Device for Treatment of Congenital Diaphragmatic Hernia

DESCRIPTION provided by applicant Congenital diaphragmatic hernia CDH affects in newborns CDH is a disorder in which part of the diaphragm fails to form allowing abdominal organs to migrate into the chest resulting in lung hypoplasia underdevelopment in affected infants Although great strides have been made in the management of this disease significant morbidity and mortality persist Pooled results from over centers worldwide indicate overall survival to be with standard postnatal therapy Specific morbidities in survivors include neurodevelopmental nutritional sensorineural hearing and pulmonary function deficiencies The public health impact of this disease is also significant as evidenced by a recent study that has identified CDH has the third most costly birth defect The severe consequences of this congenital anomaly have led others to pursue methods of correcting CDH or its main consequence lung hypoplasia prior to birth allowing for more normal postnatal function The most promising in utero therapy developed thus far consists of complete occlusion of the fetal trachea cTO which has been shown to encourage lung growth However this procedure impairs the phasic mechanical forces that are known to critically regulate proper lung development Despite progression from animal experiments to ongoing human trials cTO has yet to be demonstrated as superior to standard postnatal therapy and is currently reserved for use in only the most severely affected fetuses To overcome this we have proposed the use of a miniature valve system to provide dynamic tracheal occlusion dTO For the Phase I project we propose the following Specific Aims Optimize dTO valve flow dependence and outflow pressure settings for ideal lung development for severe lung hypoplasia and Optimize dTO valve flow dependence and outflow pressure settings for ideal lung development for moderate lung hypoplasia PUBLIC HEALTH RELEVANCE Congenital diaphragmatic hernia CDH afflicts approximately in newborns As common as cystic fibrosis and spina bifida CDH incurs significant long term morbidity mortality and socioeconomic costs due to poor fetal lung development The ultimate goal of the proposed STTR project is to apply novel technologies to develop a miniature device for treatment of CDH