Prolonged breastfeeding for 24 months or more and mental health at 6 years of age: evidence from the 2004 Pelotas Birth Cohort Study, Brazil.

BACKGROUND: There is scarce and conflicting evidence on medium- to long-term effects of prolonged breastfeeding on child behavior. METHOD: A population-based birth cohort study started in 2004 in the city of Pelotas, Southern Brazil. Children were followed up at 3, 12, 24, and 48 months and 6 years of age. Breastfeeding duration was determined based on information collected around the time of weaning. Psychiatric disorders were assessed using the Development and Well-Being Assessment (DAWBA). Children who were never breastfed were excluded from the analysis. Crude and adjusted analyses were performed using Poisson regression with robust variance. RESULTS: Data on breastfeeding and mental health at the age of 6 years were available for 3377 children. Prevalence of breastfeeding for 24-35 months and ≥36 months was 16.1% (95% CI: 14.8-17.3) and 8.1% (95% CI: 7.2-9.1), respectively. Prevalence of psychiatric disorders among those who were breastfed for <24 months, 24-35 months and ≥36 months was 12.4% (95% CI: 11.1-13.7), 13.1% (95% CI: 10.4-16.2) and 12.3% (95% CI: 8.7-16.8), respectively. No association was found between breastfeeding for 24 months or more and psychiatric disorders among children aged 6 years both in the crude and adjusted analyses. CONCLUSIONS: In this cohort there was no association between breastfeeding for 24 months or more and an increased prevalence of psychiatric disorders at the age of 6 years. Studies analyzing the medium- and long-term effects of prolonged breastfeeding for 2 years or more are scarce and further research is needed regarding this practice.

Sampling and processing blood samples within the South American Youth/Child cARdiovascular and Environmental (SAYCARE) Study.

Obesity and overweight in children and adolescents is increasing rapidly worldwide; however, scarce data have been reported from South America countries. With the purpose of assessing hyperlipidemia, insulin resistance and chronic inflammation, the evaluation of blood biomarkers such as glucose, lipoproteins and chronic inflammation proteins is required. In the context of the SAYCARE study, in children and adolescents (3 to 18 years) from seven South American cities, our aim was to assess the impact of pre analytical conditions on different biomarkers evaluated in 474 fresh serum samples, in different country centers. We also evaluated the stability according to time and frozen storage within this study across the concordance of the results obtained from the 49 blood samples measured in three different centers. Significant correlations as well as concordance were observed in TG, Total-C, HDL-C and glucose between Buenos Aires and São Paulo. The samples evaluated in Teresina and São Paulo presented similar results, with exception of total cholesterol. We observed acceptable concordance between Buenos Aires vs São Paulo and Teresina vs São Paulo, suggesting that samples could be processed in each of these centers. This concordance is a consequence of the strict pre analytical conditions previously established in the SAYCARE study.

Intra-observer reliability of the anthropometric measurements in South American children and adolescents: the SAYCARE Study.

INTRODUCTION: Introduction: the South American Youth/Child Cardiovascular and Environmental (SAYCARE) feasibility study aims to develop valid and reliable indicators to investigate health-related behavior and nutritional status in children and adolescents. Anthropometric measurements are one of the evaluated indicators in the study. The accuracy of the anthropometric data is very important and relies in the quality of the measurements. Objective: to describe the intra-observer reliability of ten anthropometric measurements: weight, height, circumferences (neck, arm, waist, hip) and skinfolds (triceps, subscapular, biceps and suprailiac) of children and adolescents from six South American cities: Lima, Medellin, Montevideo, Santiago, San Pablo and Teresina. Methods: prior to the study, fieldworkers from the seven centers participated in central training to ensure the application of standardized procedures in the anthropometric measurements. Intra-observer precision, technical error of measurement (TEM) and coefficient of reliability (R) were estimated for each measurement. Results: reliability of weight and height was above 99% in almost all cities. TEM for skinfold thickness was below 1.4 mm in children and 2.13 mm in adolescents, while reliability was above 95% in most of the skinfold measurements. TEM for circumferences was below 1.8 cm in children and 0.64 cm in adolescents, while reliability was above 99% in almost all circumferences. Conclusions: reliability of the anthropometric measurements in this study was high. In comparison with similar European or American studies, the reliability of the measurements taken in our study was, in most cases, similar or even higher.

