Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00340977
Other study ID # 999996006
Secondary ID OH96-E-N006
Status Completed
Phase
First received
Last updated
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
Health authority
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
Est. primary completion date
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05166408 - Fistiulation Rate Following Primary Cleft Repair≤ N/A
Recruiting NCT03839290 - Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Recruiting NCT01867632 - Acellular Dermal Matrix in Primary Furlow Palatoplasty N/A
Completed NCT02900014 - Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate N/A
Withdrawn NCT02953145 - The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery Phase 4
Completed NCT04725370 - Characterization of Cleft Lip and Palate Conditions in Guatemala
Withdrawn NCT03572907 - Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.
Enrolling by invitation NCT02702869 - Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Completed NCT02583100 - Improving Outcomes in Cleft Palate Surgery N/A
Recruiting NCT06072495 - Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI N/A
Completed NCT04718558 - Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair
Not yet recruiting NCT05357092 - Effects of AlignBabyCleft (ABaCleft) N/A
Completed NCT01500109 - Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair N/A
Completed NCT01252264 - FaceBase Biorepository
Completed NCT00397917 - Oral Cleft Prevention Program Phase 3
Enrolling by invitation NCT03632044 - Evaluation of Trigeminal Nerve Blockade Phase 4
Completed NCT04277273 - Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris N/A
Completed NCT05405738 - Cleft Palate Technique and Maxillary Growth
Completed NCT03170505 - Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage N/A
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A