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

NCT00340977 | Completed

• 2 other identifiers: 999996006OH96-E-N006
• Study Type: observational
• Target: 4,091
• Locations: 1 country
• Sites: 2

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.

Conditions

Birth Defects; Cleft Palate; Cleft Lip

Keywords

Birth Defects; Cleft Lip and Palate; Genetic Susceptibility

Outcome Measures

Primary Outcomes (1)

• Identification of genetic alleles

  Facial Clefts

  Ascertained within first year after birth

Study Arms (1)

Case-Control Parent-Triad

Norwegian infants born with cleft lip or palate over a 5 year period

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

Norwegian Institute of Public Health

Bergen, Norway

Location

University of Bergen

Bergen, Norway

Location

Related 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. doi: 10.3109/02844318109103407. No abstract available.

  PMID: 7268309 BACKGROUND

• 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. doi: 10.3109/02844317809010478. No abstract available.

  PMID: 663563 BACKGROUND

• 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. doi: 10.3109/02844317809010477. No abstract available.

  PMID: 566463 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities; Cleft Palate; Cleft Lip; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Lip Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allen Wilcox, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: September 6, 1995
• Study Completion: November 18, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11-18

Locations

NO (2)