Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case-Control Parent-Triad Norwegian infants born with cleft lip or palate over a 5 year period |
Outcome Measures
Primary Outcome Measures
- Identification of genetic alleles [Ascertained within first year after birth]
Facial Clefts
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Norwegian Institute of Public Health | Bergen | Norway | ||
| 2 | University of Bergen | Bergen | Norway |
Sponsors and Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
Investigators
- Principal Investigator: Allen Wilcox, M.D., National Institute of Environmental Health Sciences (NIEHS)
Study Documents (Full-Text)
None provided.More Information
Publications
- Abyholm FE, Borchgrevink HC, Eskeland G. Cleft lip and palate in Norway. III. Surgical treatment of CLP patients in Oslo 1954-75. Scand J Plast Reconstr Surg. 1981;15(1):15-28.
- Abyholm FE. Cleft lip and palate in a Norwegian population. II. A numerical study of 1555 CLP-patients admitted for surgical treatment 1954-75. Scand J Plast Reconstr Surg. 1978;12(1):35-43.
- Abyholm FE. Cleft lip and palate in Norway. I. Registration, incidence and early mortality of infants with CLP. Scand J Plast Reconstr Surg. 1978;12(1):29-34.
- 999996006
- OH96-E-N006