脐带动脉结扎时机对计划母乳喂养的低风险日本足月儿预防早期婴儿贫血的影响：一项随机对照试验。
Effects of timing of umbilical cord clamping on preventing early infancy anemia in low-risk Japanese term infants with planned breastfeeding: a randomized controlled trial.
作者信息
Shinohara Eriko, Kataoka Yaeko, Yaju Yukari
机构信息
Department of Nursing, School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.
Division of Women's Health and Midwifery, Graduate School of Nursing Science, St. Luke's International University, 10-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan.
出版信息
Matern Health Neonatol Perinatol. 2021 Jan 19;7(1):5. doi: 10.1186/s40748-021-00125-7.
BACKGROUND
Japanese infants have relatively higher risk of anemia and neonatal jaundice. This study aimed to assess the effects of delayed cord clamping (DCC) on the incidence of anemia during early infancy in low-risk Japanese term infants with planned exclusive breastfeeding for 4 months. This study also aimed to explore the effects of DCC on neonatal jaundice.
METHODS
We conducted an open-label, parallel-arm, multicenter randomized controlled trial of DCC (clamping the cord after more than a minute or pulsation stops) vs. early cord clamping (ECC; clamping the cord within 15 s) at one birth center and two clinics in Japan. Low-risk pregnant women planning to have a vaginal birth and to exclusively breastfeed and term singleton infants delivered in cephalic presentation were included in this study. The primary outcome was spectrophotometric estimation of hemoglobin at 4 months. Secondary outcomes were anemia incidence at 4 months, four outcomes related to neonatal jaundice, hematocrit levels, and related outcomes.
RESULTS
Overall, 150 pregnant women were recruited. Participants (N = 138) were randomly allocated to two groups (DCC n = 68, ECC n = 70). There were no significant differences between the two groups in spectrophotometric estimation of hemoglobin at 4 months: mean difference = 0.1 g/dL, 95% confidence interval - 0.14, 0.35, DCC 12.4 g/dL, ECC 12.3 g/dL. Only the hematocrit levels on days 3 to 5 were significantly higher in the DCC group than in the ECC group: DCC 57.0%, ECC 52.6%, mean difference = 4.4, 95% confidence interval 2.61, 6.20. There were no significant differences in other secondary outcomes, including outcomes related to neonatal jaundice.
CONCLUSION
Among low-risk Japanese term infants with planned exclusive breastfeeding, DCC showed no significant effects on spectrophotometric hemoglobin levels at 4 months compared with ECC. We observed significantly higher hematocrit levels on days 3 to 5 in infants who underwent DCC, while these levels were within the normal range. Jaundice outcomes remained similar to those of infants who underwent ECC. Although a larger sample size is required to assess the effects of cord clamping on neonatal jaundice, DCC may prevent anemia in newborn infants.
TRIAL REGISTRATION
UMIN-CTR; UMIN000022573, 06/01/2016 - retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023056.
背景
日本婴儿患贫血和新生儿黄疸的风险相对较高。本研究旨在评估延迟脐带结扎（DCC）对计划纯母乳喂养4个月的低风险日本足月儿早期婴儿期贫血发生率的影响。本研究还旨在探讨DCC对新生儿黄疸的影响。
方法
我们在日本的一个分娩中心和两家诊所进行了一项开放标签、平行组、多中心随机对照试验，比较DCC（在一分钟以上或搏动停止后结扎脐带）与早期脐带结扎（ECC；在15秒内结扎脐带）。本研究纳入了计划阴道分娩、纯母乳喂养且单胎足月儿以头位分娩的低风险孕妇。主要结局是4个月时血红蛋白的分光光度法估计值。次要结局包括4个月时的贫血发生率、与新生儿黄疸相关的四个结局、血细胞比容水平及相关结局。
结果
总体而言，招募了150名孕妇。参与者（N = 138）被随机分为两组（DCC组n = 68，ECC组n = 70）。两组在4个月时血红蛋白分光光度法估计值无显著差异：平均差异 = 0.1 g/dL，95%置信区间 - 0.14, 0.35，DCC组为12.4 g/dL，ECC组为12.3 g/dL。仅DCC组第3至5天的血细胞比容水平显著高于ECC组：DCC组为57.0%，ECC组为52.6%，平均差异 = 4.4，95%置信区间2.61, 6.20。其他次要结局，包括与新生儿黄疸相关的结局，均无显著差异。
结论
在计划纯母乳喂养的低风险日本足月儿中，与ECC相比，DCC对4个月时分光光度法测定的血红蛋白水平无显著影响。我们观察到接受DCC的婴儿在第3至5天的血细胞比容水平显著更高，而这些水平在正常范围内。黄疸结局与接受ECC的婴儿相似。尽管需要更大样本量来评估脐带结扎对新生儿黄疸的影响，但DCC可能预防新生儿贫血。
试验注册
UMIN-CTR；UMIN000022573，2016年1月6日 - 回顾性注册，https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023056 。
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