Biochip for HCMV Detection in Breast Milk

NCT02840825 | Terminated

• 1 other identifier: API/2015/63
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHRU de Besançon

Besançon, 25000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

breastmilk

MeSH Terms

Conditions

Cytomegalovirus Infections; Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gérard Thiriez, MD, PhD

  Centre hospitalier régional universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: March 8, 2016
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

FR (1)