Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants

University Hospital Tuebingen

Status: Completed

Conditions: Preterm Infants; Cytomegalovirus Infection

Treatments: Procedure: ultrashort heat inactivation

Study type: Interventional

Funder types: Other

Identifiers

NCT01178905

BM CMV inactivation

Details and patient eligibility

About

To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.

The protocol has been approved by the ethics committee of Tuebingen University Hospital.

Sex: All

Ages: 23 to 40 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <32 Weeks or GA or <1500g BW
• mother CMV IgG positive
• breast milk feeding

Exclusion criteria

• parents disagree

Trial design

0 participants in 1 patient group

Mother CMV positive

Other group

Treatment:

Procedure: ultrashort heat inactivation