ABSTRACT
BACKGROUND: Skin-to-skin contact (SSC) compared to separation at birth has a positive effect on breastfeeding. However, separation at birth is common with negative impact on breastfeeding. The aim was to determine the effect of immediate SSC compared to early SSC on the duration of exclusive breastfeeding. METHODS: A randomized multicentre parallel clinical trial was conducted in two hospitals in Cundinamarca (Colombia) between November 2018 and January 2020. Low-risk full term newborns at birth were included. Neonates were assigned to immediate (in the first minute after birth) or early onset (start exactly at 60 min of life) skin to skin contact. Monthly follow-up was performed until 6 months of age. The primary outcome was the percentage of exclusively breastfed infants at 6 months (time in months with human milk as the only source of food). Secondary outcomes were the percentage of infants with exclusive breastfeeding at 3 months, duration in months of exclusive breastfeeding, neonate's breastfeeding ability, percentage of weight change between birth and the first week of life and hospitalization in the neonatal unit in the first week. A bivariate analysis was performed to determine the variables associated with exclusive breastfeeding at 6 months. A survival analysis was performed to evaluate the effect of the onset of SSC on exclusive breastfeeding duration. RESULTS: A total of 297 newborns were included: 49.8% (n = 148) in the immediate SSC group, and 50.2% (n = 149) in the early SSC group. The mean duration of exclusive breastfeeding in both groups was 5 months. There were no differences between the groups in the percentage of exclusive breastfeeding at 6 months (relative risk [RR] 1.06, 95% CI 0.72, 1.58) or in the duration of exclusive breastfeeding (hazard ratio [HR] 0.98, 95% CI 0.74, 1.28). CONCLUSIONS: The percentage of infants and the duration of exclusive breastfeeding in the first 6 months of age were the same between the two groups of SSC interventions. Given the current barriers to its implementation, the results of this study could positively impact the use of SSC at birth and standardize the intervention and improve breastfeeding indicators. TRIAL REGISTRATION: ClinicalTrials.gov NCT02687685 .
Subject(s)
Breast Feeding , Kangaroo-Mother Care Method , Child , Colombia , Female , Humans , Infant , Infant, Newborn , Milk, Human , Parturition , PregnancyABSTRACT
BACKGROUND: Human lactancy is a simple and cost-effective strategy that influences infant and maternal mortality rates. Skin-to-skin contact (SSC) is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and to decrease hospitalization during the first week of life. This study aims to determine the effect of SSC initiation at birth (immediate versus early) in healthy, full-term newborns treated at the Universidad de La Sabana Clinic on the duration of exclusive human lactation. METHODS/DESIGN: A randomized, blind clinical trial will be performed with full-term healthy newborns born at the Universidad de La Sabana Clinic. The blind trial participants will be those persons measuring the results and analyzing the data. The sample size will be calculated for a type I error of 5 %, a two-tailed type II error of 20 %, and an estimated percentage loss of 30 %; 150 infants will be included in each group. Randomization will be performed using permuted, size-6 blocks. Descriptive analysis will be conducted using central tendency and dispersion measurements. A bivariate analysis will be performed to determine which variables are associated with exclusive lactancy at 6 months. For continuous variables, Student's t test will be used for independent samples, and the Wilcoxon rank sum test will be used if the assumptions of normality for the t tests are not fulfilled. The assumption of normality will be evaluated using the Shapiro-Wilk and Kolmogorov-Smirnov tests. Categorical variables in contingency tables will be constructed to assess the independence between variables using the chi-square test, or Fisher's exact test when the assumption of the number of cases is not met by the values in the contingency tables multiplied by two. This will be calculated as a measurement of the effect of relative risk (RR) with confidence intervals; the adjusted measurements will be calculated using a multivariate regression Poisson model. Variables with significant results will be used in the bivariate analysis, and those with biological plausibility will be used for the adjustment. The analysis will be carried out for a two-tailed type I error level of 5 %. The Stata 11 program will be used for data analysis. An interim analysis will be performed upon the submission of half the expected events (106), setting limits for the early termination of the trial according to the method proposed by Pampallona and Tsiatis (1994). INTERVENTION: There will be two SSC randomization groups: early versus immediate. After completing the neonatal adaptation process and based on the group assignment, the mother will be left with her newborn child in hospital accommodation. Prior to discharge, the Infant Breast-Feeding Assessment Tool (IBFAT) will be applied. Monitoring will initially be performed with a face-to-face assessment between 3 and 10 days of life, followed by monthly telephone calls for 6 months to verify lactation status. DISCUSSION: SSC at birth has shown benefits in the short and long term for both the mother and the full-term newborn. Although the meta-analysis that have been done have shown the benefits of this technique, multiple differences in the SSC interventions have been identified because criteria such as the initiation or duration of SSC (dose) have not been unified. Colombia has a malnutrition risk of 11,4 % in the total population for the period 2012-2014, so it is necessary to promote strategies that generate a positive impact on the duration of human lactation, providing support from the clinical setting of humanized delivery which is included in the IAMI strategy (Instituciones Amigas de la Mujer y la Infancia - Friends of Women and Children Institution). Therefore, we propose that the initiation time of SSC in full-term new-borns is related to the duration of exclusive human lactation. TRIAL REGISTRATION: Registered ClinicalTrials.gov Identifier: NCT 02687685 . Registered on 2 February 2016. This study is not yet open for participant recruitment.
