Agudelo Sergio, Gamboa Oscar, Rodríguez Fabio, Cala Sandra, Gualdrón Nathalie, Obando Evelyn, Padrón María Lucía
Universidad de La Sabana, Clínica Universidad de La Sabana, Chía, Cundinamarca, Colombia.
Assistant professor Universidad de La Sabana, Neonatal Care Unit Coordinator of Clínica Universidad de La Sabana, Campus Puente del Común, Km. 7 Autopista al Norte de Bogotá, 53753, Chía, Cundinamarca, Colombia.
Trials. 2016 Oct 26;17(1):521. doi: 10.1186/s13063-016-1587-7.
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).
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.
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.
Registered ClinicalTrials.gov Identifier: NCT 02687685 . Registered on 2 February 2016. This study is not yet open for participant recruitment.
母乳喂养是一种简单且具成本效益的策略，会影响婴儿和产妇死亡率。皮肤接触（SSC）是产后即刻实施的一种策略，已证实有助于启动和持续母乳喂养，并减少出生后第一周的住院时间。本研究旨在确定在萨巴纳大学诊所接受治疗的健康足月新生儿中，出生时即刻（与早期相比）开始皮肤接触对纯母乳喂养持续时间的影响。
方法/设计：将对在萨巴纳大学诊所出生的足月健康新生儿进行一项随机、盲法临床试验。盲法试验参与者将是测量结果和分析数据的人员。将计算样本量，设定I型错误为5%，双尾II型错误为20%，估计失访率为30%；每组将纳入150名婴儿。将使用排列的6大小的区组进行随机分组。将使用集中趋势和离散度测量进行描述性分析。将进行双变量分析以确定哪些变量与6个月时的纯母乳喂养相关。对于连续变量，将使用独立样本的Student's t检验，如果t检验的正态性假设不成立，则使用Wilcoxon秩和检验。将使用Shapiro-Wilk和Kolmogorov-Smirnov检验评估正态性假设。将构建列联表中的分类变量，使用卡方检验评估变量之间的独立性，当列联表中的值乘以2未满足病例数假设时，使用Fisher精确检验。这将作为相对风险（RR）及其置信区间的效应测量进行计算；将使用多元回归泊松模型计算调整后的测量值。具有显著结果的变量将用于双变量分析，具有生物学合理性的变量将用于调整。将针对双尾I型错误水平为5%进行分析。将使用Stata 11程序进行数据分析。将在提交一半预期事件（106个）时进行中期分析，根据Pampallona和Tsiatis（1994）提出的方法设定试验提前终止的界限。
将有两个皮肤接触随机分组：早期与即刻。在完成新生儿适应过程并根据分组情况，母亲将与她的新生儿留在医院病房。出院前，将应用婴儿母乳喂养评估工具（IBFAT）。最初将在出生后3至10天进行面对面评估进行监测，随后在6个月内每月进行电话随访以核实哺乳状况。
出生时的皮肤接触已显示对母亲和足月新生儿在短期和长期均有益处。尽管已进行的荟萃分析显示了该技术的益处，但已确定皮肤接触干预存在多种差异，因为诸如皮肤接触的开始或持续时间（剂量）等标准尚未统一。在2012 - 2014年期间，哥伦比亚总人口的营养不良风险为11.4%，因此有必要推广对母乳喂养持续时间产生积极影响的策略，在IAMI战略（妇女和儿童友好机构）所包含的人性化分娩临床环境中提供支持。因此，我们提出足月新生儿皮肤接触的开始时间与纯母乳喂养的持续时间相关。
在ClinicalTrials.gov注册的标识符：NCT 02687685。于2016年2月2日注册。本研究尚未开放招募参与者。