INTRODUCCIÓN: Introducción: el estudio piloto South American Youth/Child cARdiovascular and Environmental (SAYCARE) tiene como objetivo desarrollar indicadores válidos y confiables para investigar el estado nutricional y las conductas vinculadas a la salud en niños y adolescentes. Uno de estos indicadores son las mediciones antropométricas. La precisión de los datos antropométricos es muy importante y se basa en la calidad con que se toman las mediciones. Objetivos: describir la confiabilidad intraobservador de diez mediciones antropométricas: peso, talla, circunferencias (cuello, brazo, cintura, cadera) y pliegues (trÍceps, subscapular, bÍceps y suprailIaco) de niños y adolescentes de seis ciudades de Sudamérica: Lima, Medellín, Montevideo, Santiago, San Pablo and Teresina. Métodos: previo al estudio, los trabajadores de campo de los seis centros participaron de un entrenamiento centralizado, para asegurar la aplicación de procedimientos estandarizados en la toma de las mediciones antropométricas. Para determinar la precisión intraobservador, se estimó el error técnico de medición (TEM) y el coeficiente de confiabilidad (R) para cada medición. Resultados: la confiabilidad de las medidas de peso y la talla estuvo por encima del 99% en casi todas las ciudades. El TEM para el grosor de los pliegues estuvo debajo de 1,4 mm en los niños y de 2,13 mm en los adolescentes, mientras que la confiabilidad fue superior al 95% en la mayoría de las mediciones de los pliegues. El TEM para las circunferencias estuvo por debajo de 1,8 cm en los niños y de 0,64 cm en los adolescentes, mientras que la confiabilidad fue superior al 99% en casi todas las circunferencias. Conclusiones: la confiabilidad de las mediciones antropométricas en este estudio fue alta. Comparada con estudios similares realizados en Europa y Estados Unidos, la confiabilidad de las medidas tomadas en nuestro estudio es, en la mayoría de los casos, similar o aún más elevada.

Safety and immunogenicity of a combined hepatitis B virus-Haemophilus influenzae type B vaccine comprising a synthetic antigen in healthy adults.

The combined HB-Hib vaccine candidate Hebervac HB-Hib (CIGB, La Habana), comprising recombinant HBsAg and tetanus toxoid conjugate synthetic PRP antigens has shown to be highly immunogenic in animal models. A phase I open, controlled, randomized clinical trial was carried out to assess the safety and immunogenicity profile of this bivalent vaccine in 25 healthy adults who were positive for antibody to HBsAg (anti-HBs). The trial was performed according to Good Clinical Practices and Guidelines. Volunteers were randomly allocated to receive the combined vaccine or simultaneous administration of HB vaccine Heberbiovac-HB and Hib vaccine QuimiHib (CIGB, La Habana). All individuals were intramuscularly immunized with a unique dose of 10 microg HBsAg plus 10 microg conjugated synthetic PRP. Adverse events were actively recorded after vaccine administration. Total anti-HBs and IgG anti-PRP antibody titers were evaluated using commercial ELISA kits at baseline and 30 days post-vaccination. The combined vaccine candidate was safe and well tolerated. The most common adverse reactions were local pain, febricula, fever and local erythema. These reactions were all mild in intensity and resolved without medical treatment. Adverse events were mostly reported during the first 6-72 hours post-vaccination. There were no serious adverse events during the study. No severe or unexpected events were either recorded during the trial. The combined vaccine elicited an anti-HBs and anti-PRP booster response in 100% of subjects at day 30 of the immunization schedule. Anti-HBs and anti-PRP antibody levels had at least a two-fold increase compared to baseline sera. Even more, anti-HBs antibody titer showed a four-fold increase in 100% of volunteers in the study group. The results indicate that the combined HB-Hib vaccine produces increased antibody levels in healthy adults who have previously been exposed to these two antigens. To our knowledge, this is the first demonstration of safety and immunogenicity for a combined vaccine comprising recombinant HBV and synthetic Hib antigens. The present results support phase I-II clinical trial in the target population, two months old healthy infants.

Design and Objectives of the South American Youth/Child Cardiovascular and Environmental (SAYCARE) Study.

