Cytomegalovirus Infection, Preterm Infants
Conditions
Keywords
Postnatal CMV infection of preterm infants, breast milk
Brief 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.
Interventions
PROCEDUREultrashort heat inactivation
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 40 Weeks
Inclusion criteria
* \<32 Weeks or GA or \<1500g BW * mother CMV IgG positive * breast milk feeding
Exclusion criteria
* parents disagree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with CMV viruria | 40 weeks gestational age, or at discharge from NICU (if this is earlier) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with specific neonatal outcome parameters as a measure of neonatal quality | 40 weeks of gestational age or at discharge from NICU (if this is earlier) | Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP) |
Countries
Germany
Outcome results
None listed