JAUNDICE, NEONATAL

黄疸,新生儿
  • 文章类型: Journal Article
    本研究的目的是研究光疗治疗对足月新生儿血清褪黑激素水平的影响。
    这项研究计划作为单中心,prospective,观察,病例对照研究。由于黄疸而接受至少6小时光疗的足月婴儿(妊娠周≥37周)构成光疗组,而无黄疸和纯母乳喂养的足月婴儿构成对照组。通过在晚上02:00从两组的婴儿中采集血液样本来检查褪黑激素水平。比较两组间的褪黑素值。研究了光疗对血清褪黑素水平的影响。研究了光疗持续时间与最大血清胆红素值与褪黑激素值之间的关系。
    该研究包括70名足月儿(64.3%为女孩)。平均孕周38.3±1.1周,平均出生体重为3295±434g。光疗组与对照组在性别方面无统计学差异,交货类型,孕周,出生体重,高度,头围(p均>0.05)。光疗组血清褪黑素水平为20.3±5.9pg/mL(范围:8.7-36.6pg/mL),对照组为19.9±4.38pg/mL(范围:9.9-26.3pg/mL)。在血清褪黑素水平方面,两组之间没有显着差异(p=0.155)。平均总胆红素值为17.65±1.48mg/dL,光疗组婴儿的平均光疗时间为13.94±7.64h。光疗应用的持续时间与血清褪黑激素水平之间没有发现相关性(p=0.791)。
    确定由于黄疸而接受光疗至少6小时的足月新生儿的血清褪黑激素水平没有显着差异。光疗应用的持续时间与最大胆红素值的血清褪黑激素水平之间没有相关性。
    UNASSIGNED: The aim of this study was to investigate the effect of phototherapy treatment on serum melatonin levels in term newborn infants.
    UNASSIGNED: This study was planned as a single-center, prospective, observational, case-control study. Term infants (gestation week ≥37 weeks) who received at least 6 h of phototherapy due to jaundice constitute the phototherapy group, while the term infants without jaundice and who were exclusively breastfed constitute the control group. Melatonin levels were examined by taking blood samples from babies in both groups at 02:00 at night. Melatonin values were compared between groups. The effect of phototherapy on serum melatonin levels was investigated. The relationship between the duration of phototherapy and maximum serum bilirubin values on melatonin values was investigated.
    UNASSIGNED: Seventy term infants (64.3% girls) were included in the study. Mean gestational week was 38.3 ± 1.1 weeks, mean birth weight was 3295 ± 434 g. There was no statistically significant difference between the phototherapy group and the control group in terms of sex, type of delivery, gestational week, birth weight, height, and head circumference (all p > 0.05). Serum melatonin level was 20.3 ± 5.9 pg/mL (range: 8.7-36.6 pg/mL) in the phototherapy group and 19.9 ± 4.38 pg/mL (range: 9.9-26.3 pg/mL) in the control group. There was no significant difference between the two groups in terms of serum melatonin levels (p = 0.155). The mean total bilirubin value was 17.65 ± 1.48 mg/dL, and the average duration of phototherapy application was 13.94 ± 7.64 h in the babies in the phototherapy group. No correlation was found between the duration of phototherapy application and serum melatonin levels (p = 0.791).
    UNASSIGNED: It was determined that there was no significant difference in serum melatonin levels in term newborn babies who received phototherapy for at least 6 h due to jaundice. No correlation was found between the duration of phototherapy application and the serum melatonin level of the maximum bilirubin values.
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  • 文章类型: Journal Article
    评估2014年至2019年高危产妇中宏观新生儿(出生体重超过4000克)的患病率,以及所涉及的产妇特征,危险因素,交付方式和相关结果,比较体重4000-4500克的新生儿和体重在4500克以上的新生儿。
    这是一项观察性研究,案例控制类型,通过在医院自己的系统和临床记录中搜索数据来进行。纳入研究的标准是在2014年1月至2019年12月期间监测的所有新生儿出生体重等于或大于4000克的患者,随后分为两个亚组(4000至4500克的新生儿和4500克以上的新生儿)。收集后,变量被转录到数据库中,排列在频率表中。为了对数据进行处理和统计分析,使用Excel和R软件。该工具用于创建有助于解释结果的图形和表格。收集的变量的统计分析包括简单的描述性分析和推断统计,单变量,双变量和多变量分析。
    从2014年到2019年,3.3%的分娩是宏观新生儿。出生时平均胎龄为39.4周。最常见的分娩方式(65%)是剖宫产。研究的分娩中有30%存在糖尿病,大多数患者缺乏血糖控制。在阴道分娩中,只有6%的患者接受了仪器检查,21%的患者有肩难产。大多数新生儿(62%)有一些并发症,黄疸(35%)是最常见的。
    出生体重超过4000克对新生儿并发症的发生具有统计学意义,如低血糖,呼吸窘迫和第5分钟APGAR小于7,特别是如果出生体重超过4500克。孕龄也显示与新生儿并发症有统计学意义的相关,较低的,风险越大。因此,巨大儿与并发症密切相关,尤其是新生儿并发症.