OBJECTIVE: The purpose of this paper is to introduce the overarching study design of the South American Youth/Child Cardiovascular and Environmental (SAYCARE) study, which is an observational multicenter feasibility study held in seven South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Montevideo (Uruguay), Santiago (Chile), and São Paulo and Teresina (Brazil). Children and adolescents (3-17 years of age) were studied. METHODS: The data management systems, quality assurance monitoring activities, standardized operating procedure manuals, and training and study management are addressed in this paper. Various quality controls to ensure the collection of valid and reliable data are also discussed. RESULTS AND CONCLUSIONS: Data were obtained from 237 preschoolers and schoolchildren and 258 adolescents during the validation phase measurements. The results of the SAYCARE study are expected to provide higher accuracy in the assessment of cardiovascular disease risk factors, including eating behaviors, body composition, physical activity, sedentary behaviors, lipid profiles and cardiovascular health biomarkers, oral health, social conditions, environmental factors and home environment, and their determinants in children and adolescents from ages 3 to 17 in seven South American cities.

Reliability and Validity of a Questionnaire for Physical Activity Assessment in South American Children and Adolescents: The SAYCARE Study.

OBJECTIVE: The objective of this article is to test the reliability and validity of the new and innovative physical activity (PA) questionnaire. METHODS: Subsamples from the South American Youth/Child Cardiovascular and Environment Study (SAYCARE) study were included to examine its reliability (children: n = 161; adolescents: n = 177) and validity (children: n = 82; adolescents: n = 60). The questionnaire consists of three dimensions of PA (leisure, active commuting, and school) performed during the last week. To assess its validity, the subjects wore accelerometers for at least 3 days and 8 h/d (at least one weekend day). The reliability was analyzed by correlation coefficients. In addition, Bland-Altman analysis and a multilevel regression were applied to estimate the measurement bias, limits of agreement, and influence of contextual variables. RESULTS: In children, the questionnaire showed consistent reliability (ρ = 0.56) and moderate validity (ρ = 0.46), and the contextual variable variance explained 43.0% with -22.9 min/d bias. In adolescents, the reliability was higher (ρ = 0.76) and the validity was almost excellent (ρ = 0.88), with 66.7% of the variance explained by city level with 16.0 min/d PA bias. CONCLUSIONS: The SAYCARE PA questionnaire shows acceptable (in children) to strong (in adolescents) reliability and strong validity in the measurement of PA in the pediatric population from low- to middle-income countries.

Continuous training and certification in neonatal resuscitation in remote areas using a multi-platform information and communication technology intervention, compared to standard training: A randomized cluster trial study protocol.

Background: About 10% of all newborns may have difficulty breathing and require support by trained personnel. In Peru, 90% of deliveries occur in health facilities. However, there is not a national neonatal resuscitation and certification program for the public health sector. In addition, the Andes and the Amazon regions concentrate large rural remote areas, which further limit the implementation of training programs and the accomplishment of continuous certification. Neonatal resuscitation training through the use of Information, Communication and Technology (ICT) tools, running on computers, tablets or mobile phones, may overcome such limitations. This strategy allows online and offline access to educational resources, paving the way to more frequent and efficient training, and certification processes. Objective: To evaluate the effects of a neonatal resuscitation training and certification program that uses a Multi-Platform ICT (MP-ICT) strategy on neonatal health care in remote areas. Methods: We propose to conduct the study through a cluster-randomized trial, where the study and analysis unit is the health care facility. Eligible facilities will include primary and secondary health care level facilities that are located in provinces with neonatal mortality rates higher than 15 per 1,000 live births. We will compare the proportion of newborns with a heart rate ≥100 beats per minute at two minutes after birth in health care facilities that receive MP-ICT training and certification implementation, with those that receive standard training and certification. Discussion: We expect that the intervention will be shown as more effective than the current standard of care. We are prepared to include it within a national neonatal resuscitation training and certification program to be implemented at national scale together with policymakers and other key stakeholders.  Trial registration: ClinicalTrials.gov Nº NCT03210194 Status of the study: This study is ongoing. Study protocol version 1.1 - March 31st, 2017.

Safety and effectiveness of propranolol in severely burned patients: systematic review and meta-analysis.

