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
Source of Funding:
National Institutes of Dental Research and Child Health and Human Development
July 1997 to June 2001
- Werler MM, Sheehan JE, Mitchell AA. Diabetes, body mass index, vitamin supplementation and anotia/microtia. Presented at Teratology Society Annual Meeting. Vancouver, BC, June 30, 2004.
- Werler MM. Do vasoactive exposures and vascular events affect the development of hemifacial microsomia?. Presented at the American Cleft Palate Craniofacial Association Meeting. Chicago, IL, March 17, 2004.
- Werler MM, Hayes C, Sheehan JE, Mitchell AA. Military service, Gulf War service, and hemifacial microsomia. Presented at Teratology Society Annual Meeting. Philadelphia, PA, June 25, 2003.
- Werler MM, Sheehan JE, Hayes C, Mulliken JB, Mitchell AA. Case-control study of hemifacial microsomia: preliminary findings. Presented at American Cleft Palate Craniofacial Association Meeting. Seattle, WA, May 3, 2002.
- Cloonan YK, Kifle Y, Davis S, Speltz ML, Werler MM, Starr JR. Sleep outcomes in children with hemifacial microsomia and controls: a follow-up study. Pediatrics 2009;124(2):e313-21. doi: 10.1542/peds.2008-3488. PMCID: PMC2739665.
- Werler MM, Sheehan JE, Mitchell AA. Gulf war veterans and hemifacial microsomia. Birth Defects Res A Clin Mol Teratol 2005;73:50-2.
- Werler MM, Sheehan JE, Hayes C, Padwa BL, Mitchell AA, Mulliken JB. Demographic and reproductive factors associated with hemifacial microsomia. Cleft Palate Craniofac J 2004;41:494-500.
- Werler MM, Sheehan JE, Hayes C, Mitchell AA, Mulliken JB. Vasoactive exposures, vascular events, and hemifacial microsomia. Birth Defects Res A Clin Mol Teratol 2004;70(6):389-95.