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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儿年龄婴儿和3个月龄的婴儿和铁储存中 - 一个随机对照试验

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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. 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. 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. 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. Our trial was retrospectively registered on 29th May 2015 through Clinical trials registry India. Registration number: CTRI 2015/05/005828 .
机译:延迟线钳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。主要目的是将延迟帘线夹紧(DCC)和早期帘线钳位(ECC)对血清铁蛋白的影响进行比较,在≥35次出生于≥35次的SGA婴幼儿中。次要目标是比较血液学参数,新生儿期间的临床结果,并在3个月龄的年龄增长。所有符合胎儿生长限制的婴儿都随机分为两组,DCC为60?S或ECC组,其中帘线在出生后立即夹紧。总共142名婴儿随机化,随后113个婴儿接受了明确的纳入。 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50.5?ng / 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%)Vs 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。 DCC在SGA婴儿中改善了铁储存≥35?周年3个月的时间,而不增加症状性多胆症风险,需要与多胆症相关的部分交换输血或病态。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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