Retinopathy of prematurity

早产儿视网膜病变
  • 文章类型: Journal Article
    目的:定量评估无早产儿视网膜病变(ROP)早产儿视盘周围平均血管弯曲度(mVT)和平均血管宽度(mVW)的变化及其与胎龄(GA)和出生体重(BW)的相关性。
    方法:单中心回顾性研究包括133例(133眼)早产儿[平均校正胎龄(CGA)43.6wk]作为早产儿组,130例(130眼)CGA匹配的足月婴儿作为对照组。使用计算机辅助技术定量测量乳头周围mVT和mVW。
    结果:早产儿的mVT(P=0.0032)和mVW(P=0.0086)明显升高2.68(104cm-3)和1.85µm,分别。GA亚组分析显示,早期早产和中晚期早产组之间的mVT差异有统计学意义(P=0.0244)。但mVW之间差异不显著(P=0.6652)。多元线性回归模型结果显示,调整性别和CGA后,GA和BW与mVT呈显著负相关(分别为P=0.0211和P=0.0006)。出生时GA的每一天增加,mVT减少0.1281(104cm-3),BW每增加1g,mVT减少0.006(104cm-3)。然而,GA(P=0.9402)和BW(P=0.7275)与mVW无显著相关性。
    结论:早产显著影响无ROP早产儿的乳头周围血管参数,提示mVT升高和mVW变窄。这些参数的改变可能为眼部血管疾病的发病机理提供新的见解。
    OBJECTIVE: To quantitatively assess the changes in mean vascular tortuosity (mVT) and mean vascular width (mVW) around the optic disc and their correlation with gestational age (GA) and birth weight (BW) in premature infants without retinopathy of prematurity (ROP).
    METHODS: A single-center retrospective study included a total of 133 (133 eyes) premature infants [mean corrected gestational age (CGA) 43.6wk] without ROP as the premature group and 130 (130 eyes) CGA-matched full-term infants as the control group. The peripapillary mVT and mVW were quantitatively measured using computer-assisted techniques.
    RESULTS: Premature infants had significantly higher mVT (P=0.0032) and lower mVW (P=0.0086) by 2.68 (104 cm-3) and 1.85 µm, respectively. Subgroup analysis with GA showed significant differences (P=0.0244) in mVT between the early preterm and middle to late preterm groups, but the differences between mVW were not significant (P=0.6652). The results of the multiple linear regression model showed a significant negative correlation between GA and BW with mVT after adjusting sex and CGA (P=0.0211 and P=0.0006, respectively). For each day increase in GA at birth, mVT decreased by 0.1281 (104 cm-3) and for each 1 g increase in BW, mVT decreased by 0.006 (104 cm-3). However, GA (P=0.9402) and BW (P=0.7275) were not significantly correlated with mVW.
    CONCLUSIONS: Preterm birth significantly affects the peripapillary vascular parameters that indicate higher mVT and narrower mVW in premature infants without ROP. Alterations in these parameters may provide new insights into the pathogenesis of ocular vascular disease.
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  • 文章类型: Journal Article
    本研究旨在探讨早产儿出生后1个月血清25-羟维生素D(25(OH)D)水平与早产儿视网膜病变(ROP)的相关性。
    选择2017-2022年青岛大学附属医院收治的早产儿(胎龄<32周),根据ROP发生情况分为ROP组和非ROP组。比较两组出生后1个月血清25(OH)D水平及临床资料,并分析维生素D水平与ROP的关系。
    在包括的217名早产儿中,ROP组55例(25.35%),非ROP组162例(74.65%)。ROP组胎龄和出生体重较低,长时间有创通气(IV),无创通气(NIV),与非ROP组相比,氧疗时间。阿普加得分,剖宫产,ROP组的产前类固醇比例较低,而脓毒症和肺表面活性物质利用率较高(均p<0.05)。非ROP组患儿血清25-(OH)D水平差异显著(14.20±5.07ng/ml),ROP治疗组(7.891±1.878ng/ml),和未治疗组(12.168±4.354ng/ml)(p<0.001)。多因素回归分析确定了产前类固醇是保护因素和较低的出生体重,血清25-(OH)D水平,长期有创机械通气,脓毒症是早产儿ROP的独立危险因素。
    维生素D,降低出生体重,长期有创机械通气,脓毒症与早产儿ROP的发生率相关。维生素D与ROP的严重程度有关,强调谨慎补充维生素D和定期监测血清25-(OH)D水平的重要性。
    UNASSIGNED: This study aimed to investigate the correlation between serum 25-hydroxyvitamin D (25(OH)D) levels and retinopathy of prematurity (ROP) in premature infants one month after birth.
