NCT02840825: VIRUMILK

Biochip for HCMV Detection in Breast Milk

Terminated Last updated 28 July 2022

What this trial tests

trial in Cytomegalovirus Infections in 2 participants. Terminated before completion.

Timeline

8 March 2016

Primary endpoint
29 September 2021

29 September 2021

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	2
Start date	8 March 2016
Primary completion	29 September 2021
Estimated completion	29 September 2021
Sites	1 location across France

Conditions studied

• Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →
• Breast Feeding — all drugs for Breast Feeding →
• Premature Birth of Newborn — all drugs for Premature Birth of Newborn →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, female only, with Cytomegalovirus Infections or Breast Feeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.