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Clinical Trials: Neonatal (Newborn)
IRB No. 14-197-6 (Dr. Damion Grasso, PI): The Influence of Prenatal Exposure to Stress on the DNA Methylation Status of FKBP5 in Newborns
Understanding the impact of prenatal maternal stress (PNMS) on child development is needed to identify at-risk children at the earliest possible time point and to design and implement effective interventions. One of the genes involved in the stress response pathway is FKBP5 (FK506 binding protein 5). The FKBP5 protein is a critical component of a negative feedback loop that functions to terminate the stress response at the cellular level by decreasing ligand binding and blocking translocation of the glucocorticoid receptor complex into the nucleus. Emerging data on FKBP5 suggests one potential pathway by which early, chronic childhood trauma exposure may lead to emotional and behavioral problems later in life. This study seeks to understand how the in utero exposure to domestic violence can impact ability of this gene to function properly.
IRB No. 17-180H-6.2 (Dr. Cheryl Oncken, PI): Electronic Cigarette Use During Pregnancy HHC-2017-0208
An observational, longitudinal, prospective cohort study of 375 women (125 women who smoke conventional cigarettes exclusively during pregnancy, 125 who use e-cigs and 125 dual users). Background: Maternal smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States causing 16% low birth weight babies, 6% of premature deliveries, and 6% of preterm related deaths. Quitting smoking is the best option to improve maternal and child health, and smoking reduction is also beneficial. However, an increasing number of pregnant smokers may be using electronic cigarettes (e-cigs) as a substitute for or in conjunction with cigarette smoking. Rationale for this study: E-cigs are an emerging public health issue. They may have a net benefit or risk. A need exists to evaluate the impact of e-cigs in vulnerable populations such as pregnant women. The information about the potential risks and benefits is needed to adequately inform pregnant women and health care providers who counsel their patients. Study Design: This is an observational, longitudinal, prospective cohort study. Study Population and Sample Size: Pregnant smokers who exclusively smoke conventional cigarettes, or who use e-cigs. A total of 375 subjects (125 who smoke conventional cigarettes and 125 who use e-cigs, and 125 dual users) will be enrolled across six sites (UCHC, HH, Baystate Medical Center, University of Colorado, Denver Health, and University of East Tennessee). Major Study Interventions: Not a treatment study. Observational only. Providing written smoking cessation education materials and referral to state Quitline if needed. Main Outcome Measures/Analyses: To determine if e-cigarettes use leads to lower exposure to toxicants in pregnant women relative to those pregnant smokers who smoke conventional cigarettes. Hypotheses, aims and objectives: Hypothesis 1: We hypothesize that women who smoke conventional cigarettes will have higher urine NNAL and serum cotinine & benzene levels compared to users of e-cigs (dual users or exclusive users). Aims / objectives 1: To compare the overall toxicant exposure in pregnant women who use e-cigs to women who smoke conventional cigarettes Hypothesis 2: We hypothesize that infants born to women who smoke conventional cigarettes will have higher levels of NNAL, benzene/SPMA and cotinine compared to infants born to users of e-cigs (dual or exclusive users). Aim/Objective 2: To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes Hypothesis 3: We hypothesize that maternal urine for NNAL will be predictive of birth weight, and that this effect will be mediated by inflammatory processes, measured using markers of inflammation [high sensitivity C-reactive protein (hs CRP) and intercellular adhesion molecule (ICAM-1)]. Any additional effect of benzene/SPMA will be explored. Aim/Objective 3: To explore potential mechanisms by which toxicants could influence birth weight.