    UNASSIGNED: Preterm infants (gestational age <32 weeks) admitted to the Affiliated Hospital of Qingdao University from 2017 to 2022 were divided into ROP and non-ROP groups based on ROP occurrence any stage. Serum 25(OH)D levels and clinical data were compared between the two groups at 1 month after birth, and the relationship between vitamin D levels and ROP was analyzed.
    UNASSIGNED: Among the 217 premature infants included, 55 (25.35%) were in the ROP group, and 162 (74.65%) were in the non-ROP group. The ROP group had lower gestational age and birth weight, longer invasive ventilation (IV), non-invasive ventilation (NIV), and oxygen therapy times compared to the non-ROP group. Apgar scores, cesarean delivery, and antenatal steroids ratios were lower in the ROP group, while sepsis and pulmonary surfactant utilization ratios were higher (all p < 0.05). Significant differences in serum 25-(OH)D levels were observed among children in the non-ROP group (14.20 ± 5.07 ng/ml), ROP treated group (7.891 ± 1.878 ng/ml), and untreated group (12.168 ± 4.354 ng/ml) (p < 0.001). Multivariate regression analysis identified antenatal steroids as protective factors and lower birth weight, serum 25-(OH)D levels, long-term invasive mechanical ventilation, and sepsis as independent risk factors for ROP in premature infants.
    UNASSIGNED: Vitamin D, lower birth weight, long-term invasive mechanical ventilation, and sepsis were associated with incidence of ROP in preterm infants. Vitamin D was associated with the severity of ROP, emphasizing the importance of prudent vitamin D supplementation and regular monitoring of serum 25-(OH)D levels.
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  • 文章类型: Journal Article
    随着撒哈拉以南非洲(SSA)新生儿护理的扩展,越来越多的早产儿有发生早产儿视网膜病变(ROP)的风险.以前的研究已经量化了中等收入国家解决ROP的成本效益,但很少有人关注SSA。与现状相比,这项研究估计了卢旺达国家ROP筛查和抗VEGF注射治疗计划的成本。
    医疗费用数据收集自卢旺达费萨尔国王医院(2022年7月)。视力丧失的社会负担包括生产力损失和质量调整生命年(QALYs)。已发布的ROP流行病学和自然史数据用于估算卢旺达ROP的负担和后遗症。使用决策分析模型将筛查和治疗一年出生队列的国家计划的成本与现状进行了比较。
    ROP筛查和治疗的费用为每名婴儿738美元。启动国家计划所需的设备成本估计为58,667美元。我们预计,与现状相比,一项国家计划可以避免队列中的257例失明病例,并增加QALY。ROP的筛查和治疗将为出生队列节省约270,000美元,以减少生产力损失。
    用于ROP的筛查和抗VEGF治疗的成本大大低于由于ROP引起的视力丧失的间接成本。与目前的做法相比,从社会的角度来看,为扩大ROP筛查和治疗分配额外的资金是节省成本的。
    UNASSIGNED: With the expansion of neonatal care in sub-Saharan Africa (SSA), an increasing number of premature babies are at risk to develop retinopathy of prematurity (ROP). Previous studies have quantified the cost-effectiveness of addressing ROP in middle-income countries, but few have focused on SSA. This study estimates the cost of a national program for ROP screening and anti-VEGF injection treatment in Rwanda compared to the status quo.
    UNASSIGNED: Medical cost data were collected from King Faisal Hospital in Rwanda (July 2022). Societal burden of vision loss included lost productivity and quality-adjusted life years (QALYs). Published data on epidemiology and natural history of ROP were used to estimate burden and sequelae of ROP in Rwanda. Cost of a national program for screening and treating a one-year birth cohort was compared to the status quo using a decision analysis model.
    UNASSIGNED: Cost of ROP screening and treatment was $738 per infant. The estimated equipment cost necessary for the startup of a national program was $58,667. We projected that a national program could avert 257 cases of blindness in the cohort and increase QALYs compared to the status quo. Screening and treatment for ROP would save an estimated $270,000 for the birth cohort from reductions in lost productivity.
