PDF(Pubmed)
Abstract：
UNASSIGNED: Observational studies often report that anemia and red blood cell (RBC) transfusions are associated with a higher risk of necrotizing enterocolitis (NEC) among extremely low-birthweight (ELBW) infants.
UNASSIGNED: To evaluate whether there is a temporal association between 72-hour hazard periods of exposure to RBC transfusions and NEC among ELBW infants randomized to either higher or lower hemoglobin transfusion thresholds.
UNASSIGNED: This post hoc secondary analysis of 1690 ELBW infants who survived to postnatal day 10 enrolled in the Transfusion of Prematures (TOP) randomized multicenter trial between December 1, 2012, and April 12, 2017, was performed between June 2021 and July 2023.
UNASSIGNED: First, the distribution of RBC transfusions and the occurrence of NEC up to postnatal day 60 were examined. Second, 72-hour posttransfusion periods were categorized as hazard periods and the pretransfusion periods of variable duration as control periods. Then, the risk of NEC in posttransfusion hazard periods was compared with that in pretransfusion control periods, stratifying the risk based on randomization group (higher or lower hemoglobin transfusion threshold group).
UNASSIGNED: The primary outcome was incidence of NEC stage 2 or 3. Secondary outcomes included the incidence rates of NEC within five 10-day intervals, taking into account the number of days at risk.
UNASSIGNED: Of 1824 ELBW infants randomized during the TOP trial, 1690 were included in the present analysis (mean [SD] gestational age, 26.0 [1.5] weeks; 899 infants [53.2%] were female). After categorizing 4947 hazard periods and 5813 control periods, we identified 133 NEC cases. Fifty-nine of these cases (44.4%) occurred during hazard periods. Baseline and clinical characteristics of infants with NEC during hazard periods did not differ from those of infants with NEC during control periods. The risk of NEC was 11.9 per 1000 posttransfusion hazard periods and 12.7 per 1000 control periods (adjusted risk ratio, 0.95; 95% CI, 0.68-1.32; P = .74). This risk did not differ significantly between randomization groups, but the incidence rate of NEC per 1000 days peaked between postnatal days 20 and 29 in the lower hemoglobin transfusion threshold group.
UNASSIGNED: The findings of this post hoc analysis suggest that, among ELBW infants with the hemoglobin ranges occurring in the TOP trial, exposure to RBC transfusions was not temporally associated with a higher risk of NEC during 72-hour posttransfusion hazard periods. Given that the incidence rate of NEC peaked between postnatal days 20 and 29 among infants with lower hemoglobin values, a more in-depth examination of this at-risk period using larger data sets is warranted.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT01702805.
UNASSIGNED: To evaluate whether there is a temporal association between 72-hour hazard periods of exposure to RBC transfusions and NEC among ELBW infants randomized to either higher or lower hemoglobin transfusion thresholds.
UNASSIGNED: This post hoc secondary analysis of 1690 ELBW infants who survived to postnatal day 10 enrolled in the Transfusion of Prematures (TOP) randomized multicenter trial between December 1, 2012, and April 12, 2017, was performed between June 2021 and July 2023.
UNASSIGNED: First, the distribution of RBC transfusions and the occurrence of NEC up to postnatal day 60 were examined. Second, 72-hour posttransfusion periods were categorized as hazard periods and the pretransfusion periods of variable duration as control periods. Then, the risk of NEC in posttransfusion hazard periods was compared with that in pretransfusion control periods, stratifying the risk based on randomization group (higher or lower hemoglobin transfusion threshold group).
UNASSIGNED: The primary outcome was incidence of NEC stage 2 or 3. Secondary outcomes included the incidence rates of NEC within five 10-day intervals, taking into account the number of days at risk.
UNASSIGNED: Of 1824 ELBW infants randomized during the TOP trial, 1690 were included in the present analysis (mean [SD] gestational age, 26.0 [1.5] weeks; 899 infants [53.2%] were female). After categorizing 4947 hazard periods and 5813 control periods, we identified 133 NEC cases. Fifty-nine of these cases (44.4%) occurred during hazard periods. Baseline and clinical characteristics of infants with NEC during hazard periods did not differ from those of infants with NEC during control periods. The risk of NEC was 11.9 per 1000 posttransfusion hazard periods and 12.7 per 1000 control periods (adjusted risk ratio, 0.95; 95% CI, 0.68-1.32; P = .74). This risk did not differ significantly between randomization groups, but the incidence rate of NEC per 1000 days peaked between postnatal days 20 and 29 in the lower hemoglobin transfusion threshold group.
