Relevance of Gastric Aspirate in HCMV Detection (VIRULAG)

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.

Study Overview

• Status: Terminated
• Conditions: Cytomegalovirus Infections; Hypotrophic Newborns

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

• Study Contact: Name: Stephanie Py, PhD; Phone Number: 0033 3 81 21 89 99; Email: s1py@chu-besancon.fr

Study Locations

• France
  • Besancon, France, 25000
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 week (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hypotrophic newborns

Description

Inclusion Criteria of the newborn:

- Child born in maternity and / or child hospitalized in the Neonatal Médicine Department of the University Hospital of Besançon for which a urine sample (minimum volume = 0.5 mL) and a gastric aspiration fluid sample (minimum volume = 0.7mL) were collected (regardless of gender, birth weight or pathology presented at admission).

Exclusion Criteria of the newborn:

• Child died before the sampling
• A volume of gastric aspiration fluid dedicated to the study less than 0.7 mL.
• An impossible collection of urine (malformation, skin irritation of the perineum, contamination with meconium).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Match between gastral aspirate PCR results and urine PCR results	Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results	day 7

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Thiriez Gérard, MD PhD, Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: P/2017/314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No