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. 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. 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). 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. ClinicalTrials.gov NCT02687685 .

中文翻译：

---

出生时皮肤接触的开始时间（立即与早期相比）对足月新生儿母乳喂养持续时间的影响的随机临床试验

与出生时分离相比，皮肤对皮肤接触 (SSC) 对母乳喂养有积极影响。然而，出生时的分离很常见，会对母乳喂养产生负面影响。目的是确定立即 SSC 与早期 SSC 相比对纯母乳喂养持续时间的影响。2018 年 11 月至 2020 年 1 月期间，在昆迪纳马卡（哥伦比亚）的两家医院进行了一项随机多中心平行临床试验。包括出生时低风险足月新生儿。新生儿被分配到立即（出生后第一分钟）或早发（刚好从出生 60 分钟开始）皮肤接触。每月随访至 6 个月大。主要结果是 6 个月时纯母乳喂养婴儿的百分比（以母乳为唯一食物来源的时间，以月为单位）。次要结果是 3 个月时纯母乳喂养的婴儿百分比、纯母乳喂养的月份持续时间、新生儿的母乳喂养能力、出生和出生第一周之间的体重变化百分比以及第一周新生儿病房的住院情况。进行双变量分析以确定与 6 个月时纯母乳喂养相关的变量。进行生存分析以评估 SSC 发作对纯母乳喂养持续时间的影响。总共包括 297 名新生儿：即刻 SSC 组 49.8% (n = 148)，早期 SSC 组 50.2% (n = 149)。两组纯母乳喂养的平均持续时间为 5 个月。6 个月时纯母乳喂养的百分比在各组之间没有差异（相对风险 [RR] 1.06，95% CI 0.72, 1.58) 或在纯母乳喂养期间（风险比 [HR] 0.98, 95% CI 0.74, 1.28）。两组 SSC 干预措施的婴儿百分比和前 6 个月内纯母乳喂养的持续时间相同。鉴于目前实施的障碍，本研究的结果可能会对出生时 SSC 的使用产生积极影响，并使干预标准化并改善母乳喂养指标。ClinicalTrials.gov NCT02687685。这项研究的结果可以对出生时 SSC 的使用产生积极影响，并使干预标准化并改善母乳喂养指标。ClinicalTrials.gov NCT02687685。这项研究的结果可以对出生时 SSC 的使用产生积极影响，并使干预标准化并改善母乳喂养指标。ClinicalTrials.gov NCT02687685。