Oral cleft prevention program (OCPP)

BMC Pediatrics

Study Protocol

Lorette Javois¹  Danilo Moretti-Ferreira²  Carla Padovani³  Fernanda Queiros³  Camilla Vila Nova Guimaraes³  Temis Felix⁴  Antonio Richieri-Costa⁵  Rui Pereira⁶  Hrishikesh Chakraborty⁷  Norman Goco⁷  Tyler Hartwell⁷  Steve Litavecz⁷  Jeffrey C Murray⁸  George L Wehby⁸ 

[1]Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA

[2]Genetic Counseling Service – Bioscience Institute, São Paulo State University, Botucatu, Sao Paulo, Brazil

[3]Hospital Santo Antônio- Centrinho: Obras Sociais Irmã Dulce, Salvador, Bahia, Brazil

[4]Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

[5]Hospital de Reabilitação de Anomalias Craniofaciais, Bauru, Sao Paulo, Brazil

[6]Instituto Materno Infantil Prof. Fernando Figueira, Recife, Pernambuco, Brazil

[7]RTI International, Durham, NC, USA

[8]University of Iowa, Iowa City, IA, USA

关键词: Oral clefts;    Cleft lip;    Cleft palate;    Craniofacial anomalies;    Congenital anomalies;    Birth defects;    Folic acid;    Vitamins;    Prevention;   

DOI  :  10.1186/1471-2431-12-184

 received in 2012-10-05, accepted in 2012-11-13,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundOral 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/designThis 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.DiscussionThe 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.ClinicalTrials.gov IdentifierNCT00397917

【 授权许可】

Unknown   
© Wehby et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.