Abstract
BackgroundJapanese 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.MethodsWe 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.ResultsOverall, 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.ConclusionAmong 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 registrationUMIN-CTR; UMIN000022573, 06/01/2016 - retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023056
Highlights
Japanese infants have relatively higher risk of anemia and neonatal jaundice
Baseline characteristics Between December 2015 and June 2016, a total of 263 women were screened for eligibility, and almost half (n = 125) were excluded after either not meeting the inclusion criteria (n = 71) or declining to participate in the study (n = 42) or not able to deliver at study facility (n = 12)
In this study, we found that delayed cord clamping (DCC) had no significant effect on spectrophotometric hemoglobin (SpHb) levels at 4 months compared with early cord clamping (ECC)
Summary
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. Several randomized controlled trials have been conducted to clarify the effects of delayed cord clamping (DCC) on the prevention of anemia in infancy. In East Asia, Chinese and Taiwanese studies reported no significant effects on jaundice-related outcomes of total serum bilirubin (TsB) [7, 8]; a Cochrane systematic review including unpublished data concluded that DCC may increase the risk of neonates requiring phototherapy [9]. A recent observational study reported no significant association between the timing of umbilical cord clamping, infant anemia at 3 to 5 months, and neonatal jaundice [15]. It is important to update the review for term infants, and the results of this study may contribute to this process by providing new clinical trial information
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