapy to newborns undergoing respiratory distressOur novel ambient airoxygen blender willfor the first timeallow the healthcare provider to dial the concentration of oxygen delivered to the newborn without disrupting the therapy to change blenderswhich would otherwise cause asphyxiathus endangering the life of the newborn undergoing treatment