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The Maternal Lifestyle Study (MLS) was the largest of the NIH longitudinal studies of children with prenatal cocaine exposure (PCE). MLS was a longitudinal multi-site observational study of the long-term effects of in-utero exposure to cocaine on child development. MLS was conducted at four geographically diverse, collaborating university centers (Wayne State University, University of Tennessee at Memphis, University of Miami, and Brown University). Participants were identified during the newborn period while in the hospital. The MLS began enrollment of a longitudinal birth cohort of 1,388 infant/mother dyads in 1993. Subjects in the follow-up were seen from 1 month of age through 16 years of age. The overall purpose of the study was to investigate the effects of drug use during pregnancy on acute neonatal events and long-term physical health, social, behavioral and neurodevelopmental outcomes. The study included five phases of data collection. The first phase examined acute effects of maternal substance use on infant health outcomes at birth. The four subsequent follow-up phases examined development across the following periods: Phase II -- 1-36 months; Phase III -- 4-7 years; Phase IV -- 8-11 years; Phase V -- 12-16 years. In Phase I, the study screened 19,079 infants between May 1993 and May 1995. Mothers at these centers were enrolled in the study within 24 hours after delivery. Initial screening included the mother's labor and delivery chart, the newborn admission chart, and a meconium sample. Infant meconium was collected and samples were express shipped to a central laboratory for analysis of metabolites of illicit drugs. Additionally, a drug use questionnaire that addressed the mother's use during pregnancy of nicotine, alcohol, marijuana, cocaine, opiates, and other illicit drugs was given by research staff that were trained and certified in the reliable administration of all of the study interviews. A mother-child dyad was considered exposed if a mother admitted to using cocaine during pregnancy and/or there was a positive meconium assay for cocaine metabolites including gas chromatography/mass spectrometry confirmation. Nonexposed children were those who were born to mothers who denied cocaine use, confirmed by negative meconium test results. Acute outcomes evaluated in Phase I included: central nervous system (CNS) and autonomic nervous system (ANS) findings and symptoms, abruption placenta, fetal growth retardation, congenital malformations, respiratory distress syndrome, chronic lung disease, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, and periventricular leukomalacia. From the initial Phase I cohort of 8,627 dyads, 1,388 participants for the longitudinal follow-up were recruited at a 1-month visit. The sample included a cohort of exposed infants (n = 658) who were group matched within site with a group of non-exposed comparison infants (n=730) by gestational age categories (32, 33-36, and 36 weeks) and child gender, race, and ethnicity. At the 1-month visit, the biological mother was interviewed for a detailed inventory of her legal and illegal drug use during pregnancy using the Maternal Interview of Substance Use (MISU). Phase II examined the first 36 months of life for the sample of 1,388. Follow-up visits occurred at 1, 4, 7, 9, 12, 18, 24, and 36 months (corrected age). Outcomes examined included physical health, developmental, behavioral, social, and environm,ental outcomes. Phase III followed children at 4, 4.5, 5, 6, and 7 years. In addition to outcomes examined in Phase II, school performance and neurodevelopmental measures of emotional and behavioral self-regulation were also examined. Phase IV covers ages 8, 9, 10, and 11 years of age. Outcomes in this phase were further expanded to include antisocial behavior, onset of substance use, psychopathology, and neuroendocrine function. Phase V assessed children at ages 12, 13, 14, 15, and 16 years of age. The fifth phase of the study has a significant emphasis on psychopathology, school performance, peer relationships, substance use onset and risk taking behaviors, including risky sexual behaviors.