Relevance of Gastric Aspirate in HCMV Detection (VIRULAG)
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|ClinicalTrials.gov Identifier: NCT03262194|
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : April 10, 2018
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.
|Condition or disease|
|Cytomegalovirus Infections Hypotrophic Newborns|
|Study Type :||Observational|
|Estimated Enrollment :||115 participants|
|Official Title:||Relevance of Gastric Aspirate in HCMV Detection|
|Actual Study Start Date :||September 19, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||July 2019|
- Match between gastral aspirate PCR results and urine PCR results [ Time Frame: day 7 ]Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262194
|Contact: Stephanie Py, PhD||0033 3 81 21 89 firstname.lastname@example.org|
|Besancon, France, 25000|
|Contact: Gérard Thiriez, PU/PH 0381218269 email@example.com|
|Principal Investigator:||Thiriez Gérard, MD PhD||Centre Hospitalier Universitaire de Besançon|