    UNASSIGNED: Evaluate the prevalence of macrosomic newborns (birth weight above 4000 grams) in a high-risk maternity from 2014 to 2019, as well as the maternal characteristics involved, risk factors, mode of delivery and associated outcomes, comparing newborns weighing 4000-4500 grams and those weighing above 4500 grams.
    UNASSIGNED: This is an observational study, case-control type, carried out by searching for data in hospital\'s own system and clinical records. The criteria for inclusion in the study were all patients monitored at the service who had newborns with birth weight equal than or greater than 4000 grams in the period from January 2014 to December 2019, being subsequently divided into two subgroups (newborns with 4000 to 4500 grams and newborns above 4500 grams). After being collected, the variables were transcribed into a database, arranged in frequency tables. For treatment and statistical analysis of the data, Excel and R software were used. This tool was used to create graphs and tables that helped in the interpretation of the results. The statistical analysis of the variables collected included both simple descriptive analyzes as well as inferential statistics, with univariate, bivariate and multivariate analysis.
    UNASSIGNED: From 2014 to 2019, 3.3% of deliveries were macrosomic newborns. The average gestational age in the birth was 39.4 weeks. The most common mode of delivery (65%) was cesarean section. Diabetes mellitus was present in 30% of the deliveries studied and glycemic control was absent in most patients. Among the vaginal deliveries, only 6% were instrumented and there was shoulder dystocia in 21% of the cases. The majority (62%) of newborns had some complication, with jaundice (35%) being the most common.
    UNASSIGNED: Birth weight above 4000 grams had a statistically significant impact on the occurrence of neonatal complications, such as hypoglycemia, respiratory distress and 5th minute APGAR less than 7, especially if birth weight was above 4500 grams. Gestational age was also shown to be statistically significant associated with neonatal complications, the lower, the greater the risk. Thus, macrosomia is strongly linked to complications, especially neonatal complications.
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  • 文章类型: Journal Article
    目的:研究盆浴对接受隧道和发光二极管光疗的新生儿皮肤和胆红素水平的影响。
    方法:在这项随机对照试验中,使用计算机程序将诊断为高胆红素血症的住院新生儿用隧道或发光二极管装置治疗,随机分配至实验组(沐浴)或对照组(无沐浴).使用光疗后6、12和24小时的新生儿皮肤状况评分记录所有组的皮肤完整性水分平衡。和他们的血清总胆红素测量进行了评估。
    结果:在婴儿血清总胆红素水平中观察到统计学上的显着差异;这种下降在实验组中最高。Further,实验组的皮肤完整性-水分平衡高于对照组;隧道实验组最高,隧道对照组最低。
    结论:这些结果表明,沐浴可有效降低总胆红素水平。这项研究增加了光疗期间沐浴的新生儿的皮肤完整性和水分平衡的证据。
    OBJECTIVE: To investigate the effects of tub bathing on the skin and bilirubin levels of newborns receiving tunnel and light-emitting diode phototherapy.
    METHODS: In this randomized controlled trial, hospitalized newborns diagnosed with hyperbilirubinemia treated with a tunnel or light-emitting diode device were randomly assigned to either the experimental (bath) or control (no bath) groups using a computer program. The skin integrity moisture balance of all groups was recorded using the Newborn Skin Condition Score at 6, 12, and 24 hours after phototherapy, and their total serum bilirubin measurements were evaluated.
    RESULTS: A statistically significant difference was observed in the babies\' total serum bilirubin levels; this decrease was the highest in the experimental groups. Further, the skin integrity-moisture balance was higher in the experimental groups than in the control groups; it was highest in the tunnel-experimental group and lowest in the tunnel control group.
