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

University Hospital Tuebingen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Conditions

Cytomegalovirus Infection Preterm Infants

Interventions

ultrashort heat inactivationPROCEDURE

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * \<32 Weeks or GA or \<1500g BW * mother CMV IgG positive * breast milk feeding Exclusion Criteria: * parents disagree

Locations (1)

Tuebingen University Hospital

Tübingen, Germany

Outcomes

Primary Outcomes

Number of participants with CMV viruria

Time frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)

Secondary Outcomes

Number of participants with specific neonatal outcome parameters as a measure of neonatal quality

Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)

Time frame: 40 weeks of gestational age or at discharge from NICU (if this is earlier)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.