Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding prevalence, infant growth velocity and postpartum weight loss in overweight or obese women: protocol for a randomized controlled trial

Background: Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced. Obesity rates have been increasing worldwide. Overweight or obese women have lower rates of breastfeeding and face mechanical, psychological and biological difficulties. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women; but there is a lack of evidence on its effectiveness in overweight women. Our purpose is to evaluate a new approach to exclusive breastfeeding counselling based on Carl Rogers' Centred-Client Theory in overweight women, and to examine effects on breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss. Methods: A two-arm simple randomized controlled trial will be conducted in overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia. The intervention is exclusive breastfeeding counselling based on Rogers' theory but adapted for overweight women; it will be performed during the last month of pregnancy, 24 h after delivery and during early infancy (1 and 3 months postpartum). The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels. Intention to treat analysis will be performed to estimate the effect of the new counselling approach compared to standard management on the prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss. Discussion: We hypothesize that the intervention will result in an increase in the initiation and maintenance of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery. It is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women. Trial registration: (UTN) U1111-1228-9913 February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered

Associations between maternal BMI, breastfeeding practices and infant anthropometric status in Colombia; secondary analysis of ENSIN 2010

BACKGROUND Maternal malnutrition and infant feeding mode impact short and long term infant and child morbidity and mortality. The period of lactation may provide an opportunity to modulate the risk of disease later in life. Our aim was to estimate the effect of maternal body mass index (BMI) and infant feeding mode, particularly breastfeeding practices, on the anthropometric status of children under 2 years in Colombia. METHODS A secondary analysis was performed using the data from ENSIN 2010. Term infants under 2y, singleton, with a mother older than 18y, were included in the analysis. Outcomes were wasting (WLZ  +2SD) and stunting (LAZ < -2SD). Predictors were infant feeding (exclusive and predominant BF constructed from 24-h recall, age at introduction of liquids, semisolids and solids) and maternal BMI. Socioeconomic variables, maternal education and age, conditions during pregnancy and birth weight were analyzed as covariates. RESULTS Mothers of overweight infants had higher BMI (Mean dif = 1.47 kg/m2; 95% CI = 2.1, 0.8) than those with normal weight infants. Stunting and wasting were not predicted by maternal anthropometry or infant feeding mode. Fewer maternal years of education were associated with wasting (OR = 0.90; 95% CI = 0.86, 0.97; p = 0.003) and stunting (OR = 0.92; 95% CI = 0.89, 0.94; p < 0.0001), while more maternal years of education were associated with overweight (OR = 1.06; 95% CI = 1.02, 1.01; p = 0.001); higher birth weight was associated with overweight (OR = 1.001; 95% CI = 1.00, 1.001; p < 0.0001) and lower birth was associated with stunting (OR = 0.99; 95% CI = 0.89; p < 0.0001) in the final regression model. CONCLUSIONS Maternal BMI is a modifiable target for public health policy to promote healthy infant growth. Infant nutritional status is affected by direct and indirect factors that need to be addressed in further studies

Primer Consenso Venezolano de Enfermedad por Reflujo Gastroesofágico Venezuelan consensus on gastroesophageal reflux diseases