    UNASSIGNED: The cost of screening and anti-VEGF treatment for ROP is substantially less than the indirect cost of vision loss due to ROP. Allocating additional funding towards expansion of ROP screening and treatment is cost-saving from a societal perspective compared to current practice.
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  • 文章类型: Journal Article
    背景:这项研究旨在确定在位于印度北部高海拔地区的病态新生儿监护病房(SNCU)接受治疗的“高危”新生儿中早产儿视网膜病变(ROP)的临床特征和危险因素,旨在为制定区域和国家ROP筛查指南做出贡献。
    方法:在2021年至2022年的一项前瞻性观察性研究中,筛选了符合ROP筛查条件的新生儿和新生儿。
    结果:总共39/122名筛查的新生儿接受了1型ROP激光检查,22/39(56.4%)有侵袭性ROP(AROP)。平均出生体重(BW)为1803.87克,平均胎龄为34周。呼吸窘迫,支气管肺发育不良,脓毒症,呼吸暂停占57.3%,13%,52.5%,和25.4%,分别。在28+6周以下,有50%的人存在威胁视力的ROP,27%在29和30+6周之间,52%在31和33+6周之间,和15%的妊娠>34周。两个1型ROP的婴儿体重>2公斤,一个有AROP。经过回归分析,BW<1500g,妊娠<32周,氧气>48小时,临床脓毒症,SNCU总停留时间>14天,持续气道正压通气支持,氧气>50%,>10天达到全食与严重ROP相关。咖啡因治疗呼吸暂停和袋鼠母亲护理降低ROP。没有人出现短期不利结果。
    结论:在大多数SNCU中,类似的基础设施和劳动力短缺,这些发现可以概括。1型和AROP的负担正在增加,如在较高的妊娠和BW中所见。这需要在地方和国家层面修订ROP筛选标准。强调儿科医生和眼科医生合作的重要性至关重要,早期ROP筛查,诊断,和治疗以阻止疾病进展为严重的ROP。
    BACKGROUND: This research aimed to identify the clinical profile and risk factors of retinopathy of prematurity (ROP) among \"at-risk\" newborns treated at a sick newborn care unit (SNCU) located at high altitude in North India, with the intention of contributing to formulate regional and national ROP screening guidelines.
    METHODS: In a prospective observational study from 2021 to 2022, outborn and inborn babies eligible for ROP screening were screened.
    RESULTS: Total 39/122 screened neonates had laser for Type 1 ROP, and 22/39 (56.4%) had aggressive ROP (AROP). The average birth weight (BW) was 1803.87 g, and the average gestational age was 34 weeks. Respiratory distress, bronchopulmonary dysplasia, sepsis, and apnea were present in 57.3%, 13%, 52.5%, and 25.4%, respectively. Sight-threatening ROP was present in 50% below 28+6 weeks, 27% between 29 and 30+6 weeks, 52% between 31 and 33+6 weeks, and 15% with gestation >34 weeks. Two babies with Type 1 ROP weighed >2 kg and one had AROP. Upon regression analysis, BW <1500 g, gestation <32 weeks, oxygen >48 h, clinical sepsis, total SNCU stay >14 days, continuous positive airway pressure support with oxygen >50%, and >10 days to achieve full feeds were associated with severe ROP. Caffeine to treat apnea and kangaroo mother care reduced ROP. None had short-term unfavorable outcome.
    CONCLUSIONS: With similar infrastructure and work force shortage in most SNCUs, these findings can be generalized. The burden of Type 1 and AROP is increasing, as seen in higher gestation and BWs. This needs revision of ROP screening criteria at local and national level. It is crucial to emphasize on the importance of pediatrician and ophthalmologist collaboration, early ROP screening, diagnosis, and treatment to stop disease progression to severe ROP.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    描述在患有早产儿视网膜病变(ROP)的早产儿中观察到的荧光素血管造影(FA)参数。
    回顾性病例系列。
    2014年11月至2022年10月在Holtz儿童医院使用Retcam进行FA成像的ROP患者。
    对纳入患者的荧光血管造影图像进行了分析,重点是血管造影阶段的时机,包括脉络膜冲洗,视网膜,和再循环阶段。妊娠年龄,出生体重(BW),成像年龄,治疗选择,并记录任何FA并发症.