Subject(s)
Breast Feeding , Kangaroo-Mother Care Method , Mother-Child Relations , Mothers/psychology , Object Attachment , Skin Physiological Phenomena , Touch , Chi-Square Distribution , Clinical Protocols , Colombia , Female , Hospitals, University , Humans , Infant , Infant, Newborn , Multivariate Analysis , Odds Ratio , Research Design , Time FactorsABSTRACT
INTRODUCCIÓN: La infección respiratoria aguda es un problema de salud pública en menores de 5 años; la detección e identificación tempranas de sus signos disminuye la mortalidad en este grupo de edad y es una meta de la formación médica. OBJETIVO: Comparar en estudiantes de medicina el método educativo tradicional y el escenario simulado para el reconocimiento de signos de enfermedad respiratoria aguda en niños de 2 meses a 5 años. SUJETOS Y MÉTODOS: Se realizó un ensayo clínico para estudiantes de medicina, aleatorizados en dos grupos: A (clase teórica y ayudas audiovisuales) y B (escenario simulado). El desenlace primario fue el desempeño en la evaluación global. Se realizó prueba de Mann-Withney Wilcoxon para comparación entre grupos y Mann-Withney Wilcoxon pareada para análisis intragrupo (antes y después de la intervención). RESULTADOS: Mediante prueba de Mann-Withney Wilcoxon pareada intragrupo pre y postintervención, el grupo A mostró mejor un desarrollo de competencias en el desenlace primario (p = 0,02) y en la evaluación global del escenario simulado (p = 0,04). El grupo B logró cambios significativos en el desenlace primario (p = 0,00), la anamnesis (p = 0,00) y la evaluación global del escenario simulado (p = 0,00). En la evaluación postintervención no se encontraron diferencias significativas en el desenlace primario ni secundario. CONCLUSIONES. La comparación postintervención entre los grupos A y B no mostró diferencias significativas en ninguna de las variables estudiadas entre ambos grupos
INTRODUCTION: The acute respiratory infection is a public health problem in children under 5 years of age. The early detection and identification of its signs reduces the mortality rates in these age groups and is an objective in medical education. AIM. To compare the traditional teaching method with the simulated-scenario teaching method in the acquisition of skills necessary to recognize respiratory distress in children between 2 months and 5 years of age by medical students. SUBJECTS AND METHODS: A clinical trial was done for medical students and they were divided into two randomized groups: group A which used the traditional teaching method and group B, which used the simulated-scenario method. The primary outcomes were seen in the global evaluation performances. A Mann-Withney Wilcoxon test was used for the comparison among groups and a paired Mann-Withney Wilcoxon test was used for the intra-group analysis (before and after the intervention). RESULTS: When using the paired Mann-Withney Wilcoxon intragroup test pre and post intervention, group A showed a better skill development in the primary outcome (p = 0.02) and the global evaluation in simulated scenario (p = 0.04). On the other hand, group B reached significant changes on the primary outcomes (p = 0.00), anamnesis (p = 0.00) and global evaluation with the simulated-scenario method (p = 0.00). It was observed that in the post-intervention evaluation there werent any significant differences between the primary and secondary outcomes. CONCLUSIONS: The post-intervention comparison between groups A and B didnt show significant differences in the studied variables between both groups
Subject(s)
Humans , /methods , Education, Medical/methods , Severe Acute Respiratory Syndrome/diagnosis , Respiration Disorders/diagnosis , Respiratory Insufficiency/diagnosis , Respiratory Tract Diseases/diagnosis , Computer Simulation , Models, Theoretical , Symptom Assessment/methods , Diagnosis, DifferentialABSTRACT
BACKGROUND: Although hematology and oncology research is a highly relevant and evolving field, research contributions by Latin American countries, apart from Brazil, remain unclear. METHODS: The authors performed a bibliometric analysis through a methodical search of the Latin American abstracts presented at 4 main hematology and oncology annual scientific meetings from 2000 to 2010. Latin American regional and national productivity was described through distribution and trend analyses; the subsequent percentage of full-text publications was also determined. RESULTS: In total, 2871 abstracts were identified, of which 1972 abstracts (68.7%) were determined to be original Latin American research and were included in the analysis. Brazil produced by far the most abstracts, with 51.1% of the total, followed by Argentina, Mexico, Peru, Chile, and Uruguay. Together, these 6 countries accounted for 95.2% of the abstracts. Latin America had a positive trend, registering an average increase of 21.5 abstracts per year (P < .001). Significant positive growth trends were observed for Brazil, Mexico, Peru, and Uruguay. Argentina and Uruguay were the most productive countries when considering the rate of abstract presentation per population. The full-text publication rate was 17.9%, and the median time to publication after presentation was 1 year. Brazil prevailed as the leading publishing country (60%), followed by Mexico, Argentina, Peru, Chile, and Cuba, all of which together published 96% of the full-text articles. CONCLUSIONS: Hematology and oncology research is increasing in Latin America, but this contribution remains limited to a few countries. There is also a low rate of full-text articles derived from annual scientific meetings. More extensive research is recommended.
