Biochip for HCMV Detection in Breast Milk

Cytomegalovirus Infections Clinical Trial

— VIRUMILK  

Official title:

Biochip for HCMV Detection in Breast Milk From Lactating Women of Preterm Infants Less Than 33 Weeks

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02840825
• Other study ID #: API/2015/63
• Status: Terminated
• Start date: March 8, 2016
• Est. completion date: September 29, 2021

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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."

Related Conditions & MeSH terms

• Breast Feeding
• Cytomegalovirus Infections
• Premature Birth
• Premature Birth of Newborn

Locations

Country	Name	City	State
France	CHRU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optical detection of HCMV specifically captured on the biochip with respect to the reference (PCR) technique.		Within 4 days after receiving the breast milk sample