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Early versus delayed cord clamping in small for gestational age infants and iron stores at 3 months of age - a randomized controlled trial

机译:早期与延迟绳夹紧在胎龄婴儿和铁储存在3个月的婴儿和铁储存 - 一个随机对照试验

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摘要

Abstract Background Delayed cord clamping is the standard of care in infants not requiring resuscitation; however effects of cord clamping strategies have not been evaluated systematically in small for gestational age (SGA) infants. The primary objective was to compare effects of delayed cord clamping (DCC) and early cord clamping (ECC) on serum ferritin at 3 months in SGA infants born at ≥35 weeks. The secondary objectives were to compare hematological parameters, clinical outcomes in neonatal period and growth at 3 months of age. Methods All eligible infants with fetal growth restriction were randomized to two groups, DCC at 60 s or ECC group in which the cord was clamped immediately after birth. Results Total of 142 infants underwent randomization and subsequently 113 infants underwent definite inclusion. At 3 months, the median (IQR) serum ferritin levels were higher in DCC group, compared to ECC; 86 ng/ml (43.35–134.75) vs 50.5 ng/ml (29.5–83.5), p = 0.01. Fewer infants had iron deficiency in DCC group compared to ECC group; 9 (23.6%) vs 21 (47.7%), p = 0.03 [NNT being 4; 95% CI (2–25)].The proportion of infants with polycythemia was significantly higher in DCC group; 23 (41.81) % vs 12 (20.6%), p = 0.01. There was no difference in proportion of infants with symptomatic polycythemia or those who underwent partial exchange transfusions. Clinical outcomes and mortality were similar. Conclusions DCC improves iron stores in SGA infants ≥35 weeks at 3 months of age without increasing the risk of symptomatic polycythemia, need for partial exchange transfusions or morbidities associated with polycythemia. Trial registration Our trial was retrospectively registered on 29th May 2015 through Clinical trials registry India. Registration number: CTRI 2015/05/005828.
机译:摘要背景延迟绳夹紧是婴儿不需要复苏的护理标准;然而,对于孕龄(SGA)婴儿,尚未系统地评估了脐带钳位策略的影响。主要目的是在SGA婴儿出生于≥35周的SGA婴儿3个月内比较延迟帘线夹紧(DCC)和早期脐带夹紧(ECC)对血清铁蛋白的影响。次要目标是比较血液学参数,新生儿期间的临床结果,3个月的年龄增长。方法对胎儿生长限制的所有符合条件的婴儿随机分为两组,DCC在60秒或ECC组中,其中帘线在出生后立即夹紧。结果总共142名婴幼儿随机化,随后113个婴儿接受了明确的包容性。 3个月,与ECC相比,DCC组中位数(IQR)血清铁蛋白水平较高; 86 ng / ml(43.35-134.75)与50.5ng / ml(29.5-83.5),p = 0.01。与ECC集团相比,DCC组的缺乏缺乏缺乏症; 9(23.6%)与21(47.7%),P = 0.03 [NNT为4; 95%CI(2-25)]。DCC集团在多发性肾病症的比例显着高; 23(41.81)%Vs 12(20.6%),p = 0.01。患有症状性多胆症的婴儿或接受部分交换输血的人的比例没有差异。临床结果和死亡率相似。结论DCC在3个月的3个月内改善了SGA婴儿的铁储存,而不增加症状性多胆症的风险,需要部分交换输血或与多循环血症相关的病症。试验注册我们的审判通过2015年5月29日通过临床试验登记印度注册。注册号:CTRI 2015/05/005828。

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