Clinical trial NCT02840825: Biochip for HCMV Detection in Breast Milk
Official title: Biochip for HCMV Detection in Breast Milk From Lactating Women of Preterm Infants Less Than 33 Weeks
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cytomegalovirus Infections
Breast Feeding
Premature Birth of Newborn
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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."

Primary outcomes:
measure: optical detection of HCMV specifically captured on the biochip with respect to the reference (PCR) technique.
timeFrame: Within 4 days after receiving the breast milk sample
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
affiliation: Centre hospitalier régional universitaire de Besançon
name: Gérard Thiriez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: