Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care unit (NICU) are limited to pacifier use or bottle-feeding exercises. Skin contact has been shown to be beneficial to start and maintain lactation and provide preterm infants with the opportunity to suck on the mother’s breast, which may promote further development of the preterm infant’s suckling patterns. The objective of this study is to compare and evaluate the effects of skin contact combined with breastfeeding (suck on the mother’s empty breast) as compared to the routine pacifier suckling training model in achieving full oral feeding for infants whose gestational age are ≤ 30 weeks. This is a single-center, randomized controlled clinical trial conducted in the NICU and designed according to the SPIRIT Statement. The subjects included in the study are premature infants born between April 2020 and July 2021 with a gestational age of ≤30 weeks, birth weight of <1500 g, admission age of <72 h, and absence of congenital malformations. Those with oxygenation indices of >40 and those born to mothers with poor verbal communication skills will be excluded. A sample of 148 infants is needed. The infants will be randomized to the intervention (skin contact combined with mother’s breastfeeding model) or control group (routine pacifier sucking training model). The primary outcome is the time required to achieve full oral feeding. The secondary outcomes are the breastfeeding abilities of preterm infants as assessed by the Preterm Infant Breastfeeding Behavior Scale (PIBBS), breastfeeding rates at 3 and 6 months corrected gestational age, complication rates, duration of oxygen requirement, days of hospital stay, and satisfaction of parents. This paper describes the first single-center, open-label, randomized clinical trial on this topic and will provide crucial information to support the implementation of skin contact combined with the breastfeeding model in the NICU setting. ClinicalTrials.gov NCT 04283682. Registered on 8 February 2020.

中文翻译：

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早期皮肤接触结合母亲母乳喂养缩短早产儿≤孕30周实现完全经口喂养的过程：随机对照试验的研究方案


大多数住院早产儿在从管饲过渡到完全经口喂养时遇到困难。促进新生儿重症监护病房 (NICU) 早产儿完全经口喂养的干预措施仅限于使用奶嘴或奶瓶喂养练习。皮肤接触已被证明有利于开始和维持哺乳，并为早产儿提供吸吮母亲乳房的机会，这可能促进早产儿吸吮模式的进一步发展。本研究的目的是比较和评估皮肤接触联合母乳喂养（吸吮母亲空乳房）与常规奶嘴哺乳训练模式相比，对胎龄≤30周婴儿实现完全经口喂养的效果。这是一项在 NICU 中进行的单中心、随机对照临床试验，并根据 SPIRIT 声明设计。研究纳入的受试者为2020年4月至2021年7月出生的早产儿，胎龄≤30周，出生体重<1500 g，入院年龄<72 h，无先天畸形。氧合指数为>40的孩子以及语言沟通能力较差的母亲所生的孩子将被排除在外。需要 148 名婴儿的样本。婴儿将被随机分为干预组（皮肤接触结合母亲母乳喂养模型）或对照组（常规奶嘴吸吮训练模型）。主要结果是实现完全经口喂养所需的时间。 次要结局是通过早产儿母乳喂养行为量表 (PIBBS) 评估的早产儿母乳喂养能力、3 个月和 6 个月校正胎龄时的母乳喂养率、并发症发生率、需氧量持续时间、住院天数以及对母乳喂养的满意度。父母。本文描述了关于该主题的第一个单中心、开放标签、随机临床试验，并将为支持在 NICU 环境中实施皮肤接触结合母乳喂养模式提供重要信息。 ClinicalTrials.gov NCT 04283682。2020 年 2 月 8 日注册。