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临床试验/NCT04769661
NCT04769661Unknown不适用

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

Assiut University0 个研究点目标入组 50 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Incidence of retinopathy of prematurity

研究概览

简要总结

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.

详细描述

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.
  1. Laboratory assessment:

A- Routine assessment:

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
— 至 1 Hour(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • presence of major congenital anomaly Presence of life threatening conditions

结局指标

主要结局

Incidence of retinopathy of prematurity

时间窗: 1 year

Measure incidence of retinopathy of prematurity in preterm infants

Association of cord blood cytokines and perinatal factors and retinopathy of prematurity

时间窗: 1 year

Discover if association exists between cord blood cytokines and perinatal factors and the occurence of retinopathy of prematurity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rewaa Mohammed

Role of cord blood cytokines and perinatal factors in prediction of retinopathy of prematurity

Assiut University

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