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临床试验/NCT03262194
NCT03262194终止不适用

Relevance of Gastric Aspirate in HCMV Detection

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
1
主要终点
Match between gastral aspirate PCR results and urine PCR results

研究概览

简要总结

Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially premature infants. CMV infection can result from materno-fetal transmission during pregnancy (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5% of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing loss and other delayed neurological complications. A progressive neurosensory hearing loss may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing loss has a significant impact on the future life of the child, mainly on language acquisition and school performance.

A systematic CMV screening is not currently recommended at birth due to the frequency of asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for preventive and curative treatment of the infection. New treatments are being evaluated and encouraging results could revive the debate.

PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is not systematic in newborns and its realization can sometimes be difficult. On the other hand, in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory distress at birth), gastric aspiration is systematically performed at birth to overcome obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid inhalation by reflux and sometimes to make a bacteriological diagnosis.

Our hypothesis is that this liquid could be used for the detection of CMV infection without adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine CMV screening in children at risk and thus allow for appropriate care by nursing staff.The occurrence of immediate or delayed sensory sequelae in these children would be then limited.

研究设计

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

入排标准

年龄范围
1 Minute 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Match between gastral aspirate PCR results and urine PCR results

时间窗: day 7

Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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