    CONCLUSIONS: These results show that bathing is effective in reducing total bilirubin levels. This study adds to the evidence on skin integrity and moisture balance in newborns who were bathed during phototherapy.
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  • 文章类型: Journal Article
    背景:新生儿黄疸是新生儿常见且危及生命的健康问题,原因是循环中未结合胆红素的过度积累。肠道菌群对胆红素代谢有潜在影响。婴儿肠道微生物组通常从母体肠道复制。在怀孕期间,由于饮食习惯的改变,荷尔蒙和体重,产妇肠道菌群失调很常见,可以通过补充益生菌来稳定。然而,益生菌补充剂是否可以通过母亲接触到婴儿并减少新生儿黄疸的发生率,目前还没有研究。因此,我们旨在评估产前孕妇补充益生菌对新生儿黄疸发生率的影响。
    方法:这是一项随机双盲安慰剂对照临床试验,在香港一家三级医院的94名孕妇(每组47名)中进行。自愿符合条件的参与者将在妊娠28至35周之间招募。将进行计算机生成的随机化和分配给干预组或对照组。参与者将每天服用一袋Vivomixx(每袋4500亿个菌落形成单位)或安慰剂,直到产后1周。研究参与者和研究人员都不知道随机化和分配。干预将在妊娠36周开始。将测量新生儿胆红素水平以确定主要结果(高胆红素血症),而母乳和母婴粪便样本的宏基因组微生物组谱以及妊娠结局将是次要结果。将进行二元逻辑和线性回归以评估微生物组数据与不同临床结果的关联。
    背景:伦理批准已获得中大-NTEC联合临床研究伦理委员会,香港(CREC编号:2023.100-T)。研究结果将发表在同行评审的期刊上,并在国际会议上发表。
    背景:NCT06087874。
    BACKGROUND: Neonatal jaundice is a common and life-threatening health problem in neonates due to overaccumulation of circulating unconjugated bilirubin. Gut flora has a potential influence on bilirubin metabolism. The infant gut microbiome is commonly copied from the maternal gut. During pregnancy, due to changes in dietary habits, hormones and body weight, maternal gut dysbiosis is common, which can be stabilised by probiotics supplementation. However, whether probiotic supplements can reach the baby through the mother and reduce the incidence of neonatal jaundice has not been studied yet. Therefore, we aim to evaluate the effect of prenatal maternal probiotic supplementation on the incidence of neonatal jaundice.
    METHODS: This is a randomised double-blind placebo-controlled clinical trial among 94 pregnant women (47 in each group) in a tertiary hospital in Hong Kong. Voluntary eligible participants will be recruited between 28 and 35 weeks of gestation. Computer-generated randomisation and allocation to either the intervention or control group will be carried out. Participants will take either one sachet of Vivomixx (450 billion colony-forming units per sachet) or a placebo per day until 1 week post partum. Neither the study participants nor researchers will know the randomisation and allocation. The intervention will be initiated at 36 weeks of gestation. Neonatal bilirubin level will be measured to determine the primary outcome (hyperbilirubinaemia) while the metagenomic microbiome profile of breast milk and maternal and infant stool samples as well as pregnancy outcomes will be secondary outcomes. Binary logistic and linear regressions will be carried out to assess the association of the microbiome data with different clinical outcomes.
    BACKGROUND: Ethics approval is obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee, Hong Kong (CREC Ref: 2023.100-T). Findings will be published in peer-reviewed journals and presented at international conferences.
    BACKGROUND: NCT06087874.
