Breaking the Blood Barrier
A new research collaboration between Northwestern University Feinberg School of Medicine, Hospital Pereira Rossell, Montevideo, Uruguay, and USDTL will investigate the potential for routine newborn screening for prenatal alcohol exposure measuring PEth in dried blood spots.
by Joseph Salerno, MS
United States Drug Testing Laboratories, Inc. was created from the need to more effectively address the issue of neonatal exposure to drugs and alcohol. In our 25 years since that inception we have spearheaded the wave of innovation in neonatal toxicology testing. Continuing a 25 year conviction to protect and enrich newborn lives, researchers at USDTL have embarked on a new research collaboration to investigate routine screening of newborns for prenatal alcohol exposure by measuring the direct alcohol biomarker phosphatidylethanol (PEth) in dried blood spots from both umbilical cord blood and newborn heel sticks. The four year international research grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will provide large-scale data to support routine screening. Research Scientist Dr. Aileen Baldwin, Ph.D., M.P.H., will spearhead USDTL’s efforts in collaboration with prominent neonatal researchers from Northwestern University’s Feinberg School of Medicine (Chicago, IL) and Hospital Pereira Rossell, Montevideo, Uruguay.
Prenatal alcohol exposure is the leading preventable cause of birth defects in the United States. Alcohol use during pregnancy can result in a range of adverse outcomes known as fetal alcohol spectrum disorders (FASD). The most severe cases of FASD, known as fetal alcohol syndrome (FAS) can lead to severe negative impacts on the child, including growth deficiency, central nervous system dysfunction, and changes from normal physiology and behavior.  It is estimated that 8% of U.S. women drink during their pregnancy, leading to an estimated incidence of FASD of 2-5% of all newborns. 
The effects of FASD/FAS can manifest as ongoing developmental issues and can affect a child throughout their lifetime. Early diagnosis of FASD is key to effective interventions and treatments. Children under the age of three may benefit from early neuroplasticity, and early identification of FASD/FAS may reduce long-term adverse effects and help affected children achieve parity with their peers. 
PEth has been shown to be a highly sensitive and specific direct alcohol biomarker for adult alcohol testing.  This research aims to examine the potential for PEth to be a highly sensitive and specific indicator of prenatal alcohol exposure. If successful, the analysis of PEth in dried blood spot cards would be a powerful, universally available testing sample and assay to identify prenatal alcohol exposure.
The four year study, awarded to the Feinberg School of Medicine, is an international collaboration involving USDTL, Dr. Michael Fleming, M.D., M.P.H., (Project Leader and Principle Investigator, Feinberg School of Medicine), and Dr. Raquel Magri, M.D. (Colegio Iberoamericano de Adicciones at Hospital Pereira Rossell, Montevideo, Uruguay), with expert Consultation from Dr. Phillip May, Ph.D. (University of North Carolina, Gillings School of Global Public Health, Kannapolis, NC). “We are very interested in discerning the detailed characteristics of maternal risk and protection for fetal alcohol spectrum disorders in this unique binge drinking population that will guide prevention and intervention in the future,” said Dr. May, “This research will help to ensure healthier babies in the future, not just in Montevideo and Uruguay, but in other countries with similar risk profiles and similar social and public health conditions. ”
This work will focus on a cross-sectional study of 1500 women, ages 18 years and older, and their newborns in the city of Montevideo, Uruguay. Previous work in public health care hospitals in Montevideo, Uruguay documented high rates of alcohol use during pregnancy (60%) as well as PEth levels in newborns (79%).  “The country has a high prevalence of alcohol consumption among young women, including those who are pregnant and in low and middle-low socioeconomic and educational status, whose babies might be more at risk for FASD,” said Dr. Magri, “The results will help to start the actions in a strategy to lessen this consumption.”
Alcohol use in the previous studies was documented through self-report surveys of pregnant women. The current undertaking will also examine PEth levels in mothers and investigate the correlation between maternal and neonatal PEth measurements. PEth is a newer biomarker that detects episodic heavy drinking (5 or more drinks in one sitting) for up to the last 30 days. PEth testing is 100% specific in detecting recent alcohol use with no known false positives.
A strong correlation between maternal and neonatal PEth levels would offer the possibility of a universally available tool that will prevent undetected cases of prenatal alcohol exposure, increasing the potential for newborns to receive early developmental interventions when necessary and prevent them from slipping through the cracks. “A new biomarker for alcohol, more accurate and easy to collect will probably present more positive results in a population with highest prevalence,” said Dr. Magri, “There is strong experience with this group of researchers, who have worked together in this area in three previous studies.” The future of neonatal alcohol screening is promising.
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