Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Envir... | NCT00340977

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

NCT00340977

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Status

Completed

Last Update Posted

Nov 20, 2019Actual

Enrollment

4,091Actual

Phase

Not provided

Conditions

Birth Defects
Cleft Palate
Cleft Lip

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OH96-E-N006

Status Module

Record Verification Date

Nov 18, 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 1995

Primary Completion Date

Not provided

Completion Date

Nov 18, 2019

First Submitted Date

Jun 19, 2006

First Submission Date that Met QC Criteria

Jun 19, 2006

First Posted Date

Jun 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2019

Last Update Posted Date

Nov 20, 2019Actual

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,091Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case-Control Parent-Triad		Norwegian infants born with cleft lip or palate over a 5 year period

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of genetic alleles	Facial Clefts	Ascertained within first year after birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allen Wilcox, M.D.	National Institute of Environmental Health Sciences (NIEHS)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian Institute of Public Health		Bergen			Norway
University of Bergen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7268309	Background	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.
663563	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.

ID	Term
D000013	Congenital Abnormalities
D002972	Cleft Palate
D002971	Cleft Lip
D020022	Genetic Predisposition to Disease

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases