Oral cleft prevention program (OCPP)

dc.contributorUniversidade Estadual Paulista (UNESP)
dc.creatorWehby, George L.
dc.creatorGoco, Norman
dc.creatorMoretti-Ferreira, Danilo
dc.creatorFelix, Temis
dc.creatorRichieri-Costa, Antonio
dc.creatorPadovani, Carla
dc.creatorQueiros, Fernanda
dc.creatorNova Guimaraes, Camilla Vila
dc.creatorPereira, Guimaraes Rui
dc.creatorLitavecz, Steve
dc.creatorHartwell, Tyler
dc.creatorChakraborty, Hrishikesh
dc.creatorJavois, Lorette
dc.creatorMurray, Jeffrey C.
dc.date2014-05-20T13:50:30Z
dc.date2014-05-20T13:50:30Z
dc.date2012-11-26
dc.date.accessioned2017-04-05T21:03:36Z
dc.date.available2017-04-05T21:03:36Z
dc.identifierBmc Pediatrics. London: Biomed Central Ltd., v. 12, p. 33, 2012.
dc.identifier1471-2431
dc.identifierhttp://hdl.handle.net/11449/18020
dc.identifier10.1186/1471-2431-12-184
dc.identifierWOS:000313076900001
dc.identifierWOS000313076900001.pdf
dc.identifier0000-0002-9256-7623
dc.identifierhttp://dx.doi.org/10.1186/1471-2431-12-184
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/864362
dc.descriptionBackground: Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted.Methods/design: This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with nonsyndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4mg, 0.4 mg) to that of a historical control group. The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings.Discussion: The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women.
dc.languageeng
dc.publisherBiomed Central Ltd.
dc.relationBMC Pediatrics
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectOral clefts
dc.subjectCleft lip
dc.subjectCleft palate
dc.subjectCraniofacial anomalies
dc.subjectCongenital anomalies
dc.subjectBirth defects
dc.subjectFolic acid
dc.subjectVitamins
dc.subjectPrevention
dc.titleOral cleft prevention program (OCPP)
dc.typeOtro


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