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  • 文章类型: Journal Article
    目的:探讨妊娠期乙型肝炎病毒(HBV)感染的关系,抗病毒治疗,和妊娠结局。
    方法:回顾性选择2016年10月1日至2020年10月1日在福建医科大学附属医院住院分娩的乙肝表面抗原(HBsAg)阳性孕妇。对照组为随机选取同期住院分娩的健康孕妇。
    结果:总体而言,1115名参与者被纳入并分组为对照组(n=380)和HBsAg阳性组(n=735),进一步分为I组(n=407;低病毒载量),II(n=207;无抗病毒治疗的高病毒载量),和III(n=121;抗病毒治疗的高病毒载量)。HBV孕妇与妊娠肝内胆汁淤积症(ICP)的发生率呈正相关(调整比值比[aOR]5.1,95%置信区间[CI]2.62-9.92,P<0.001),新生儿黄疸(aOR10.56,95%CI4.49-24.83,P<0.001),和新生儿窒息(aOR5.03,95%CI1.46-17.27,P=0.01)。天冬氨酸转氨酶(AST)高于正常值上限(ULN)是ICP发生率升高的独立危险因素(aOR3.49,95%CI1.26~9.67,P=0.019)。抗病毒治疗显着降低HBVDNA和改善肝功能。高病毒载量和抗病毒治疗与不良妊娠结局无显著相关性(P<0.05)。
    结论:HBV孕妇的ICP发病率显著升高,新生儿黄疸,新生儿窒息与病毒载量无显著相关性。AST大于ULN独立地增加ICP的风险。抗病毒治疗可有效减少病毒复制并改善肝功能,而不会增加不良后果的风险。
    OBJECTIVE: To explore the relationships between gestational hepatitis B virus (HBV) infection, antiviral therapy, and pregnancy outcomes.
    METHODS: We retrospectively selected hepatitis B surface antigen (HBsAg)-positive pregnant women hospitalized for delivery at Fujian Medical University Affiliated Hospital from October 1, 2016 to October 1, 2020. The control group included randomly selected healthy pregnant women hospitalized for delivery during the same time.
    RESULTS: Overall, 1115 participants were enrolled and grouped into control (n = 380) and HBsAg-positive groups (n = 735), which were further divided into groups I (n = 407; low viral load), II (n = 207; high viral load without antiviral therapy), and III (n = 121; high viral load with antiviral therapy). Pregnant women with HBV were positively correlated with the incidence of intrahepatic cholestasis of pregnancy (ICP) (adjusted odds ratio [aOR] 5.1, 95% confidence interval [CI] 2.62-9.92, P < 0.001), neonatal jaundice (aOR 10.56, 95% CI 4.49-24.83, P < 0.001), and neonatal asphyxia (aOR 5.03, 95% CI 1.46-17.27, P = 0.01). Aspartate aminotransferase (AST) greater than the upper limit of normal (ULN) was an independent risk factor for increased ICP incidence (aOR 3.49, 95% CI 1.26-9.67, P = 0.019). Antiviral therapy considerably reduced HBV DNA and improved liver function. High viral load and antiviral therapy did not correlate significantly with adverse pregnancy outcomes (P < 0.05).
    CONCLUSIONS: Pregnant women with HBV have significantly elevated incidence of ICP, neonatal jaundice, and neonatal asphyxia not significantly correlated with viral load. AST greater than ULN independently increases the risk of ICP. Antiviral therapy effectively reduces viral replication and improves liver function without increasing the risk of adverse outcomes.
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  • 文章类型: Journal Article
    背景:新生儿黄疸是一种常见病,当严重病例未被发现时,可导致脑损伤和残疾。低收入和中等收入国家往往缺乏检测新生儿黄疸的准确方法,依靠视觉评估,导致不良后果的发生率较高。PicterusJaundicePro(PicterusJP),一种易于使用且价格合理的基于智能手机的疾病筛查设备,在挪威已经证明了比视觉评估更高的准确性,菲律宾和墨西哥新生儿。这项研究旨在通过探索新生儿黄疸检测的当前过程和利益相关者的观点,确定在墨西哥低收入环境中在公共卫生服务中实施PicterusJP的障碍和促进者。
    方法:定性数据收集技术,包括一个焦点小组,15次半结构化访谈和4次观察,受雇于瓦哈卡的城乡医疗机构,墨西哥。参与者包括医生,护士和卫生管理员。在执行研究综合框架的指导下,通过专题分析对数据进行了分析。
    结果:分析产生了四个主要主题:(I)新生儿护理和NNJ检测的现状,(二)加强NNJ检测的需求和愿望,(III)在卫生系统中实施PicterusJP的障碍和促进者,以及(IV)HCWs对PicterusJP的期望。研究结果发现了当前新生儿黄疸检测过程中的缺陷,以及参与者对更准确方法的渴望。PicterusJP被认为易于使用,有用且与工作例程兼容,但是发现了收养的障碍,包括互联网缺陷和成本。
    结论:引入PicterusJP作为筛查新生儿黄疸的支持工具是有希望的,但必须解决背景障碍才能成功实施。还有机会优化视觉评估以改善新生儿黄疸的检测。
    BACKGROUND: Neonatal jaundice is a common condition that can lead to brain damage and disabilities when severe cases go undetected. Low- and middle-income countries often lack accurate methods for detecting neonatal jaundice and rely on visual assessment, resulting in a higher incidence of adverse consequences. Picterus Jaundice Pro (Picterus JP), an easy-to-use and affordable smartphone-based screening device for the condition, has demonstrated higher accuracy than visual assessment in Norwegian, Philippine and Mexican newborns. This study aimed to identify the barriers and facilitators to implementing Picterus JP in public health services in low-income settings in Mexico by exploring the current process of neonatal jaundice detection and stakeholders\' perspectives in that context.
