NCT01178905

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

Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 23 Weeks – 40 Weeks
• Healthy volunteers: —

Summary

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.

Conditions

• Cytomegalovirus Infection
• Preterm Infants

Interventions

Type	Name	Description
PROCEDURE	ultrashort heat inactivation

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-10-01
• First posted: 2010-08-10
• Last updated: 2013-04-24

Locations

1 site across 1 country: Germany