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Role of Cord Blood Cytokines and Perinatal Factors in Prediction of Retinopathy of Prematurity

2021年2月22日 更新者:Rewaa Mohammed、Assiut University
Cord blood will be taken after birth for evaluation of cytokines level. At age of 4-6 weeks, we will do fundus examination for babies . Retrograde, we will study the perinatal risk factors in subjects found to have retinopathy. Follow up fundus will be done according to results of the first examination. By this study,we will be able later on to predict whom of preterm infants are more prone to develop retinopathy of prematurity.

研究概览

地位

未知

详细说明

All patients will be subjected to the following:

  1. Clinical evaluation:

    • History taking including name, sex and age at diagnosis of ROP.
    • Detailed obstetric history [maternal age, type of conception (natural, hormonal or in vitro fertilization), type of delivery (vaginal or cesarean section), single or multiple gestation, pregnancy complications (hypertension, diabetes mellitus, placental abruption, premature rupture of membranes, chorioamnionitis), drug history including steroid treatment received prior to delivery].
    • Neonatal data [Gestational age by weeks calculated from the last menstrual period and confirmed by physical examination, birth weight in grams, Apgar scores at 1 and 5 minutes, weight appropriate or small for gestational age, presence of hypoxia during or after delivery, need for oxygen therapy (mode of delivery, duration, oxygen saturation), presence of clinical sepsis, Respiratory distress syndrome, anemia or the need of blood transfusion].
    • Complete physical examination will be done to all babies including cardiac, chest, abdominal and neurological examination.
  2. Laboratory assessment:

A- Routine assessment:

  1. Complete blood count (CBC) for the mother.
  2. CBC for all infants.

B- Immunological assessment: level of Interleukin-6 and 8, and Tumor necrosis factor-α will be assessed:

Umbilical cord blood will be sampled by venipuncture of umbilical vein at birth under complete aseptic conditions for determination of cytokine level. Cord blood samples will be collected on serum separator tube with gel and then are allowed to clot for 30 minutes at room temperature before centrifugation for 15 minutes at 1000xg. Serum will be removed and stored at ≤ -20 ˚c.till assessment by Lab-scan 3D using Luminex assay multiplex kits

3- Fundus examination After training on fundus examination at ophthalmology department, I will do it for babies. Current guidelines by the American Academy of Ophthalmology and Pediatrics, and American Association for Pediatric Ophthalmology and Strabismus recommend that all infants with gestational age ≤32 weeks or birth weight ≤1500g should be screened for retinopathy of prematurity (ROP). Unnecessary examinations may increase the medical costs for ROP screening. First examination will be done at age of 4 to 6 weeks of age, then every 2-3 weeks until their vessels have grown out to the ora serrate and the retina is considered mature. If ROP is diagnosed, examination will be done every 1-2 weeks according to the severity of the disease. The stage of ROP is the highest stage during all fundus examinations done.

研究类型

观察性的

注册 (预期的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 1小时 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Preterm babies with the previous eligible criteria who were delivered in Women's health hospital and admitted to neonatal intensive care unit of assiut pediatric hospital

描述

Inclusion Criteria:

  • gestational age less than 32 weeks Birth weight less than 1.5kg

Exclusion Criteria:

  • presence of major congenital anomaly Presence of life threatening conditions

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of retinopathy of prematurity
大体时间:1 year
Measure incidence of retinopathy of prematurity in preterm infants
1 year
Association of cord blood cytokines and perinatal factors and retinopathy of prematurity
大体时间:1 year
Discover if association exists between cord blood cytokines and perinatal factors and the occurence of retinopathy of prematurity
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:yasser farouk, lecturer、Assiut university children hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 1. Zin A, Gole GA. Retinopathy of prematurity-incidence today. Clin Perinatol. 2013;40:185-200. PMID: 23719304 DOI: 10.1016/j.clp.2013.02.001 2. Blencowe H, Lawn JE, Vazquez T, Fielder A, Gilbert C. Preterm-associated visual impairment and estimates of retinopathy of prematurity at regional and global levels for 2010. Pediatr Res. 2013;74(Suppl 1):35-49. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):17-34. doi: 10.1038/pr.2013.204.PMID: 24366461 3. Austeng D, Kallen KB, Ewald UW, Jakobsson PG, Holmstrom GE. Incidence of retinopathy of prematurity in infants born before 27 weeks' gestation in Sweden. Arch Ophthalmol. 2009;127:1315-9. PMID: 19822848 DOI: 10.1001/archophthalmol.2009.244 4. Lynch AM, Wagner BD, Hodges JK, et al. The relationship of the subtypes of preterm birth with retinopathy of prematurity. Am J Obstet Gynecol. 2017;217:354. 9. PMID: 28545834 DOI: 10.1016/j.ajog.2017.05.029

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年5月1日

初级完成 (预期的)

2022年5月30日

研究完成 (预期的)

2022年12月30日

研究注册日期

首次提交

2021年2月22日

首先提交符合 QC 标准的

2021年2月22日

首次发布 (实际的)

2021年2月24日

研究记录更新

最后更新发布 (实际的)

2021年2月24日

上次提交的符合 QC 标准的更新

2021年2月22日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

There is a plan to make individual participant data (IPD) and related data dictionaries available

IPD 共享时间框架

1 year

IPD 共享访问标准

Through finding the research on clinical trials.gov

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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