An observational study in Birth Defects, Cleft Palate and Cleft Lip, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 2 sites in Norway. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
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.
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.
993 studies on the registry are indexed under Congenital Abnormalities; 174 are open to participants now.
This study's enrollment of 4,091 is above the median of 153 across 449 observational studies indexed under Congenital Abnormalities.
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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.
Norwegian infants born with cleft lip or palate over a 5 year period
Identification of genetic alleles
Facial Clefts
Time frame: Ascertained within first year after birth
The record gives a start of Sep 1995 and a completion of Nov 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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National Institute of Environmental Health Sciences (NIEHS) →