UNASSIGNED: The findings of this post hoc analysis suggest that, among ELBW infants with the hemoglobin ranges occurring in the TOP trial, exposure to RBC transfusions was not temporally associated with a higher risk of NEC during 72-hour posttransfusion hazard periods. Given that the incidence rate of NEC peaked between postnatal days 20 and 29 among infants with lower hemoglobin values, a more in-depth examination of this at-risk period using larger data sets is warranted.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT01702805.
摘要：
观察性研究经常报道，贫血和红细胞（RBC）输血与极低出生体重（ELBW）婴儿发生坏死性小肠结肠炎（NEC）的风险更高。
■评估随机分配至更高或更低血红蛋白输血阈值的ELBW婴儿中，暴露于RBC输血和NEC的72小时危险期之间是否存在时间关联。
■这项对2012年12月1日至2017年4月12日在早产输血（TOP）随机多中心试验中存活至出生后第10天的1690名ELBW婴儿的事后二次分析在2021年6月至2023年7月之间进行。
■首先，研究了截至出生后第60天的RBC输血分布和NEC发生情况.第二,输血后72小时被归类为危险期，而可变持续时间的输血前期被归类为对照期。然后，将输血后危险期的NEC风险与输血前控制期的NEC风险进行比较,根据随机分组(血红蛋白输血阈值较高或较低的组)对风险进行分层.
■主要结局是NEC2或3期的发生率。次要结果包括五个10天间隔内NEC的发生率，考虑到风险的天数。
■在TOP试验中随机分配的1824名ELBW婴儿中，本分析包括1690例(平均[SD]胎龄，26.0[1.5]周；899名婴儿[53.2%]为女性）。在对4947个危险期和5813个控制期进行分类后，我们确定了133例NEC病例。其中59例(44.4%)发生在危险时期。在危险时期，NEC婴儿的基线和临床特征与对照时期NEC婴儿的基线和临床特征没有差异。NEC的风险为每1000个输血后危险期11.9个，每1000个控制期12.7个（调整后的风险比，0.95；95%CI，0.68-1.32；P=.74）。随机分组之间的风险没有显着差异，但在低血红蛋白输注阈值组中,每1000天NEC的发生率在出生后第20天至第29天达到峰值.
■这项事后分析的结果表明，在TOP试验中出现血红蛋白范围的ELBW婴儿中，在输血后72小时危险期,接受RBC输血在时间上与NEC的高风险无关.鉴于NEC的发病率在出生后第20天和第29天之间在血红蛋白值较低的婴儿中达到峰值，有必要使用更大的数据集对这一危险期进行更深入的检查.
■ClinicalTrials.gov标识符：NCT01702805。
■评估随机分配至更高或更低血红蛋白输血阈值的ELBW婴儿中，暴露于RBC输血和NEC的72小时危险期之间是否存在时间关联。
■这项对2012年12月1日至2017年4月12日在早产输血（TOP）随机多中心试验中存活至出生后第10天的1690名ELBW婴儿的事后二次分析在2021年6月至2023年7月之间进行。
■首先，研究了截至出生后第60天的RBC输血分布和NEC发生情况.第二,输血后72小时被归类为危险期，而可变持续时间的输血前期被归类为对照期。然后，将输血后危险期的NEC风险与输血前控制期的NEC风险进行比较,根据随机分组(血红蛋白输血阈值较高或较低的组)对风险进行分层.
■主要结局是NEC2或3期的发生率。次要结果包括五个10天间隔内NEC的发生率，考虑到风险的天数。
■在TOP试验中随机分配的1824名ELBW婴儿中，本分析包括1690例(平均[SD]胎龄，26.0[1.5]周；899名婴儿[53.2%]为女性）。在对4947个危险期和5813个控制期进行分类后，我们确定了133例NEC病例。其中59例(44.4%)发生在危险时期。在危险时期，NEC婴儿的基线和临床特征与对照时期NEC婴儿的基线和临床特征没有差异。NEC的风险为每1000个输血后危险期11.9个，每1000个控制期12.7个（调整后的风险比，0.95；95%CI，0.68-1.32；P=.74）。随机分组之间的风险没有显着差异，但在低血红蛋白输注阈值组中,每1000天NEC的发生率在出生后第20天至第29天达到峰值.
■这项事后分析的结果表明，在TOP试验中出现血红蛋白范围的ELBW婴儿中，在输血后72小时危险期,接受RBC输血在时间上与NEC的高风险无关.鉴于NEC的发病率在出生后第20天和第29天之间在血红蛋白值较低的婴儿中达到峰值，有必要使用更大的数据集对这一危险期进行更深入的检查.
■ClinicalTrials.gov标识符：NCT01702805。