El Consenso Venezolano de Enfermedad por Reflujo Gastroes&oacute;f&aacute;gico (ERGE) se realiz&oacute; con el objeto de proveer gu&iacute;as para mejorar la identificaci&oacute;n, el diagn&oacute;stico y el tratamiento de este trastorno en el pa&iacute;s. Los coordinadores establecieron las l&iacute;neas de consenso, basado en una revisi&oacute;n sistem&aacute;tica de la literatura m&eacute;dica de los &uacute;ltimos 15 a&ntilde;os a partir de1995. Participaron 55 miembros con el aval de sus respectivas c&aacute;tedras y sociedades locales de gastroenterolog&iacute;a. &Eacute;stos revisaron y presentaron los temas con sus niveles de evidencia y grados de recomendaci&oacute;n para discutirlos y votarlos en una reuni&oacute;n plenaria. Tras un informe final de los miembros, los coordinadores prepararon las declaraciones finales. El consenso concluy&oacute; que la enfermedad por reflujo gastroesof&aacute;gico tiene una prevalencia estimada del 11,54% en Venezuela, a predominio del sexo femenino (Grado B). El diagn&oacute;stico es fundamentalmente cl&iacute;nico, basado en la presencia de s&iacute;ntomas t&iacute;picos y/o at&iacute;picos, e incluso s&iacute;ntomas de alarma que sugieren alguna complicaci&oacute;n (Grado B). La endoscopia es importante en la investigaci&oacute;n de la presencia de esofagitis de reflujo y laringitis de reflujo (Grado B). Las otras pruebas diagn&oacute;sticas como lo son la pHmetr&iacute;a esof&aacute;gica de 24 horas con o sin impedancia intraluminal multicanal son importantes en los pacientes que no tienen esofagitis, tienen s&iacute;ntomas at&iacute;picos o cuando hay falla en la respuesta al tratamiento m&eacute;dico (Grado B). La radiolog&iacute;a, manometr&iacute;a esof&aacute;gica y el ultrasonido endosc&oacute;pico no est&aacute;n indicados en el diagn&oacute;stico de la ERGE (Grado B). El objetivo del tratamientoes reducir la exposici&oacute;n &aacute;cida en el es&oacute;fago y con esto: aliviar los s&iacute;ntomas, cicatrizar las lesiones en la mucosa esof&aacute;gica, prevenir la recurrencia y las complicaciones. Los inhibidores de bomba de protones deber&iacute;an ser la primera opci&oacute;n en el tratamiento en el s&iacute;ndrome de ERGE y en la esofagitis por reflujo tanto en la fase aguda como durante el mantenimiento, a dosis est&aacute;ndar o a la mitad de la dosis (Grado A). Los procin&eacute;ticos actualmente son f&aacute;rmacos con un papel limitado en la ERGE. Estimulan la motilidad esofago - g&aacute;strica, aumentan el tono del esf&iacute;nter esof&aacute;gico inferior y aceleran el vaciamiento g&aacute;strico (Grado B). El tratamiento quir&uacute;rgico est&aacute; indicado en pacientes seleccionados, en donde el abordaje por laparoscopia y las fundoplicaturas parciales tienen menos complicaciones (Grado B). El tratamiento endosc&oacute;pico es controversial y no es recomendado por este consenso hasta que surjan nuevas t&eacute;cnicas o se perfeccionen las existentes. (Grado B).The Venezuelan Gastroesophageal Reflux Disease (GERD) Consensus was carried out in order to provide guidelines to improve the identification, diagnosis and treatment of this illness in Venezuela. The coordinators established the consensus lines, based on a systematic revision of the medical literature of the last 15 years starting from 1995. 55 physicians participated with the support of their respective medical schools and local societies. They revised and presented the topics with their respective evidence levels and recommendation grades to discuss and vote them in a plenary meeting. After a final report of the members, the coordinators prepared the definitive declarations. The consensus concluded that GERD prevalence in Venezuela is 11,54%, higher in women than men (Grade B). The diagnosis is mainly clinical, based on the presence of typical and/or atypical symptoms and alarm symptoms that may suggest the presence of complications (Grade B). Endoscopy is important when reflux esophagitis and laryngitis are present (Grade B). Other diagnostic tests as ambulatory 24 hours pH monitoring with or without multichannel intraluminal impedance are important in patients without esophagitis, with atypical symptoms or when there is flaw in the answer to the medical treatment (Grade B). Radiology, esophageal manometry and endoscopic ultrasonography are not indicated in the diagnosis of GERD (Grade B). The objective of the treatment is to reduce the presence of acid in the esophagus and consequently: alleviate the symptoms and heal lesions in the esophagus mucosa to prevent recurrence and complications. Proton pump inhibitors should be the first option drug in the treatment of GERD syndrome and in esophagitis during the acute and the maintenance phase using standard or half dose (Grade A). So far, pokinetics are drugs with a limited use in GERD patients; they stimulate the esophagus/gastric motility, increase the tone of the lower esophagic sphincter and accelerate gastric emptying (Grade B). Surgical treatment is indicated in selected patients where laparoscopy and the partial fundoplication have less complications (Grade B). Endoscopic treatment is controversial and is not recommended by this consensus until new techniques arise or the existent ones are perfected. (Grade B)

Memorias de Hacienda y del Tesoro y de la Nueva Granada y Colombia, siglo XIX

En este libro digital el Banco de la República pone a disposición de los investigadores y bibliotecas del país la totalidad de las memorias de Hacienda y Tesoro colombianas que se publicaron en el siglo XIX. Es una herramienta bibliográfica que esperamos sea de enorme utilidad para los profesionales, estudiantes y amantes de la historia de Colombia. El célebre economista austriaco Joseph Schumpeter sostenía que las finanzas públicas son uno de los mejores puntos de partida para investigar una sociedad: allí se reflejan la riqueza, su distribución territorial y sectorial, la marcha de la actividad económica, las prioridades en el gasto y sus beneficiarios. Por su relevancia, y por cuanto los ciudadanos quieren saber en qué se gastan los impuestos que han pagado, los gobiernos democráticos han sido cuidadosos en la rendición de informes periódicos sobre los recaudos, los gastos, los excedentes o déficits en las finanzas gubernamentales y las formas de cubrir estos últimos. Para ello, con cierta regularidad se presentan informes a los órganos de control político o administrativo. Por esa razón, en el Banco de la República hemos considerado que un aporte bibliográfico de gran relevancia para el estudio de la historia económica nacional es poner a disposición de los investigadores y bibliotecas del país esta edición digital de las memorias de Hacienda y Tesoro del siglo XIX

Complete inventory of the yeast ABC proteins.

The complete sequence of the yeast genome predicts the existence of 29 proteins belonging to the ubiquitous ATP-binding cassette (ABC) superfamily. Using binary comparison, phylogenetic classification and detection of conserved amino acid residues, the yeast ABC proteins have been classified in a total of six clusters, including ten subclusters of distinct predicted topology and presumed distinct function. Study of the yeast ABC proteins provides insight into the physiological function and biochemical mechanisms of their human homologues, such as those involved in cystic fibrosis, adrenoleukodystrophy, Zellweger syndrome, multidrug resistance and the antiviral activity of interferons

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Background: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18–60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020–003998–22, and is ongoing. Findings: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. Interpretation: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. Funding: German Federal Ministry of Education and Research and CureVac