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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01178905
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : April 24, 2013
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Preterm Infants Procedure: ultrashort heat inactivation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : August 2010
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Mother CMV positive Procedure: ultrashort heat inactivation

Primary Outcome Measures :
  1. Number of participants with CMV viruria [ Time Frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier) ]

Secondary Outcome Measures :
  1. 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) ]
    Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

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

Exclusion Criteria:

  • parents disagree

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01178905

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Tuebingen University Hospital
Tuebingen, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
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Principal Investigator: Rangamr Goelz, MD Tuebingen University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01178905     History of Changes
Other Study ID Numbers: BM CMV inactivation
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
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Communicable Diseases
Premature Birth
Cytomegalovirus Infections
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Herpesviridae Infections
DNA Virus Infections
Virus Diseases