Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial.
Resuscitation of very preterm infants with 30% vs. 65% oxygen at birth: study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-13-65
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发表时间：
2012-05-23
期刊：
影响因子：
2.5
通讯作者：
Vermeulen MJ
中科院分区：
文献类型：
--
作者：
Rook D;Schierbeek H;van der Eijk AC;Longini M;Buonocore G;Vento M;van Goudoever JB;Vermeulen MJ
出生时用100%氧气复苏已知会增加氧化负荷，并伴随有害影响。尽管吸入氧分数（FiO 2）< 100%被广泛用于早产儿，但在（太）低FiO 2时开始复苏可能导致缺氧。本研究旨在比较初始FiO 2为30%与65%的极早产儿复苏的安全性和有效性。在这项双盲、随机对照试验中，200名胎龄< 32周的极早产儿将被随机分配至出生后开始复苏，分别给予30%或65%的氧气。将根据脉搏血氧饱和度（SpO 2）和脉率（应超过100次/分钟）测量的氧饱和度调整FiO 2，以在生命10分钟时达到88-94%的目标SpO 2。将连续记录FiO 2和脉搏血氧饱和度数据。主要结局是无支气管肺发育不良的生存率，通过经后36周的生理测试进行评估。次要结局包括达到SpO 2> 88%的时间、5分钟时的Apgar评分、累积O2暴露、氧化应激（通过谷胱甘肽合成和氧化应激标志物确定）、早产儿视网膜病变、脑损伤和2岁时的神经发育结局。本研究将为确定开始极早产儿复苏的适当初始FiO 2提供见解。http://www.trialregister.nl，NTR243.
Resuscitation at birth with 100% oxygen is known to increase the oxidative burden with concomitant deleterious effects. Although fractions of inspired oxygen (FiO2) < 100% are widely used in preterm infants, starting resuscitation at a (too) low FiO2 may result in hypoxia. The objective of this study is to compare the safety and efficacy of resuscitating very preterm infants with an initial FiO2 of 30% versus 65%. In this double-blind, randomized controlled trial, 200 very preterm infants with a gestational age < 32 weeks will be randomized to start resuscitation after birth with either 30% or 65% oxygen. The FiO2 will be adjusted based on oxygen saturation measured by pulse oximetry (SpO2) and pulse rate (which should be over 100 beats per minute) in order to achieve a target SpO2 of 88–94% at 10 min of life. The FiO2 and pulse oximetry data will be continuously recorded. The primary outcome is survival without bronchopulmonary dysplasia, as assessed by a physiological test at 36 weeks postmenstrual age. The secondary outcomes include the time to achieve SpO2 > 88%, Apgar score at 5 min, cumulative O2 exposure, oxidative stress (as determined by glutathione synthesis and oxidative stress markers), retinopathy of prematurity, brain injury and neurodevelopmental outcome at 2 years of age. This study will provide insight into determining the appropriate initial FiO2 to start resuscitation of very preterm infants. http://www.trialregister.nl, NTR243.
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DOI：
10.1016/s0021-9673(01)95945-x
发表时间：
1991-08-09
期刊：
JOURNAL OF CHROMATOGRAPHY
影响因子：
--
作者：
HUSEK, P
通讯作者：
HUSEK, P
影响因子：
2.1
作者：
Rich, Wade D.;Leone, Tina;Finer, Neil N.
通讯作者：
Finer, Neil N.
影响因子：
8
作者：
Vento, Maximo;Moro, Manuel;Asensi, Miguel A.
通讯作者：
Asensi, Miguel A.
影响因子：
5.1
作者：
PAPILE, LA;BURSTEIN, J;KOFFLER, H
通讯作者：
KOFFLER, H
影响因子：
3.9
作者：
Paffetti, Patrizia;Perrone, Serafina;Buonocore, Giuseppe
通讯作者：
Buonocore, Giuseppe