RESUMO
BACKGROUND: Several countries have implemented mandatory folic acid fortification of wheat flour and selected grain products to increase the folate intake of reproductive-aged women. Brazil implemented a folic acid fortification program in 2004. No previous studies have examined folate differences among Brazilian women following the mandate. OBJECTIVE: We evaluate differences in serum and red blood cell (RBC) folate concentrations between two samples of women of childbearing age from selective communities in Brazil, one tested before (N = 116) and the other after the mandate (N = 240). METHODS: We compared the baseline folate levels of women enrolled in a prevention study shortly before the fortification mandate was implemented, to baseline levels of women from the same communities enrolled in the same study shortly after fortification began. The participants were women enrolled in a folate supplementation clinical trial, at a hospital specializing in treating craniofacial anomalies in the city of Bauru from January 29, 2004 to April 27, 2005. We only compared baseline folate levels before the women received oral cleft prevention program (OCPP) folic acid supplements. RESULTS: Women enrolled after the fortification mandate had higher means of serum folate (20.3 versus 11.2 nmol/L; p < 0.001) and RBC folate (368.3 versus 177.6 nmol/L; p < 0.001) than women enrolled before the mandate. Differences in folate levels between the two groups remained after adjusting for several co-variables. CONCLUSIONS: The results suggest that serum and RBC folate levels among women of childbearing age increased after implementing the folic acid fortification mandate in Brazil.
Assuntos
Ácido Fólico/sangue , Ácido Fólico/farmacologia , Alimentos Fortificados , Adulto , Brasil , Relação Dose-Resposta a Droga , Feminino , Ácido Fólico/administração & dosagem , Humanos , Adulto JovemRESUMO
OBJECTIVES: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. PATIENTS AND METHODS: The study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid supplementation groups: 0.4 and 4 mg per day before pregnancy and throughout the first trimester. The infant outcome data were based on 234 live births. In addition to oral cleft recurrence, several secondary outcomes were compared between the two folic acid groups. Cleft recurrence rates were also compared to historic recurrence rates. RESULTS: The oral cleft recurrence rates were 2.9% and 2.5% in the 0.4 and 4 mg groups, respectively. The recurrence rates in the two folic acid groups both separately and combined were significantly different from the 6.3% historic recurrence rate post the folic acid fortification program for this population (p = 0.0009 when combining the two folic acid groups). The rate of cleft lip with palate recurrence was 2.9% in the 0.4 mg group and 0.8% in the 4 mg group. There were no elevated fetal growth complications in the 4 mg group compared to the 0.4 mg group. CONCLUSIONS: The study is the first double-blinded randomized clinical trial (RCT) to study the effect of high dosage folic acid supplementation on isolated oral cleft recurrence. The recurrence rates were similar between the two folic acid groups. However, the results are suggestive of a decrease in oral cleft recurrence compared to the historic recurrence rate. A RCT is still needed to identify the effect of folic acid on oral cleft recurrence given these suggestive results and the supportive results from previous interventional and observational studies, and the study offers suggestions for such future studies. The results also suggest that high dosage folic acid does not compromise fetal growth.
Assuntos
Fenda Labial/prevenção & controle , Fissura Palatina/prevenção & controle , Desenvolvimento Fetal/efeitos dos fármacos , Ácido Fólico/administração & dosagem , Complexo Vitamínico B/administração & dosagem , Adulto , Brasil , Suplementos Nutricionais , Método Duplo-Cego , Feminino , Humanos , Gravidez , Adulto JovemRESUMO
OBJECTIVE: To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. STUDY DESIGN: This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. RESULTS: MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164). CONCLUSIONS: This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.
Assuntos
Asfixia/terapia , Deficiências do Desenvolvimento/diagnóstico , Intervenção Educacional Precoce/métodos , Desenvolvimento Infantil , Transtornos Cognitivos/prevenção & controle , Países em Desenvolvimento , Feminino , Humanos , Índia , Recém-Nascido , Masculino , Paquistão , Transtornos Psicomotores/prevenção & controle , Ressuscitação , População Rural , Inquéritos e Questionários , Resultado do Tratamento , ZâmbiaRESUMO
OBJECTIVE: To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment. STUDY DESIGN: Infants unresponsive to stimulation who received bag and mask ventilation at birth in a resuscitation trial and infants who did not require any resuscitation were randomized to early neurodevelopmental intervention or control groups. Infants were examined by trained neurodevelopmental evaluators masked to both their resuscitation history and intervention group. The 12-month neurodevelopmental outcome data for both resuscitated and non-resuscitated infants randomized to the control groups are reported. RESULTS: The study provided no evidence of a difference between the resuscitated infants (n = 86) and the non-resuscitated infants (n = 115) in the percentage of infants at 12 months with a Mental Developmental Index <85 on the Bayley Scales of Infant Development-II (primary outcome; 18% versus 12%; P = .22) and in other neurodevelopmental outcomes. CONCLUSIONS: Most infants who received resuscitation with bag and mask ventilation at birth have 12-month neurodevelopmental outcomes in the reference range. Longer follow-up is needed because of increased risk for neurodevelopmental impairments.
Assuntos
Deficiências do Desenvolvimento/epidemiologia , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Ressuscitação/efeitos adversos , Ressuscitação/métodos , Desenvolvimento Infantil/fisiologia , Países em Desenvolvimento , Deficiências do Desenvolvimento/diagnóstico , Feminino , Humanos , Incidência , Índia/epidemiologia , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Deficiências da Aprendizagem/diagnóstico , Deficiências da Aprendizagem/epidemiologia , Masculino , Transtornos Mentais/diagnóstico , Transtornos Mentais/epidemiologia , Testes Neuropsicológicos , Paquistão/epidemiologia , Valores de Referência , Medição de Risco , População Rural , Índice de Gravidade de Doença , Análise de Sobrevida , Zâmbia/epidemiologiaRESUMO
BACKGROUND: Cleft lip and/or palate (CL/P) increase mortality and morbidity risks for affected infants especially in less developed countries. This study aimed at assessing the effects of systematic pediatric care on neonatal mortality and hospitalizations of infants with cleft lip and/or palate (CL/P) in South America. METHODS: The intervention group included live-born infants with isolated or associated CL/P in 47 hospitals between 2003 and 2005. The control group included live-born infants with CL/P between 2001 and 2002 in the same hospitals. The intervention group received systematic pediatric care between the 7th and 28th day of life. The primary outcomes were mortality between the 7th and 28th day of life and hospitalization days in this period among survivors adjusted for relevant baseline covariates. RESULTS: There were no significant mortality differences between the intervention and control groups. However, surviving infants with associated CL/P in the intervention group had fewer hospitalization days by about six days compared to the associated control group. CONCLUSIONS: Early systematic pediatric care may significantly reduce neonatal hospitalizations of infants with CL/P and additional birth defects in South America. Given the large healthcare and financial burden of CL/P on affected families and the relatively low cost of systematic pediatric care, improving access to such care may be a cost-effective public policy intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00097149.