    施用的荧光素剂量,每个血管造影阶段的开始和持续时间,ROP治疗患者的FA结果。
    共观察72只眼睛的72张图像。图像质量被认为适合纳入43例患者的64只眼(88.9%)。出生时的平均胎龄和体重分别为24.4±1.9周和607.8±141.3g,分别。FA成像时的平均月经后年龄为50.5±40.8周。所有眼睛(100%)在平均年龄35.5±2.4周时接受玻璃体内注射抗VEGF治疗。血管造影阶段的开始和持续时间在队列中相对可变。脉络膜冲洗发生在12.2秒的平均时间(范围:6-22秒)。随后的视网膜阶段记录为11.96秒的平均时间(范围:3-22秒)。在荧光素注射后2.15分钟(范围:1-5.45分钟)的平均时间完成再循环阶段。没有患者对荧光素注射产生过敏反应,如皮疹,呼吸窘迫,心动过速,发烧,或局部注射部位反应。
    患有ROP的早产儿FA的血管造影阶段是可变的,并且可能比成人的既定参考更早发生。
    专有或商业披露可在本文末尾的脚注和披露中找到。
    UNASSIGNED: To describe fluorescein angiography (FA) parameters observed in premature neonates with retinopathy of prematurity (ROP).
    UNASSIGNED: Retrospective case series.
    UNASSIGNED: Patients with ROP who underwent FA imaging using Retcam at Holtz Children\'s Hospital from November 2014 to October 2022.
    UNASSIGNED: Fluorescein angiography images of the included patients were analyzed with a focus on the timing of angiography phases, including choroidal flush, retinal, and recirculation phases. Gestational age, birth weight (BW), age at imaging, treatment choice, and any FA complications were documented.
    UNASSIGNED: Dose of fluorescein administered, onset and duration of each angiography phase, and FA findings in ROP-treated patients.
    UNASSIGNED: A total of 72 images of 72 eyes were reviewed. Image quality was deemed suitable for inclusion in 64 eyes (88.9%) of 43 patients. The mean gestational age and BW at birth were 24.4 ± 1.9 weeks and 607.8 ± 141.3 g, respectively. The mean postmenstrual age at FA imaging was 50.5 ± 40.8 weeks. All eyes (100%) received treatment with intravitreal injection of anti-VEGF at a mean age of 35.5 ± 2.4 weeks. The onset and duration of angiography phases were relatively variable within the cohort. Choroidal flush occurred at a mean time of 12.2 seconds (range: 6-22 seconds). A subsequent retinal phase was documented at a mean time of 11.96 seconds (range: 3-22 seconds). Recirculation phase was complete at an average time of 2.15 minutes (range: 1-5.45 minutes) postfluorescein injection. None of patients developed allergic reactions to fluorescein injection, such as rash, respiratory distress, tachycardia, fever, or local injection site reactions.
    UNASSIGNED: Angiographic phases on FA in preterm infants with ROP are variable and may occur earlier than the established references for adults.
    UNASSIGNED: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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  • 文章类型: Journal Article
    背景:早产儿视网膜病变(ROP)是早产儿视力发病的重要原因。该研究的目的是评估早产儿全血细胞计数(CBC)的初始血液学参数与ROP发展之间的关系。
    方法:这项回顾性队列研究在奥里萨邦的新生儿重症监护病房进行。在最初的48小时内进行的CBC的血液学参数,人口特征,新生儿发病率,分析早产儿(胎龄<34周)的ROP筛查结果。在多变量逻辑回归模型中确定了与ROP发展相关的独立危险因素。
    结果:148例新生儿中有43例(29.1%)具有任何ROP阶段(阶段1-26、2-08和3-09)。出生体重(aOR0.003;95%CI0.00,0.11);血红蛋白(Hb)水平(aOR0.70;95%CI0.54,0.90);呼吸窘迫综合征(RDS)的存在(aOR7.61;95%CI1.5,36.39);以及需要输注红细胞(PRBC)(aOR4.26;95%CI1.1,16.44)与ROP发展独立相关。在初始Hb10.5-15.4g/dL的新生儿中,ROP的几率更高(OR(95%CI)3.7(1.5,8.9),p=0.003),对于Hb15.4-17.3g/dL的新生儿(OR(95%CI)2.5(1.01,6.16),p=0.047)与初始Hb>17.3g/dL的新生儿相比。
    结论:出生后早期Hb水平较低的早产儿发生ROP的风险较高,需要优先进行筛查。
    BACKGROUND: Retinopathy of prematurity (ROP) is an important cause of visual morbidity among preterm infants. The objective of the study was to assess the relationship between the initial hematological parameters of the complete blood count (CBC) and ROP development in preterm neonates.
