中国剖宫产新生儿早期基本保健：一项多中心随机对照试验的研究方案。

Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, Peking University First Hospital, No. 1 Xi'anmen Street, Beijing, 100034, China.

Maternal, Child Health and Quality and Safety, World Health Organization Regional Office for the Western Pacific, Manila, Philippines.

出版信息

Trials. 2022 Aug 19;23(1):696. doi: 10.1186/s13063-022-06615-z.

DOI:10.1186/s13063-022-06615-z

PMID:35986372

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9389737/

Abstract

BACKGROUND

Early essential newborn care (EENC) is a package of evidence-based and cost-effective interventions delivered around birth mainly including delayed cord clamping, immediate and sustained skin-to-skin contact, and early initiation of exclusive breastfeeding. EENC is proven effective in promoting breastfeeding and improving women's and newborns' health. However, there is little evidence on implementation of EENC on newborns born by cesarean section in China. Therefore, the objective of this study is to assess the effectiveness of EENC intervention on rates of exclusive breastfeeding and early initiation of breastfeeding for cesarean section newborns in China.

METHODS

This is a multi-centered, randomized controlled trial conducted in 4 tertiary hospitals in China. A total of 720 eligible women who will receive cesarean section are being randomized into four groups: control group (n=180), intervention group 1 (skin-to-skin contact for 30 min, n=180), intervention group 2 (skin-to-skin contact for 60 min, n=180), and intervention group 3 (skin-to-skin contact for 90 min, n=180). The control group will receive routine care, whereas the intervention groups will receive EENC with different duration of skin-to-skin contact. Demographic characteristics, clinical information, and breastfeeding outcomes will be collected. The primary outcome is rates of exclusive breastfeeding and early initiation of breastfeeding, and the secondary outcomes include maternal and neonatal morbidity and admissions.

DISCUSSION

This study will provide evidence of the impact of EENC on improvement of breastfeeding outcomes and maternal and neonatal health for cesarean section newborns in China, and evidence-based recommendation to inform optimal duration of skin-to-skin contact for cesarean deliveries. The results of this study have potential to inform national-level guidelines and policy-making for optimizing EENC implementation for cesarean section newborns.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100048997. Retrospectively registered on 19 July 2021.

摘要

背景

早期基本新生儿护理（EENC）是一套基于证据和具有成本效益的干预措施，主要在分娩时实施，包括延迟脐带结扎、立即和持续的皮肤接触以及尽早开始纯母乳喂养。EENC 已被证明可有效促进母乳喂养并改善母婴健康。然而，在中国，关于剖宫产新生儿实施 EENC 的证据很少。因此，本研究的目的是评估 EENC 干预对中国剖宫产新生儿纯母乳喂养率和母乳喂养启动率的效果。

方法

这是一项在中国 4 家三级医院进行的多中心随机对照试验。共有 720 名符合条件的将接受剖宫产的女性被随机分为 4 组：对照组（n=180）、干预组 1（皮肤接触 30 分钟，n=180）、干预组 2（皮肤接触 60 分钟，n=180）和干预组 3（皮肤接触 90 分钟，n=180）。对照组将接受常规护理，而干预组将接受不同持续时间的皮肤接触的 EENC。将收集人口统计学特征、临床信息和母乳喂养结果。主要结局是纯母乳喂养率和母乳喂养启动率，次要结局包括母婴发病率和住院率。