    METHODS: Qualitative data collection techniques, including one focus group, 15 semi-structured interviews and four observations, were employed in urban and rural health facilities in Oaxaca, Mexico. The participants included medical doctors, nurses and health administrators. The data were analysed by thematic analysis guided by the Consolidated Framework for Implementation Research.
    RESULTS: The analysis yielded four main themes: (I) the current state of neonatal care and NNJ detection, (II) the needs and desires for enhancing NNJ detection, (III) the barriers and facilitators to implementing Picterus JP in the health system and (IV) HCWs\' expectations of Picterus JP. The findings identify deficiencies in the current neonatal jaundice detection process and the participants\' desire for a more accurate method. Picterus JP was perceived as easy to use, useful and compatible with the work routine, but barriers to adoption were identified, including internet deficiencies and costs.
    CONCLUSIONS: The introduction of Picterus JP as a supporting tool to screen for neonatal jaundice is promising but contextual barriers in the setting must be addressed for successful implementation. There is also an opportunity to optimise visual assessment to improve detection of neonatal jaundice.
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  • 文章类型: Journal Article
    背景:美国儿科学会和加拿大儿科协会都建议所有新生儿在出院前应进行胆红素筛查,这已经成为两国的标准做法。然而,美国预防工作组没有发现强有力的证据表明,这种胆红素普遍筛查的做法可减少胆红素诱发的神经功能障碍或脑白质黄疸等重要结局的发生.
    目的:评估经皮筛查与目测检查高胆红素血症的有效性,以防止新生儿(妊娠超过35周的婴儿)再次接受光疗。
    方法:我们搜索了CENTRAL,MEDLINE,Embase,CINAHL,ClinicalTrials.gov,ICTRP,和ISRCTN在2023年6月。我们还搜查了会议记录,以及纳入研究的参考清单。
    方法:我们纳入了随机对照试验(RCT),准随机化,集群随机化,或与对照组进行前瞻性队列研究,以评估出院前新生儿经皮胆红素(TcB)筛查高胆红素血症的使用。
    方法:我们使用了Cochrane预期的标准方法学程序。我们使用具有风险比(RR)和95%置信区间(CI)的分类数据和平均值的固定效应模型评估治疗效果。标准偏差(SD),和连续数据的平均差(MD)。我们使用等级方法来评估证据的确定性。
    结果:我们确定了一个符合纳入标准的RCT(1858名参与者)。该研究包括1858名非洲新生儿,他们在妊娠35周或以上,在婴儿托儿所接受常规护理,并在出院前随机招募接受TcB筛查。该研究具有良好的方法学质量。新生儿高胆红素血症的TcB筛查与视觉评估:-可能会降低高胆红素血症的再入院率(RR0.25,95%CI0.14至0.46;P<0.0001;中度确定性证据);-可能对交换输血率影响很小或没有影响(RR0.20,95%CI0.01至14.16;低确定性证据);-可能会增加需要接受光治疗的新生儿数量(中度RR至2.67%CI)。-可能对急性胆红素脑病的发生率影响很小或没有影响(RR0.33,95%CI0.01至8.18;低确定性证据)。该研究未评估或报告护理费用。
    结论:中度确定性证据表明,与目视检查相比,TcB筛查可降低高胆红素血症的再入院率。低确定性证据还表明,与目视检查相比,TcB筛查可能对交换输血率影响很小或没有影响。然而,中度确定性证据表明,与目视检查相比,TcB筛查可能会增加出院前需要光疗的新生儿数量.低确定性证据表明,与目视检查相比,TcB筛查可能对急性胆红素脑病的发生率影响很小或没有影响。鉴于我们只确定了一个RCT,需要进一步的研究来确定TcB筛查是否有助于减少新生儿高胆红素血症的再入院和并发症.在新生儿出院后随访有限的情况下,在出院前确定有严重高胆红素血症风险的新生儿对于计划这些婴儿的针对性随访非常重要.
