Biochip for HCMV Detection in Breast Milk

NCT ID: NCT02840825

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2021-09-29

Brief 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.

Conditions

Cytomegalovirus Infections; Breast Feeding; Premature Birth of Newborn

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gérard Thiriez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier régional universitaire de Besançon

Locations

CHRU de Besançon

Besançon, , France

Countries

France

Other Identifiers

API/2015/63

Identifier Type: -

Identifier Source: org_study_id