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

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 pr...

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Autores principales: Wang, Xueyin, Zhang, Xiaosong, Sobel, Howard Lawrence, Li, Zhao, Juan, Juan, Yang, Huixia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389737/
https://www.ncbi.nlm.nih.gov/pubmed/35986372
http://dx.doi.org/10.1186/s13063-022-06615-z
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author Wang, Xueyin
Zhang, Xiaosong
Sobel, Howard Lawrence
Li, Zhao
Juan, Juan
Yang, Huixia
author_facet Wang, Xueyin
Zhang, Xiaosong
Sobel, Howard Lawrence
Li, Zhao
Juan, Juan
Yang, Huixia
author_sort Wang, Xueyin
collection PubMed
description 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06615-z.
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spelling pubmed-93897372022-08-20 Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial Wang, Xueyin Zhang, Xiaosong Sobel, Howard Lawrence Li, Zhao Juan, Juan Yang, Huixia Trials Study Protocol 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06615-z. BioMed Central 2022-08-19 /pmc/articles/PMC9389737/ /pubmed/35986372 http://dx.doi.org/10.1186/s13063-022-06615-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Wang, Xueyin
Zhang, Xiaosong
Sobel, Howard Lawrence
Li, Zhao
Juan, Juan
Yang, Huixia
Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title_full Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title_fullStr Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title_full_unstemmed Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title_short Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
title_sort early essential newborn care for cesarean section newborns in china: study protocol for a multi-centered randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389737/
https://www.ncbi.nlm.nih.gov/pubmed/35986372
http://dx.doi.org/10.1186/s13063-022-06615-z
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