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Biochip for HCMV Detection in Breast Milk

NCT02840825 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2022-07-28

No results posted yet for this study

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Gérard Thiriez, MD, PhD · Centre hospitalier régional universitaire de Besançon

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2021-09-29
Completion
2021-09-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840825 on ClinicalTrials.gov