Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00340977
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date September 6, 1995
Completion date November 18, 2019

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