Oral cleft prevention program (OCPP)
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Outros Autores: | , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
DOI: | 10.1186/1471-2431-12-184 |
Texto Completo: | http://dx.doi.org/10.1186/1471-2431-12-184 http://hdl.handle.net/11449/18020 |
Resumo: | Background: 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. |
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Oral cleft prevention program (OCPP)Oral cleftsCleft lipCleft palateCraniofacial anomaliesCongenital anomaliesBirth defectsFolic acidVitaminsPreventionBackground: 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.NIH/NICHD, Global Network for Women's and Children's Health ResearchNIH/NIDCRUniv Iowa, Iowa City, IA 52242 USASão Paulo State Univ, Biosci Inst, Genet Counseling Serv, Botucatu, SP, BrazilHosp Reabilitacao Anomalias Craniofaciais, Bauru, SP, BrazilHosp Clin Porto Alegre, Porto Alegre, RS, BrazilHosp Santo Antonio Centrinho Obras Sociais Irma D, Salvador, BA, BrazilInst Materno Infantil Prof Fernando Figueira, Recife, PE, BrazilRTI Int, Durham, NC USAEunice Kennedy Shriver Natl Inst Child Hlth & Hum, Bethesda, MD USASão Paulo State Univ, Biosci Inst, Genet Counseling Serv, Botucatu, SP, BrazilNIH/NICHD: U01HD040561NIH/NIDCR: U01 DE017958Biomed Central Ltd.Univ IowaUniversidade Estadual Paulista (Unesp)Universidade de São Paulo (USP)Hosp Clin Porto AlegreHosp Santo Antonio Centrinho Obras Sociais Irma DInst Materno Infantil Prof Fernando FigueiraRTI IntEunice Kennedy Shriver Natl Inst Child Hlth & HumWehby, George L.Goco, NormanMoretti-Ferreira, Danilo [UNESP]Felix, TemisRichieri-Costa, AntonioPadovani, CarlaQueiros, FernandaNova Guimaraes, Camilla VilaPereira, Guimaraes RuiLitavecz, SteveHartwell, TylerChakraborty, HrishikeshJavois, LoretteMurray, Jeffrey C.2014-05-20T13:50:30Z2014-05-20T13:50:30Z2012-11-26info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article33application/pdfhttp://dx.doi.org/10.1186/1471-2431-12-184Bmc Pediatrics. London: Biomed Central Ltd., v. 12, p. 33, 2012.1471-2431http://hdl.handle.net/11449/1802010.1186/1471-2431-12-184WOS:000313076900001WOS000313076900001.pdf0000-0002-9256-7623Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengBMC Pediatrics2.0421,278info:eu-repo/semantics/openAccess2024-01-08T06:23:38Zoai:repositorio.unesp.br:11449/18020Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T22:24:42.548164Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Oral cleft prevention program (OCPP) |
title |
Oral cleft prevention program (OCPP) |
spellingShingle |
Oral cleft prevention program (OCPP) Oral cleft prevention program (OCPP) Wehby, George L. Oral clefts Cleft lip Cleft palate Craniofacial anomalies Congenital anomalies Birth defects Folic acid Vitamins Prevention Wehby, George L. Oral clefts Cleft lip Cleft palate Craniofacial anomalies Congenital anomalies Birth defects Folic acid Vitamins Prevention |
title_short |
Oral cleft prevention program (OCPP) |
title_full |
Oral cleft prevention program (OCPP) |
title_fullStr |
Oral cleft prevention program (OCPP) Oral cleft prevention program (OCPP) |
title_full_unstemmed |
Oral cleft prevention program (OCPP) Oral cleft prevention program (OCPP) |
title_sort |
Oral cleft prevention program (OCPP) |
author |
Wehby, George L. |
author_facet |
Wehby, George L. Wehby, George L. Goco, Norman Moretti-Ferreira, Danilo [UNESP] Felix, Temis Richieri-Costa, Antonio Padovani, Carla Queiros, Fernanda Nova Guimaraes, Camilla Vila Pereira, Guimaraes Rui Litavecz, Steve Hartwell, Tyler Chakraborty, Hrishikesh Javois, Lorette Murray, Jeffrey C. Goco, Norman Moretti-Ferreira, Danilo [UNESP] Felix, Temis Richieri-Costa, Antonio Padovani, Carla Queiros, Fernanda Nova Guimaraes, Camilla Vila Pereira, Guimaraes Rui Litavecz, Steve Hartwell, Tyler Chakraborty, Hrishikesh Javois, Lorette Murray, Jeffrey C. |
author_role |
author |
author2 |
Goco, Norman Moretti-Ferreira, Danilo [UNESP] Felix, Temis Richieri-Costa, Antonio Padovani, Carla Queiros, Fernanda Nova Guimaraes, Camilla Vila Pereira, Guimaraes Rui Litavecz, Steve Hartwell, Tyler Chakraborty, Hrishikesh Javois, Lorette Murray, Jeffrey C. |
author2_role |
author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Univ Iowa Universidade Estadual Paulista (Unesp) Universidade de São Paulo (USP) Hosp Clin Porto Alegre Hosp Santo Antonio Centrinho Obras Sociais Irma D Inst Materno Infantil Prof Fernando Figueira RTI Int Eunice Kennedy Shriver Natl Inst Child Hlth & Hum |
dc.contributor.author.fl_str_mv |
Wehby, George L. Goco, Norman Moretti-Ferreira, Danilo [UNESP] Felix, Temis Richieri-Costa, Antonio Padovani, Carla Queiros, Fernanda Nova Guimaraes, Camilla Vila Pereira, Guimaraes Rui Litavecz, Steve Hartwell, Tyler Chakraborty, Hrishikesh Javois, Lorette Murray, Jeffrey C. |
dc.subject.por.fl_str_mv |
Oral clefts Cleft lip Cleft palate Craniofacial anomalies Congenital anomalies Birth defects Folic acid Vitamins Prevention |
topic |
Oral clefts Cleft lip Cleft palate Craniofacial anomalies Congenital anomalies Birth defects Folic acid Vitamins Prevention |
description |
Background: 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. |
publishDate |
2012 |
dc.date.none.fl_str_mv |
2012-11-26 2014-05-20T13:50:30Z 2014-05-20T13:50:30Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1186/1471-2431-12-184 Bmc Pediatrics. London: Biomed Central Ltd., v. 12, p. 33, 2012. 1471-2431 http://hdl.handle.net/11449/18020 10.1186/1471-2431-12-184 WOS:000313076900001 WOS000313076900001.pdf 0000-0002-9256-7623 |
url |
http://dx.doi.org/10.1186/1471-2431-12-184 http://hdl.handle.net/11449/18020 |
identifier_str_mv |
Bmc Pediatrics. London: Biomed Central Ltd., v. 12, p. 33, 2012. 1471-2431 10.1186/1471-2431-12-184 WOS:000313076900001 WOS000313076900001.pdf 0000-0002-9256-7623 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
BMC Pediatrics 2.042 1,278 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
33 application/pdf |
dc.publisher.none.fl_str_mv |
Biomed Central Ltd. |
publisher.none.fl_str_mv |
Biomed Central Ltd. |
dc.source.none.fl_str_mv |
Web of Science reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1822218586613088256 |
dc.identifier.doi.none.fl_str_mv |
10.1186/1471-2431-12-184 |