    The American Academy of Pediatrics and the Canadian Paediatric Society both advise that all newborns should undergo bilirubin screening before leaving the hospital, and this has become the standard practice in both countries. However, the US Preventive Task Force has found no strong evidence to suggest that this practice of universal screening for bilirubin reduces the occurrence of significant outcomes such as bilirubin-induced neurologic dysfunction or kernicterus.
    To evaluate the effectiveness of transcutaneous screening compared to visual inspection for hyperbilirubinemia to prevent the readmission of newborns (infants greater than 35 weeks\' gestation) for phototherapy.
    We searched CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, ICTRP, and ISRCTN in June 2023. We also searched conference proceedings, and the reference lists of included studies.
    We included randomized controlled trials (RCTs), quasi-randomized, cluster-randomized, or prospective cohort studies with control arm that evaluated the use of transcutaneous bilirubin (TcB) screening for hyperbilirubinemia in newborns before hospital discharge.
    We used standard methodologic procedures expected by Cochrane. We evaluated treatment effects using a fixed-effect model with risk ratio (RR) and 95% confidence intervals (CI) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to evaluate the certainty of evidence.
    We identified one RCT that met our inclusion criteria. The study included 1858 African newborns at 35 weeks\' gestation or greater who were receiving routine care at a well-baby nursery, and were randomly recruited prior to discharge to undergo TcB screening. The study had good methodologic quality. TcB screening versus visual assessment of hyperbilirubinemia in newborns: - probably reduces readmission to the hospital for hyperbilirubinemia (RR 0.25, 95% CI 0.14 to 0.46; P < 0.0001; moderate-certainty evidence); - may have little or no effect on the rate of exchange transfusion (RR 0.20, 95% CI 0.01 to 14.16; low-certainty evidence); - probably increases the number of newborns who require phototherapy prior to discharge (RR 2.67, 95% CI 1.56 to 4.55; moderate-certainty evidence). - may have little or no effect on the rate of acute bilirubin encephalopathy (RR 0.33, 95% CI 0.01 to 8.18; low-certainty evidence). The study did not evaluate or report cost of care.
    Moderate-certainty evidence suggests that TcB screening probably reduces hospital readmission for hyperbilirubinemia compared to visual inspection. Low-certainty evidence also suggests that TcB screening may have little or no effect on the rate of exchange transfusion compared to visual inspection. However, moderate-certainty evidence suggests that TcB screening probably increases the number of newborns that require phototherapy before discharge compared to visual inspection. Low-certainty evidence suggests that TcB screening may have little or no effect on the rate of acute bilirubin encephalopathy compared to visual inspection. Given that we have only identified one RCT, further studies are necessary to determine whether TcB screening can help to reduce readmission and complications related to neonatal hyperbilirubinemia. In settings with limited newborn follow-up after hospital discharge, identifying newborns at risk of severe hyperbilirubinemia before hospital discharge will be important to plan targeted follow-up of these infants.
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  • 文章类型: Journal Article
    许多婴儿遇到的最常见问题之一是新生儿黄疸。症状是由于胆红素(血液中高于2.0至2.5mg/dL)导致皮肤或眼睛发黄。如果不及时治疗,会导致严重的神经系统并发症.传统上,黄疸检测依赖于侵入性血液检查,但是开发非侵入性生物传感器提供了一种替代方法。本系统综述旨在评估这些生物传感器的进步。这篇综述讨论了许多已知的用于检测新生儿黄疸的侵入性和非侵入性诊断方式及其局限性。报告还指出,用于新生儿黄疸诊断的无创生物传感器的最新研究和开发仍处于早期阶段,大多数研究是在体外或临床前水平。非侵入性生物传感器可以彻底改变新生儿黄疸检测;然而,在这种情况发生之前,仍然需要解决许多问题。这些包括深入的验证研究,经济实惠和用户友好的小工具,和监管机构的批准。为了创建符合监管要求的生物传感器,需要更多的研究来使它们更加精确和负担得起。
    One of the most common problems many babies encounter is neonatal jaundice. The symptoms are yellowing of the skin or eyes because of bilirubin (from above 2.0 to 2.5 mg/dL in the blood). If left untreated, it can lead to serious neurological complications. Traditionally, jaundice detection has relied on invasive blood tests, but developing non-invasive biosensors has provided an alternative approach. This systematic review aims to assess the advancement of these biosensors. This review discusses the many known invasive and non-invasive diagnostic modalities for detecting neonatal jaundice and their limitations. It also notes that the recent research and development on non-invasive biosensors for neonatal jaundice diagnosis is still in its early stages, with the majority of investigations being in vitro or at the pre-clinical level. Non-invasive biosensors could revolutionize neonatal jaundice detection; however, a number of issues still need to be solved before this can happen. These consist of in-depth validation studies, affordable and user-friendly gadgets, and regulatory authority approval. To create biosensors that meet regulatory requirements, additional research is required to make them more precise and affordable.
