Cytomegalovirus InfectionsVIRULAGNCT03262194
Relevance of Gastric Aspirate in HCMV Detection
An observational study of Cytomegalovirus Infections and Hypotrophic Newborns, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Cytomegalovirus Infections, Hypotrophic Newborns
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2017to 7 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Hypotrophic newborns
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cytomegalovirus Infections, Hypotrophic Newborns
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Match between gastral aspirate PCR results and urine PCR results
Match between gastral aspirate polymerase chain reaction results and urine polymerase chain reaction results
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start19 Sep 2017
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Why it stopped: The introduction of new recommendations for early neonatal infection has drastically reduced the need for gastric aspiration at birth.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thiriez Gérard, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262194
- Sponsor's protocol ID
- P/2017/314
- Acronym
- VIRULAG
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2017
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Gastric Aspirate in HCMV Detection
- ClinicalTrials.gov ID
- NCT03262194
- Acronym / sponsor ID
- VIRULAG / P/2017/314
- Conditions
- Cytomegalovirus Infections, Hypotrophic Newborns
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The introduction of new recommendations for early neonatal infection has drastically reduced the need for gastric aspiration at birth.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hypotrophic newborns
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: The introduction of new recommendations for early neonatal infection has drastically reduced the need for gastric aspiration at birth.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiriez Gérard, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Hypotrophic Newborns, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The introduction of new recommendations for early neonatal infection has drastically reduced the need for gastric aspiration at birth.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Match between gastral aspirate PCR results and urine PCR results (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.