    METHODS: This retrospective cohort study was conducted in a neonatal intensive care unit in Odisha. The hematological parameters of the CBC conducted within the first 48 hours of age, demographic characteristics, neonatal morbidities, and ROP screening findings of preterm neonates (gestational age <34 weeks) were analyzed. Independent risk factors associated with ROP development were identified in a multivariate logistic regression model.
    RESULTS: A total of 43 (29.1%) out of 148 neonates had any of the ROP stages (stage 1-26, 2-08, and 3-09). Birth weight (aOR 0.003; 95% CI 0.00, 0.11);hemoglobin (Hb) level (aOR 0.70; 95% CI 0.54, 0.90); presence of respiratory distress syndrome (RDS) (aOR 7.61; 95% CI 1.5, 36.39); and need for packed red blood cell (PRBC) transfusion (aOR 4.26; 95% CI 1.1, 16.44) were independently associated with ROP development. The odds of ROP were higher among the neonates with initial Hb 10.5-15.4 g/dL (OR (95% CI) 3.7(1.5, 8.9), p=0.003) and for neonates with Hb 15.4-17.3 g/dL (OR (95% CI) 2.5(1.01, 6.16), p=0.047) in comparison to neonates with initial Hb >17.3 g/dL.
    CONCLUSIONS: Preterm neonates with a lower level of Hb during the early postnatal days are at higher risk for ROP development and need to be prioritized for screening.
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  • 文章类型: Journal Article
    早产儿视网膜病(ROP)是一种影响早产儿视网膜的血管疾病。当孵化器中的早产儿暴露于高氧水平时,就会出现这种情况,导致氧化应激,炎症反应,血管内皮生长因子的下调,导致视网膜微血管毛细血管的丢失。回到室内空气后,血管生长因子的上调导致视网膜内皮细胞血管生长异常。如果没有适当的干预,ROP可以进展为失明。ROP的患病率有所上升,使其成为儿童失明的重要原因。目前的治疗方法,如激光治疗和各种药理学方法,受到潜在的严重不良影响的限制。因此,更深入地了解ROP的病理生理学和创新治疗方法的发展势在必行。来自植物的天然产物,真菌,细菌,和海洋生物在治疗各种疾病方面显示出希望,并且由于其最小的副作用和广泛的有益特性,在ROP研究中获得了关注。这篇综述讨论了天然产物在ROP管理中作为治疗剂的作用和机制。
    Retinopathy of prematurity (ROP) is a vascular disorder affecting the retinas of preterm infants. This condition arises when preterm infants in incubators are exposed to high oxygen levels, leading to oxidative stress, inflammatory responses, and a downregulation of vascular endothelial growth factors, which causes the loss of retinal microvascular capillaries. Upon returning to room air, the upregulation of vascular growth factors results in abnormal vascular growth of retinal endothelial cells. Without appropriate intervention, ROP can progress to blindness. The prevalence of ROP has risen, making it a significant cause of childhood blindness. Current treatments, such as laser therapy and various pharmacologic approaches, are limited by their potential for severe adverse effects. Therefore, a deeper understanding of ROP\'s pathophysiology and the development of innovative treatments are imperative. Natural products from plants, fungi, bacteria, and marine organisms have shown promise in treating various diseases and have gained attention in ROP research due to their minimal side effects and wide-ranging beneficial properties. This review discusses the roles and mechanisms of natural products that hold potential as therapeutic agents in ROP management.
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  • 文章类型: Journal Article
    探讨1型早产儿视网膜病变(ROP)患者在校正年龄6岁时玻璃体腔注射(IVI)雷珠单抗(R)和贝伐单抗(B)的生物识别和屈光检查结果。这是一项单中心回顾性研究。包括诊断为1型ROP并以R或B的IVI作为主要疗法的婴儿。轴向长度数据,前房深度(ACD),和晶状体厚度(LT)使用A扫描超声获得。晶状体麻痹屈光,角膜曲率测量(K),并记录了最佳矫正视力。此外,进行光学相干断层扫描血管造影以评估中央凹无血管区以及浅血管和深血管的密度。我们分析了两组之间的结构和功能差异,并将其与先前研究中这些儿童在1至3岁之间的研究结果进行了比较。该研究包括34名患者的60只眼睛,34只眼接受B,26只眼接受R注射进行ROP。在生物识别结果中,R组仍有较深的ACD(B组3.36±0.24mm;R组3.52±0.21mm)和较薄的LT(B组3.63±0.16mm;R组3.53±0.12mm),正如以前在3岁时报道的那样。在折射方面,用B治疗的眼睛在1岁和3岁时近视较高;然而,6岁时,两组间屈光不正无显著差异.在校正的6岁时,用R的IVI治疗的眼睛与更深的ACD和更薄的LT相关。有趣的是,正视化过程导致6岁时高度近视的发生率相似,这与年轻时观察到的结果不同.