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  • 文章类型: Journal Article
    光疗(PT)是一种广泛使用的治疗新生儿黄疸,然而,理想的应用模式仍然存在争议。在这项研究中,比较了连续性光疗(CPT)和间歇性光疗(IPT)治疗新生儿间接高胆红素血症(IHB)的效果,并研究了IPT是否是一种较好的治疗方式.单中心平行随机对照开放标签试验。使用基于计算机的随机数表来分配治疗。纳入2022年7月至2023年4月期间在我们的新生儿重症监护病房(NICU)接受光疗的妊娠≥34周的新生儿。CPT连续应用6h,IPT在6小时的时间内作为1小时开启和2小时关闭的2个周期应用。两组在光疗停止后8小时测量回弹TSB。光疗持续时间,比较干预组的TSB降低率和反弹胆红素率。在研究期间,一名饥饿和四名新生儿符合纳入标准。CPT和IPT分别用于52例新生儿。研究组的人口统计学特征,包括性,交货方式,出生体重,入院体重,出生后的年龄,饮食,卸料重量,和兄弟姐妹的PT历史,结果相似(p>0.05)。两组中IHB的最常见原因是ABO不相容性。CPT组的中位光疗时间为12h(6-15),IPT组为4h(2-4)(p<0.001)。接受IPT的患者的平均胆红素下降率为1.12±0.73mg/dl/h,接受CPT的患者的平均胆红素下降率为0.51±0.33mg/dl/h(p<0.001)。CPT组光疗后8h胆红素反弹率平均值为0.08±0.28mg/dl/h,IPT组为-0.01±0.17mg/dl/h(p=0.039)。CPT组的住院时间更长(p=0.032)。皮疹,IPT组腹泻和体温升高的发生率较低(p<0.001).
    结论:在这项研究中,发现IPT在降低总血清胆红素方面至少与CPT一样有效。即使在IPT中PT的持续时间较短,胆红素反弹速度较慢,住院时间较短,副作用发生率较低,表明间歇性光疗优于连续性光疗.选择IPT而不是CPT是新生儿黄疸更合理的方法。
    结果:gov标识符:NCT06386731(回顾性注册于23/04/2024)已知:•PT通常用于新生儿黄疸的治疗。•PT没有标准的应用模型。
    背景:•IPT模型与CPT一样有效。•新生儿使用IPT更快地排出。
    Phototherapy (PT) is a widely used treatment for neonatal jaundice, yet the ideal model of application remains controversial. In this study, the effects of continuous phototherapy (CPT) and intermittent phototherapy (IPT) models were compared in the treatment of neonatal indirect hyperbilirubinemia (IHB) and whether IPT is a superior modality is investigated. Single-centre parallel randomized controlled open label trial. A computer-based table of random numbers was used to allocate treatments. Newborns ≥ 34 weeks\' gestation who received phototherapy in our neonatal intensive care unit (NICU) between July 2022 and April 2023 were included. CPT was applied continuously for 6 h, and IPT was applied as 2 cycles of 1 h on and 2 h off in a 6-h session. Rebound TSB was measured 8 h after phototherapy was stopped in both groups. Phototherapy duration, TSB reduction rate and rebound bilirubin rate were compared between intervention groups. One hundered and four neonates met the inclusion criteria during the study period. CPT and IPT were each used in 52 newborns. Demographic characteristics of the study groups, including sex, mode of delivery, birth weight, admission weight, age at postnatal presentation, diet, discharge weight, and history of PT in siblings, were similar (p > 0.05). The most common cause of IHB in both groups was ABO incompatibility. The median phototherapy time was 12 h (6-15) in the CPT group and 4 h (2-4) in the IPT group (p < 0.001). The mean rate of bilirubin decrease was 1.12 ± 0.73 mg/dl/h in those who underwent IPT and 0.51 ± 0.33 mg/dl/h in those who underwent CPT (p < 0.001). The mean rebound bilirubin rate 8 h after phototherapy was 0.08 ± 0.28 mg/dl/h in the CPT group, and -0.01 ± 0.17 mg/dl/h in the IPT group (p = 0.039). The length of hospital stay was longer in the CPT group (p = 0.032). Skin rash, diarrhoea and increased body temperature were less frequent in the IPT group (p < 0.001).
