At present, there are few data applicable to humans on the risks of intermittent alcohol use (binge drinking) in pregnancy. Such information is urgently needed by medical professionals counseling pregnant women, but for both ethical and practical reasons cannot be obtained from human studies. An alternate primate model is necessary. A recent pilot project demonstrating a binge model for fetal alcohol syndrome in the pigtailed macaque (Macaca nemestrina) found severe teratogenic effects in the animal exposed to 4.1 g/kg of ethanol once per week from mid-first trimester to term. Moderate effects were found in one of two animals exposed to 2.5 g/kg of ethanol over the same gestational period. In this study 39 additional females and their resultant infants will be evaluated. When added to the pilot project infants, there will be 6 groups of 7 animals each exposed to 0, 0.3, 0.6, 1.2, 2.5, or 4.1 g/kg of ethanol once/week throughout gestation. The mothers will be given the ethanol by gavage weekly from the first week after conception to term. Maternal weight gain, dietary intake and general health will be closely monitored. Serum ethanol degradation curves will be obtained after each dosage and after parturition. The infants will be observed for 6 months. Physical examinations for major and minor malformations at birth and at 6 months will be recorded. Roentgenograms and photographs will be obtained. A standardized battery of developmental and psychological tests will be applied. A complete autopsy at 6 months with extensive neuroanatomic and neurochemical studies will be done. The study will provide much needed information on variation in ethanol metabolism throughout pregnancy and when non-pregnant as well as on the dose-response curve for each physical, behavioral and neuroanatomic-neurochemical characteristic of the infant that is affected by periodic exposure to alcohol during gestation.