    To investigate biometric and refractive results in patients with type 1 retinopathy of prematurity (ROP) treated by intravitreal injection (IVI) of ranibizumab (R) and bevacizumab (B) at the corrected age of 6. This is a single-center retrospective study. Infants diagnosed with type 1 ROP and treated with IVI of either R or B as the primary therapy were included. Data on axial length, anterior chamber depth (ACD), and lens thickness (LT) were obtained using A-scan ultrasound. Cycloplegic refraction, keratometry (K), and best-corrected visual acuity were also documented. Additionally, optical coherence tomography angiography was performed to assess the foveal avascular zone and the density of superficial and deep vessels. We analyzed the structural and functional differences between the 2 groups and compared them with findings from a previous study conducted when these children were between the ages of 1 and 3. The study included 60 eyes from 34 patients, with 34 eyes receiving B and 26 eyes receiving R injections for ROP. In biometric outcomes, there was still a deeper ACD (3.36 ± 0.24 mm in the B group; 3.52 ± 0.21 mm in the R group) and thinner LT (3.63 ± 0.16 mm in the B group; 3.53 ± 0.12 mm in the R group) in the R group, as previously reported at the age of 3. In the refractive aspect, the eyes treated with B had higher myopia at the ages of 1 and 3; however, at the age of 6, refractive errors did not differ significantly between the 2 groups. At the corrected age of 6, the eyes treated with IVI of R were associated with deeper ACD and thinner LT. Interestingly, the emmetropization process resulted in a similar incidence of high myopia at the age of 6, which was different from the outcomes observed at younger ages.
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    背景:早产儿视网膜病变(ROP)的风险很高,有潜在的终身视力障碍。低胎儿血红蛋白(HbF)水平预测ROP。尚不清楚防止HbF降低是否也降低ROP。
    方法:BORN是一项正在进行的多中心双盲随机对照试验,研究输注富含HbF的脐带血红细胞(CB-RBC)而不是成人供体红细胞单位(A-RBC)是否可以降低严重ROP的发生率(NCT05100212)。出生在妊娠24至27+6周之间的新生儿被招募,并以1:1的比例随机分配接受成人供体RBC(A-RBC,A组)或从出生到月经后年龄(PMA)为31+6周的同种异体CB-RBC(B组)。主要结果是PMA或出院40周时严重ROP的发生率,样本量为146名患者。在纳入前58名患者后,安排了预先指定的中期分析,主要目的是评价CB-RBC输血的安全性。
    结果:报告了意向治疗和符合方案分析的结果。28名患者在A臂,30名患者在B臂。输注104个A-RBC单位和49个CB-RBC单位,协议偏差率很高。共记录了336起不良事件,两组的发病率和严重程度相似。通过符合协议的分析,接受A-RBC或两种类型的RBC的患者比未输血患者或仅输注CB-RBC的患者经历了更多的不良事件,患有更严重的心动过缓,肺动脉高压,和血流动力学显著动脉导管未闭。血清钾,乳酸,CB-RBC或A-RBC后的pH值相似。14例患者死亡,44例接受ROP评估。其中十个发生了严重的ROP,武器之间没有区别。在符合方案分析中,与CB-RBC相比,每次A-RBC输血的严重ROP相对风险为1.66(95%CI1.06-2.20)。HbF曲线下面积表明,PMA前30周HbF下降对严重的ROP发展至关重要。随后的CB-RBC输血不会降低ROP风险。
    结论:中期分析表明,早产新生儿的CB-RBC输血策略是安全的,如果早期采用,可以保护他们免受严重的ROP。
    背景:于2021年10月29日在ClinicalTrials.gov进行了前瞻性注册。标识符号NCT05100212。
    BACKGROUND: Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP.
    METHODS: BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions.
    RESULTS: Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06-2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk.
    CONCLUSIONS: The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP.
    BACKGROUND: Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212.
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