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

Not Applicable

Completed

• Conditions: Cytomegalovirus Infection; Preterm Infants
• Interventions: Procedure: ultrashort heat inactivation

• Registration Number: NCT01178905
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-26
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• parents disagree

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mother CMV positive	ultrashort heat inactivation	-

Primary Outcome Measures

Name	Time	Method
Number of participants with CMV viruria	40 weeks gestational age, or at discharge from NICU (if this is earlier)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Tuebingen University Hospital; 🇩🇪 Tuebingen, Germany