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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

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ClinicalTrials.gov Identifier: NCT01178905
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : April 24, 2013
Sponsor:
Information provided by:
University Hospital Tuebingen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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

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


Outcome Measures
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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)


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

Inclusion Criteria:

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

Exclusion Criteria:

  • parents disagree
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 ClinicalTrials.gov identifier (NCT number): NCT01178905


Locations
Germany
Tuebingen University Hospital
Tuebingen, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Rangamr Goelz, MD Tuebingen University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov 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:
Infection
Communicable Diseases
Premature Birth
Cytomegalovirus Infections
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Herpesviridae Infections
DNA Virus Infections
Virus Diseases