Pregnancy, Heredity, and Environment (Svangerskap, Arv og Miljo)
Social & Scientific Systems conducted this NIEHS population-based, case-control study of all Norwegian newborns with facial clefts born during a 5-year period in collaboration with Norway's National Institute of Public Health (NIPH) and Medical Birth Registry (MBR). All newborn infants born with cleft lip and cleft lip and palate (CL(P)) were referred to the study through the two medical centers in Norway that treat all cleft cases. Controls were randomly sampled from the entire population by the MBR, which maintains records of all newborn babies in Norway. Mothers of selected cases and controls were asked to complete a self-administered questionnaire that assessed the mother's health, exposure, and reproductive history and dietary intake. Norwegian project staff collected biological specimens for DNA testing: baby's PKU blood, buccal swabs from selected case and control family members, and case baby and mother's blood at time of surgery to repair the cleft. Data were abstracted from the mothers' prenatal records, MBR forms, and surgical records of case infants. Working with NIEHS and Norwegian investigators, SSS staff designed the questionnaires and developed field procedures, a study management system, and the protocol for specimen collection, processing, and storage in Norway. Training of the Norwegian staff was conducted by Social & Scientific Systems. Our staff traveled annually to Norway to provide liaison and oversight of study operations. Over the 5-year study period, 550 infants with CL(P), 200 with cleft palate only, and 1,100 controls enrolled in the study. Our laboratory has collaborated with NIEHS' DNA extraction contractor to create and track DNA sets for collaborative use by NIEHS and NIPH.