BACKGROUND: The objective of this systematic review was to determine the effectiveness and safety of propranolol compared to placebo or usual care for improving clinical relevant outcomes in severely burned patients (TBSA >20%). METHODS: Relevant articles from randomized controlled trials were identified by a literature search in MEDLINE, EMBASE, and CENTRAL. We included trials involving patients with a severe burn (>20% of total body surface area affected). Trials were eligible if they evaluated propranolol and compared to usual care or placebo. Two investigators independently assessed articles for inclusion and exclusion criteria and selected studies for the final analysis. We conducted a meta-analysis using a random-effects model. RESULTS: We included ten studies in our systematic review. These studies randomized a total of 1236 participants. There were no significant differences between propranolol and placebo with respect to mortality (RD -0.02 [95% CI -0.06 to 0.02]), sepsis (RD -0.03 [95% CI -0.09 to 0.04]), and the overall hospital stay (MD -0.37 [-4.52 to 3.78]). Propranolol-treated adults had a decrease in requirements of blood transfusions (MD -185.64 [95% CI -331.06 to -40.43]) and a decreased heart rate (MD -26.85 [95% CI -39.95 to -13.75]). CONCLUSIONS: Our analysis indicates that there were no differences in mortality or sepsis in severely burned patients treated with propranolol compared with those who had usual care or placebo. However, the use of propranolol in these patients resulted in lower requirements of blood transfusion and lower values of heart rate. The evidence synthesized in this systematic review is limited to conclude that propranolol reduces the length of hospital stay among severely burned patients. Future trials should assess the impact of propranolol on clinically relevant outcomes such as mortality and adverse events.

Bioequivalence of two recombinant interferon alpha-2b liquid formulations in healthy male volunteers.

OBJECTIVE: Interferon (IFN) alpha-2b is a protein with antiviral, antiproliferative and immunoregulatory properties that is approved for several clinical indications. A new liquid, albumin-free, IFNalpha-2b formulation has recently been developed. This study aimed to evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of the new formulation with a reference one in healthy male volunteers. METHODS: A randomised, crossover, double-blind study with a 3-week washout period was performed in which Heberon Alfa R (formulation A) and Viraferon (formulation B) were compared. A single 20 x 10(6) IU IFNalpha-2b dose was administered subcutaneously to 14 apparently healthy male subjects. Serum IFN level was measured over 48 hours by enzyme immunoassay (EIA) and by antiviral activity titration. Clinical and laboratory variables were determined, as were pharmacodynamic and safety criteria. RESULTS: Groups were homogeneous with regard to all demographic and baseline variables. Pharmacokinetic comparison by EIA did not show differences between the formulations: area under the curve (AUC) 2572 versus 2561 ng x h/L, maximum plasma concentration (Cmax) 318 versus 354 ng/L, time to Cmax (tmax) 8.2 versus 8.5 h, elimination half-life (t(1/2)) 5.87 versus 6.08 h, terminal elimination rate (lambda) 0.122 versus 0.118 h(-1), and mean residence time (MRT) 10.9 versus 12.0 h for formulations A and B, respectively. The differences never reached 20%, which is the clinically significant threshold. The 90% confidence interval of the ratio between them was in all cases within the 0.8, 1.25 range. The two formulations were clinically equivalent with regard to serum IFN antiviral activity titration (0.8, 1.25 criterion) regarding their pharmacokinetic parameters. There were no significant differences with respect to the pharmacodynamic variables: serum beta2-microglobulin and temperature increase. Heart rate and blood pressure changes did not differ either. Both products provoked similar haematological count decreases and had similar safety profiles. The most frequent adverse reactions were fever, tachycardia, headache and arthralgias. CONCLUSION: The overall analysis strongly suggests the bioequivalence of these two products.

Crecimiento bacteriano en la úlcera del pie diabético previo al uso de Heberprot-P / Bacterial growth in diabetic foot ulcer prior to Heberprot-P

OBJETIVO: determinar el comportamiento del crecimiento microbiológico en las úlceras de pie diabético, previo al uso del Heberprot-P. MÉTODOS: estudio descriptivo mediante la revisión de las historias clínicas de 52 pacientes, incluidos en los ensayos clínicos fase I y II del Heberprot-P en la úlcera de pie diabético. Se tomaron 63 muestras y se consideró el estudio microbiológico realizado en cualquier momento de su evolución, en el período de estudio. RESULTADOS: cuatro muestras resultaron negativas y 29 positivas a Staphylococcus aureus meticillin resistente, que fue el germen más frecuentemente cultivado, por lo que un tercio de los pacientes requirió tratamiento antimicrobiano. CONCLUSIONES: se recomienda realizar estudio microbiológico a todos los pacientes con úlcera de pie diabético, previo al uso de Heberprot-P aun cuando no existan evidencias clínicas de infección local.

OBJECTIVE: to determine the microbiological growth behavior in diabetic foot ulcers, pre Heberprot-P. METHODS: descriptive study was conducted by reviewing the medical records of 52 patients enrolled in Heberprot-P clinical trials phase I and II of diabetic foot ulcer. 63 samples were taken and microbiological study was considered at any point in its evolution in the study period. RESULTS: four samples were negative and 29 positive to Staphylococcus aureus meticillin resistant, which was the most frequently cultivated germ, so that one third of the patients required antibiotic treatment. CONCLUSIONS: microbiological study is recommended to all patients with diabetic foot ulcer, prior to the use of Heberprot-P even when there is no clinical evidence of local infection.

