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Trial record 37 of 46 for:    congenital CMV

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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date August 23, 2017
First Posted Date August 25, 2017
Last Update Posted Date April 10, 2018
Actual Study Start Date September 19, 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2017)
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
Original Primary Outcome Measures
 (submitted: August 23, 2017)
Match between gastral aspirate PCR results and urine PCR results [ Time Frame: day 7 ]
Change History Complete list of historical versions of study NCT03262194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relevance of Gastric Aspirate in HCMV Detection
Official Title Relevance of Gastric Aspirate in HCMV Detection
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hypotrophic newborns
Condition
  • Cytomegalovirus Infections
  • Hypotrophic Newborns
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 23, 2017)
115
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages up to 7 Days   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Stephanie Py, PhD 0033 3 81 21 89 99 s1py@chu-besancon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03262194
Other Study ID Numbers P/2017/314
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators Not Provided
Investigators
Principal Investigator: Thiriez Gérard, MD PhD Centre Hospitalier Universitaire de Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date April 2018