Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

Detalhes bibliográficos
Autor(a) principal: Wehby, George L.
Data de Publicação: 2006
Outros Autores: Castilla, Eduardo E., Goco, Norman, Rittler, Monica, Cosentino, Viviana, Javois, Lorette, McCarthy, Ann Marie, Bobashev, Georgiy, Litavecz, Stephen, Mariona, Alejandra, Dutra, Graca, López-Camelo, Jorge S., Orioli, Iêda M., Murray, Jeffrey C.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/39769
Resumo: University of Iowa. Department of Health Management and Policy. Iowa City, USA.
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spelling Wehby, George L.Castilla, Eduardo E.Goco, NormanRittler, MonicaCosentino, VivianaJavois, LoretteMcCarthy, Ann MarieBobashev, GeorgiyLitavecz, StephenMariona, AlejandraDutra, GracaLópez-Camelo, Jorge S.Orioli, Iêda M.Murray, Jeffrey C.2020-02-06T13:47:33Z2020-02-06T13:47:33Z2006WEHBY, George L. et al. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatrics, v. 6, n. 9, p. 1-9, Mar. 2006.1471-2431https://www.arca.fiocruz.br/handle/icict/3976910.1186/1471-2431-6-9engBMCAtendimento pediátricoMetodologiaEstudo intervencionistaCriançasFissura labiopalatinaPediatric careMethodologyInterventional studyCleft lipPalateAmérica do SulDescription of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversity of Iowa. Department of Health Management and Policy. Iowa City, USA.Latin American Collaborative Study of Congenital Malformations. Centro de Educación Médica e Investigaciones Clínicas. Buenos Aires, Argentina / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.RTI International. Research Triangle Park, USA.ECLAMC, Maternidad Ramón Sardá. Buenos Aires, Argentina.Latin American Collaborative Study of Congenital Malformations. Centro de Educación Médica e Investigaciones Clínicas. Buenos Aires, Argentina.Center for Developmental Biology and Perinatal Medicine. National Institute of Child Health and Human Development. Bethesda, USA.University of Iowa. College of Nursing. Iowa City, USA.RTI International. Research Triangle Park, USA.RTI International. Research Triangle Park, USA.Latin American Collaborative Study of Congenital Malformations. Centro de Educación Médica e Investigaciones Clínicas. Buenos Aires, Argentina.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. ECLAMC. Rio de Janeiro, RJ, Brasil.Instituto Multidisciplinario de Biologia Celular. La Plata, Argentina.Universidade Federal do Rio de Janeiro. Departamento de Genética. Rio de Janeiro, RJ, Brasil.University of Iowa. Department of Pediatrics. Iowa City, USA.Background: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. Methods/Design: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. Discussion: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/39769/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALEduardoCastilla_GraçaDutra_etal_IOC_2006.pdfEduardoCastilla_GraçaDutra_etal_IOC_2006.pdfapplication/pdf276003https://www.arca.fiocruz.br/bitstream/icict/39769/2/EduardoCastilla_Gra%c3%a7aDutra_etal_IOC_2006.pdfa8d977f59628e4374cf6a3c99353f521MD52TEXTEduardoCastilla_GraçaDutra_etal_IOC_2006.pdf.txtEduardoCastilla_GraçaDutra_etal_IOC_2006.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
title Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
spellingShingle Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
Wehby, George L.
Atendimento pediátrico
Metodologia
Estudo intervencionista
Crianças
Fissura labiopalatina
Pediatric care
Methodology
Interventional study
Cleft lip
Palate
América do Sul
title_short Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
title_full Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
title_fullStr Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
title_full_unstemmed Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
title_sort Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]
author Wehby, George L.
author_facet Wehby, George L.
Castilla, Eduardo E.
Goco, Norman
Rittler, Monica
Cosentino, Viviana
Javois, Lorette
McCarthy, Ann Marie
Bobashev, Georgiy
Litavecz, Stephen
Mariona, Alejandra
Dutra, Graca
López-Camelo, Jorge S.
Orioli, Iêda M.
Murray, Jeffrey C.
author_role author
author2 Castilla, Eduardo E.
Goco, Norman
Rittler, Monica
Cosentino, Viviana
Javois, Lorette
McCarthy, Ann Marie
Bobashev, Georgiy
Litavecz, Stephen
Mariona, Alejandra
Dutra, Graca
López-Camelo, Jorge S.
Orioli, Iêda M.
Murray, Jeffrey C.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Wehby, George L.
Castilla, Eduardo E.
Goco, Norman
Rittler, Monica
Cosentino, Viviana
Javois, Lorette
McCarthy, Ann Marie
Bobashev, Georgiy
Litavecz, Stephen
Mariona, Alejandra
Dutra, Graca
López-Camelo, Jorge S.
Orioli, Iêda M.
Murray, Jeffrey C.
dc.subject.other.pt_BR.fl_str_mv Atendimento pediátrico
Metodologia
Estudo intervencionista
Crianças
Fissura labiopalatina
topic Atendimento pediátrico
Metodologia
Estudo intervencionista
Crianças
Fissura labiopalatina
Pediatric care
Methodology
Interventional study
Cleft lip
Palate
América do Sul
dc.subject.en.pt_BR.fl_str_mv Pediatric care
Methodology
Interventional study
Cleft lip
Palate
América do Sul
description University of Iowa. Department of Health Management and Policy. Iowa City, USA.
publishDate 2006
dc.date.issued.fl_str_mv 2006
dc.date.accessioned.fl_str_mv 2020-02-06T13:47:33Z
dc.date.available.fl_str_mv 2020-02-06T13:47:33Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv WEHBY, George L. et al. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatrics, v. 6, n. 9, p. 1-9, Mar. 2006.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/39769
dc.identifier.issn.pt_BR.fl_str_mv 1471-2431
dc.identifier.doi.none.fl_str_mv 10.1186/1471-2431-6-9
identifier_str_mv WEHBY, George L. et al. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatrics, v. 6, n. 9, p. 1-9, Mar. 2006.
1471-2431
10.1186/1471-2431-6-9
url https://www.arca.fiocruz.br/handle/icict/39769
dc.language.iso.fl_str_mv eng
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dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
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