Cytomegalovirus InfectionsVIRUMILKNCT02840825
Biochip for HCMV Detection in Breast Milk
An observational study of Cytomegalovirus Infections and Breast Feeding, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially preterm infants. HCMV infection may result from maternal-fetal transmission during pregnancy or postnatal transmission. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cytomegalovirus Infections, Breast Feeding, Premature Birth of Newborn
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2016to 29 Sep 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will be proposed to mothers meeting the criteria described in part "Eligibility criteria" during an investigators' visit of the newborn infant in the Department of Neonatal Medicine of the Besancon University Hospital. They will then receive information on the study. The practitioner responsible for the study will also collect non-opposition of mothers.
Who may be able to join
- Lactating women (> 18 years)
- Mothers with infants less than 33 weeks hospitalized in intensive care infant / neonatal the University Hospital of Besancon.
- No opposition mothers.
- Join a French social security or receiving such a scheme.
- Subjects who received medical care during pregnancy.
Who cannot join
- Legal incapacity or limited legal capacity.
- Topics without health insurance.
- Topics being in the disqualification of another study or under the "national register of volunteers."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biochip for HCMV Detection in Breast Milk From Lactating Women of Preterm Infants Less Than 33 Weeks
Human cytomegalovirus (HCMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially preterm infants. HCMV infection may result from maternal-fetal transmission during pregnancy or postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm infants, the risk of postnatal infection, particularly through breast milk, is much higher in this population (prevalence of about 20%). Many learned societies wonder about the interest to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or eliminate contamination of these children. However, freezing is relatively inefficient to reduce contamination and pasteurization drastically alters the nutritional quality of the milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is not currently recommended. An alternative approach could consist in detecting HCMV in breast milk to target at-risk situations. This detection can be performed by PCR but its cost and the time required to obtain the result prohibits its use for a mass detection. Currently, viral status of breast milk is not explored in practice and, depending on the health centers, breastfeeding is continued as such or milk is systematically inactivated.The main objective of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm newborns less than 33 weeks.
- Medical subject headings
- Cytomegalovirus Infections, Breast Feeding, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
optical detection of HCMV specifically captured on the biochip with respect to the reference (PCR) technique.
Measured: Within 4 days after receiving the breast milk sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start8 Mar 2016
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Why it stopped: Technical issues with microchip
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.
- 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
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérard Thiriez, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840825
- Sponsor's protocol ID
- API/2015/63
- Acronym
- VIRUMILK
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2016
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochip for HCMV Detection in Breast Milk From Lactating Women of Preterm Infants Less Than 33 Weeks
- ClinicalTrials.gov ID
- NCT02840825
- Acronym / sponsor ID
- VIRUMILK / API/2015/63
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technical issues with microchip
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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 (HCMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially preterm infants. HCMV infection may result from maternal-fetal transmission during pregnancy or postnatal transmission. While congenital HCMV infection affects about 2-5% of very preterm infants, the risk of postnatal infection, particularly through breast milk, is much higher in this population (prevalence of about 20%). Many learned societies wonder about the interest to inactivate HCMV (by freezing or pasteurization) in breast milk in order to reduce or eliminate contamination of these children. However, freezing is relatively inefficient to reduce contamination and pasteurization drastically alters the nutritional quality of the milk. Therefore, a systematic preventive treatment of breast milk for very preterm infants is not currently recommended. An alternative approach could consist in detecting HCMV in breast milk to target at-risk situations. This detection can be performed by PCR but its cost and the time required to obtain the result prohibits its use for a mass detection. Currently, viral status of breast milk is not explored in practice and, depending on the health centers, breastfeeding is continued as such or milk is systematically inactivated.The main objective of VIRUMILK is to study the feasibility of the CMV detection in breast milk from lactating mothers with a biochip.The ultimate goal is to prevent postnatal HCMV infection of preterm newborns less than 33 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be proposed to mothers meeting the criteria described in part "Eligibility criteria" during an investigators' visit of the newborn infant in the Department of Neonatal Medicine of the Besancon University Hospital. They will then receive information on the study. The practitioner responsible for the study will also collect non-opposition of mothers.
Key inclusion criteria (5 listed)
- Lactating women (> 18 years)
- Mothers with infants less than 33 weeks hospitalized in intensive care infant / neonatal the University Hospital of Besancon.
- No opposition mothers.
- Join a French social security or receiving such a scheme.
- Subjects who received medical care during pregnancy.
Key exclusion criteria (3 listed)
- Legal incapacity or limited legal capacity.
- Topics without health insurance.
- Topics being in the disqualification of another study or under the "national register of volunteers."
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
optical detection of HCMV specifically captured on the biochip with respect to the reference (PCR) technique.
Time frame: Within 4 days after receiving the breast milk sample
Results and safety
The study was stopped early (reason given: Technical issues with microchip). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Gérard Thiriez, 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 Breast Feeding, 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 5 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 28 Jul 2022. 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: Technical issues with microchip). 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?
optical detection of HCMV specifically captured on the biochip with respect to the reference (PCR) technique. (time frame: Within 4 days after receiving the breast milk sample). 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 28 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.