Svangerskap, Arv, Og Miljo (Pregnancy,… | Clinical Trial

Key information

Conditions

Birth Defects Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwegian Institute of Public Health, Bergen, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Identification of genetic alleles

Time frame: Ascertained within first year after birth

Facial Clefts

Sponsors and collaborators

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS)

Nih

Registry information

Important dates

Study start: 1995
Study completion: 2019
First posted: Jun 21, 2006
Registry last updated: Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed