Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)

Cleft Palate Clinical Trial

Official title:

Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00340977
• Other study ID #: 999996006
• Secondary ID: OH96-E-N006
• Status: Completed
• Start date: September 6, 1995
• Est. completion date: November 18, 2019

Study information

• Verified date: November 18, 2019
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4091
• Est. completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Birth Defects
• Cleft Lip
• Cleft Palate
• Congenital Abnormalities

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Bergen
Norway	University of Bergen	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genetic alleles	Facial Clefts	Ascertained within first year after birth