Birth Defects, Cleft Lip, Cleft Palate
Conditions
Keywords
Birth Defects, Cleft Lip and Palate, Genetic Susceptibility
Brief summary
This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.
Detailed description
This proposal describes a population-based case-control study of all Norwegian infants born with cleft lip or palate over a five-year period. The study will be jointly supported by the U.S. National Institute of Environmental Health Sciences (NIEHS), and the Norwegian National Institute of Public Health (SIFF) and Medical Birth Registry of Norway (MBR). Cases will be identified through the two surgery clinics that treat all clefts in Norway. Controls will be randomly selected from all live births through the MBR. Mothers will complete two selfadministered questionnaires; one regarding exposures before and during pregnancy, the other their diet during their early months of pregnancy. Biological specimens for DNA testing (blood samples, buccal swabs) will be collected from cases, controls and mothers in order to describe possible gene-environment interactions. With 750 cases and 1100 controls, this will be one of the largest and most complete field studies of facial clefting yet conducted.
Interventions
None listed
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: We expect to enroll about 150 infants with cleft lip or palate annually for five years (550 with cleft lip with or without cleft palate, and 200 with cleft palate alone) Controls will be chosen randomly from all Norwegian live-births through the Medical Birth Registry.
Exclusion criteria
There will be no exclusion by race, sex or ethnic group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of genetic alleles | Ascertained within first year after birth | Facial Clefts |
Countries
Norway
Outcome results
None listed