Department of Neonatology, Government Medical College Hospital, Chandigarh, India.
Department of Neonatology, Government Medical College Hospital, Chandigarh, India.
J Pediatr. 2023 Mar;254:54-60.e4. doi: 10.1016/j.jpeds.2022.08.061. Epub 2022 Oct 18.
To compare the effect of intact cord versus clamped cord resuscitation on the physiologic transition of neonates receiving positive-pressure ventilation (PPV) at birth.
This open-label, parallel-group, randomized controlled superiority trial was conducted in a tertiary care hospital in India. Neonates born at ≥34 weeks of gestation after a complicated pregnancy or labor were randomized just before birth to receive resuscitation according to the Neonatal Resuscitation Program algorithm with either an intact cord (intact cord resuscitation group) or after early cord clamping (early cord clamping resuscitation group). The allocated study intervention was administered if the neonate needed PPV at birth. The primary outcome was expanded Apgar score at 5 minutes after birth.
Birth weight, gestational age, and the incidence of pregnancy complications were similar in the 2 study groups. The proportion of neonates who received PPV was lower in the intact cord resuscitation group (28.7% vs 36.5%, P = .05; relative risk, 0.79; 95% CI, 0.61-1.01). Among neonates who received PPV, the expanded Apgar score at 5 minutes was significantly higher in the intact cord resuscitation group (median, 15 [IQR, 14-15] vs 14 [IQR, 13-15]; P < .001). The expanded Apgar score at 10 minutes, Apgar scores at 5 and 10 minutes, and oxygen saturation at 1, 5, and 10 minutes were also higher in the intact cord resuscitation group.
In late preterm and term neonates, resuscitation with an intact cord results in better postnatal physiologic transition than the standard practice of resuscitation after immediate cord clamping.
Clinical Trial Registry of India (www.ctri.nic.in); trial registration no. CTRI/2020/02/023379.
比较在出生时接受正压通气（PPV）的新生儿中，完整脐带与夹闭脐带复苏对其生理过渡的影响。
这是一项在印度一家三级保健医院进行的开放性、平行组、随机对照优效性试验。妊娠或分娩过程复杂的胎龄≥34 周的新生儿在出生前随机分为两组，根据新生儿复苏方案的算法接受复苏，一组为保留脐带（保留脐带复苏组），另一组为早期脐带夹闭（早期脐带夹闭复苏组）。如果新生儿在出生时需要行 PPV，则给予分配的研究干预措施。主要结局为出生后 5 分钟时扩展的 Apgar 评分。
两组的出生体重、胎龄和妊娠并发症发生率相似。保留脐带复苏组接受 PPV 的新生儿比例较低（28.7%比 36.5%，P=0.05；相对风险，0.79；95%CI，0.61-1.01）。在接受 PPV 的新生儿中，保留脐带复苏组出生后 5 分钟时扩展的 Apgar 评分显著较高（中位数，15[IQR，14-15]比 14[IQR，13-15]；P<0.001）。保留脐带复苏组出生后 10 分钟的扩展 Apgar 评分、5 分钟和 10 分钟时的 Apgar 评分以及 1 分钟、5 分钟和 10 分钟时的氧饱和度也较高。
在晚期早产儿和足月儿中，与立即夹闭脐带的标准复苏实践相比，使用完整脐带进行复苏可带来更好的出生后生理过渡。
印度临床试验注册处（www.ctri.nic.in）；试验注册号 CTRI/2020/02/023379。