    CONCLUSIONS: In this study, IPT was found to be at least as effective as CPT in reducing total serum bilirubin. Even though the duration of PT is shorter in IPT, the slower rate of rebound bilirubin, shorter hospital stays and lower incidence of side effects indicated that intermittent phototherapy is superior to continuous phototherapy. Choosing IPT over CPT is a more rational approach in neonatal jaundice.
    RESULTS: gov Identifier: NCT06386731 (registered retrospectively on 23/04/2024) What is Known: • PT is common used in the treatment of neonatal jaundice. • There is no standard model of application for PT.
    BACKGROUND: • The IPT model is as effective as CPT. • Newborns are discharged faster with IPT.
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  • 文章类型: Journal Article
    Objective: To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice. Methods: Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate\'s parents used the JCard to measure jaundice at the neonate\'s cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson\'s correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis. Results: Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation (r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0 μmol/L. The TcB value of 205.2 μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusions: JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).
    目的: 评估父母使用黄疸比色卡(JCard)辅助目测识别新生儿高胆红素血症的准确性、诊断效能及应用价值。 方法: 以诊断准确性研究报告标准(STARD)为指导,2019年10月至2021年9月在国内9家医院进行多中心前瞻性研究。纳入854例住院或门诊就诊因自身疾病需检测肝功能的出生胎龄≥35周、出生体重≥2 000 g、年龄≤28日龄的新生儿。新生儿的父母使用JCard测量新生儿脸颊处的胆红素水平。在JCard测量后2 h内,研究人员使用JH20-1B黄疸仪测量胸骨处经皮胆红素(TcB)水平并采静脉血检测血清总胆红素水平。采用Pearson分析进行相关性分析,Bland-Altman法分析一致性,受试者工作特征(ROC)曲线分析JCard的诊断效能。 结果: 854例新生儿中男445例、女409例;出生胎龄35~36周46例,≥37周808例;检测时年龄0~3日龄432例,4~7日龄236例,8~28日龄186例;总胆红素值为(227.4±89.6)μmol/L,范围23.7~717.0 μmol/L;JCard值为(221.4±77.0)μmol/L,TcB值为(252.5±76.0)μmol/L。JCard和TcB值均与总胆红素有较好的相关性(r=0.77、0.80)和较强的一致性[分别有96.0%(820/854)和95.2%(813/854)的样本落在95%一致性界限内]。诊断效能分析显示,JCard值12识别总胆红素界值205.2 μmol/L的灵敏度为0.93、特异度为0.75,识别总胆红素界值342.0 μmol/L的灵敏度为1.00、特异度为0.35。TcB值205.2 μmol/L识别总胆红素界值205.2 μmol/L的灵敏度为0.97、特异度为0.60,识别总胆红素界值342.0 μmol/L的灵敏度为1.00、特异度为0.26。JCard识别总胆红素界值153.9、205.2、256.5和342.0 μmol/L的ROC曲线下面积(AUC)分别为0.96、0.92、0.83和0.83,TcB分别为0.94、0.91、0.86和0.87。当识别总胆红素界值153.9和205.2 μmol/L时,JCard的AUC与TcB差异均无统计学意义(均P>0.05);当识别总胆红素界值256.5和342.0 μmol/L时,JCard的AUC均低于TcB(均P<0.05)。 结论: JCard可以帮助父母判断新生儿高胆红素血症的程度,但诊断效能随着胆红素水平的升高而降低。当总胆红素≤205.2 μmol/L时,JCard的诊断效能与JH20-1B黄疸仪相当。为了避免重度高胆红素血症的漏诊,建议使用JCard值12筛查重度高胆红素血症(总胆红素≥342.0 μmol/L)。.
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