BAEBIES, INC. — Department of Health and Human Services SBIR Phase I: NIDA

Description

ABSTRACT A Novel Workflow to Screen for Illicit Drug Exposure in NewbornsRFA DANeonatal abstinence syndromeNASrefers to a spectrum of withdrawal symptoms in newborns who were exposed to illicit or addictive substances in uteroBabies with NAS have higher rates of fetal anomaliescongenital malformationsgrowth restrictionischemic placental complicationsand perinatal issuespreterm deliverypoor feedingsleep difficultiesdiarrheaseizureswhich together raise the risk for adverse long term outcomesRates of NAS have skyrocketed during the last decade and estimates suggest thatof mothers use at least one addictive drug during their pregnancyTo address this public health crisismultiple groups including the American College of Obstetrics and Gynecology and the American Academy of Pediatrics recommend universal screening of substance use in pregnancy using standardized behavioral scoring toolsUnfortunatelysuch tools are often biased due to subjective scoring or self reporting errorsand fail to identify babies who did not receive proper prenatal careEarly identification of NAS is essential for referral of affected babies for interventionsincluding pharmacological treatments and behavioral social support for the familySelect hospitals in Ohio and Texas are already engaged in universal toxicology based newborn screeningNBSfor NASand several state public health programs are evaluating feasibility to incorporate NAS screening into their standard NBS panelsWhile toxicology NBS for NAS is expanding in the U Sseveral factors currently restrict the growth of such programsThese includelimited sensitivity and short history of exposure with existing tests for urine and blood sampleschallenging methodologies for meconium sample processinglimited testing options for meconium samplesand long turnaround times for the few existing meconium testsThe potential consequences of delayed or otherwise insufficient NAS screening include increased errors and or delays in pharmacologic treatmentshigh costs associated with unnecessary hospitalizationand increased risk for misdiagnosisTo combat these challengeswe propose a novel workflow that will enable rapid toxicology screening of urine or meconium samples in the hospitalOur system will pair a simple sample preparation protocol with a high sensitivity panel of homogeneous enzyme immunoassays recognizing five common classes of drugsfentanylmorphineamphetamine methamphetaminecocaineand benzodiazepinesThe tests will be automated on an innovative digital microfluidic analyzer with a total time to resultincluding sample processing timeof underhoursThe product of this research meets the goals of RFA DAto developinnovative methods to identify and treat newborns exposed to opioidsand will furthermore support the goals of the American Academy of Pediatrics to expand high sensitivity NAS screeningThe potential benefits from implementation of our protocol include reduced length of hospitalization for unaffected newbornsaccelerated time to confirmatory resultsfaster resolution of acute withdrawal symptomsand improved referral to family maternal support services PROJECT NARRATIVE Neonatal abstinence syndromeNASrefers to the numerous and diverse withdrawal symptoms in newborns who were exposed to illicit or addictive substances in uteroEarly identification of NAS through neonatal screeningobservational and toxicological testing in tandemis essential to diagnosing affected babies for appropriate interventionsincluding pharmacological treatments and behavioral social support for the familyOur proposed novel testing platform will enable rapid toxicology screening of urine or meconium samples in the hospital to recognize five classes of drugs commonly impacting NAS newbornsfentanylmorphineamphetaminescocaineand benzodiazepinesImprovements to the diagnosis process through our workflow include reduced length of hospitalization for unaffected newbornsutilization of sample types with increased sensitivityaccelerated time to confirmatory resultsfaster resolution of acute withdrawal symptomsand improved referral to family maternal support services