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

This study has been completed.
Information provided by:
University Hospital Tuebingen Identifier:
First received: July 26, 2010
Last updated: April 23, 2013
Last verified: February 2013

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.

Condition Intervention
Cytomegalovirus Infection
Preterm Infants
Procedure: ultrashort heat inactivation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Number of participants with CMV viruria [ Time Frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with specific neonatal outcome parameters as a measure of neonatal quality [ Time Frame: 40 weeks of gestational age or at discharge from NICU (if this is earlier) ] [ Designated as safety issue: Yes ]
    Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)

Study Start Date: August 2010
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mother CMV positive Procedure: ultrashort heat inactivation


Ages Eligible for Study:   23 Weeks to 40 Weeks
Genders Eligible for Study:   Both

Inclusion Criteria:

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

Exclusion Criteria:

  • parents disagree
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Please refer to this study by its identifier: NCT01178905

Tuebingen University Hospital
Tuebingen, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Rangamr Goelz, MD Tuebingen University Hospital
  More Information Identifier: NCT01178905     History of Changes
Other Study ID Numbers: BM CMV inactivation 
Study First Received: July 26, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Ministery of Science, Baden Wuerttemberg
Faculty of the Tuebingen University Hospital: Tuebingen

Keywords provided by University Hospital Tuebingen:
Postnatal CMV infection of preterm infants
breast milk

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Premature Birth
DNA Virus Infections
Herpesviridae Infections
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Virus Diseases processed this record on May 24, 2016