Case-Control Study of Hemifacial Microsomia (HFM) and Drug Use


  • To test the hypothesis that hemifacial microsomia (HFM) risk is increased by maternal use of vasoconstrictive decongestants while controlling for the effects of frequency, dose, type and indication;
  • To test the hypothesis that HFM risk is increased by maternal use of other vasoactive exposures, including aspirin, ibuprofen, caffeinated coffee, alcohol, and smoking;
  • To examine the relation between HFM risk and maternal exposure to other medications, illnesses, or specific nutrient deficiencies or excesses; and
  • To collect and store buccal cell samples for future analyses of the relation between HFM risk and possible genetic marker/exposure interactions.


Cases less 12 months of age are identified from craniofacial centers in over twenty cities across the U.S. and Canada . Controls are identified by case infant’s primary physician and will comprise the next three infants born after the case. Mothers of cases and controls will be interviewed by telephone within 15 months after the infant’s date of birth. The standardized questionnaire asks in detail about demographic factors; reproductive, medical and pregnancy illness histories; medication use; behaviors (smoking, alcohol, coffee); and nutrition. Buccal cell samples are collected from cases, controls, and their parents and sent to Slone for storage. Standardized photographs are taken and the medical record of each case infant will be reviewed for HFM classification by Dr. John Mulliken, Children’s Hospital, Boston.

Investigators and Study Staff

Martha M. Werler, Sc.D., Principal Investigator
Catherine Hayes, D.M.D., D.M.Sc., Co-Investigator
Allen A. Mitchell, M.D., Co-Investigator

Study Details

Source of Funding:

National Institutes of Dental Research and Child Health and Human Development

Study Period:

July 1997 to June 2001