Resultados clínicos en pacientes con anastomosis intestinal primaria en cirugía de control de daños / Clinical results in patients with primary intestinal anastomosis in the damage control operative technique

Objetivo: Describir la experiencia en la aplicación de la técnica de control de daños en pacientes exanguinados con trauma abdominal severo. Evaluar en la cirugía por etapas del control de daños la utilización de la ligadura transitoria del intestino delgado y del colon con hiladilla, y la anastomosis primaria diferida como una técnica viable. Material y métodos: Entre 1999-2004 se estudiaron los pacientes consecutivos que fueron sometidos a la técnica de control de daños. Se analizaron parámetros de morbi-mortalidad, estancia en UCI y complicaciones...

Pancreatitis necrotizante infectada: resultados en una cohorte de baja mortalidad / Infected necrotizing pancreatitis: results in a low mortality cohort

Objetivo: Analizar los factores pronósticos asociados con mortalidad en pacientes con pancreatitis aguda severa. Métodos: Cohorte retrospectiva, pacientes consecutivos entre 1995-2004 con datos demográficos, clínicos y quirúrgicos, el diagnóstico de pancreatitis aguda severa definido como APACHE II > 8 o Ranson > 3. Resultados: Se incluyeron 64 pacientes. El origen más frecuente fue colelitiasis (51,6 porciento). La mediana del APACHE II=13. El promedio de estancia en la UCI fue de 16 más/menos 14,8 días (rango 1 – 63), la estancia hospitalaria total fue de 28,1 más/menos 19,8 días (1 - 84). El 82,8 porciento de los pacientes fueron operados, el promedio de re-laparotomías fue de 4,2 más/menos 4,4 (1-18). El 81,3 porciento desarrollaron necrosis: infectada o absceso=84,9 porciento y estéril=26,4 porciento. El 81,3 porciento de los pacientes se manejaron con antibióticos durante catorce días. El 60,9 porciento de los pacientes presentaron cultivos positivos en abdomen, los gérmenes más frecuentes fueron Enterococcus fecalis y Estafilococcus aureus...

Mortalidad por intoxicaciones agudas producidas con medicamentos. Cuba, 1995-1996 / Mortality caused by acute drug poisoning

Se realizó un estudio descriptivo para determinar la incidencia de intoxicaciones agudas fatales medicamentosas en 1995 y 1996, y los principales factores de riesgo en la población cubana. Ocurrieron 314 defunciones para una tasa de 1,4 por 100 000 habitantes. En edades pediátricas el riesgo superior se encuentra en los menores de 1 a y en los adultos el riesgo aumenta al avanzar la edad, con una mayor afectación del sexo femenino. Las edades de mayor riesgo son a partir de 55 a en las mujeres y en los hombres después de 75 a. Los años de vida potencialmente perdidos fueron 7 430, con predominio de las mujeres (74 porciento). En los adultos predominaron las circunstancias voluntarias, en especial los suicidios con ingestión de psicofármacos; el diazepam y el fenobarbital se encuentran entre los más elegidos. En segundo término aparecen las reacciones adversas, producidas fundamentalmente por antibióticos, con predominio de las penicilinas. Por último, las circunstancias accidentales originadas por cardiotónicos. En los niños no existió diferencia estadística significativa en las diferentes circunstancias

Bioequivalencia. Introducción a la correlación in vivo-in vitro: parte I / Bioequivalence. In vivo - in vitro correlation introducction: part I

El control de calidad sugerido por la farmacopea, para formas de dosificación oral, no asegura en muchos casos la bioequivalencia de todos los lotes que salen al mercado, por lo que se discutieron las causas que provocan esta deficiencia, entre las que se encuentran: la selección inadecuada de las especificaciones y condiciones de disolución y subestimar la influencia de las variables de manufactura críticas en el comportamiento de las formulaciones. Además, se estimuló el establecimiento de las correlaciones in vivo-in vitro, como la solución más aceptada internacionalmente para garantizar la calidad lote a lote. Se expusieron también las definiciones de correlación in vivo-in vitro y niveles de correlación propuestos. En las conclusiones se enfatizó la importancia que tiene el establecimiento, ajuste y control de las variables críticas y la obtención de una correlación in vivo-in vitro para determinar las especificaciones de disolución in vitro adecuadas