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
|
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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 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 |

Arm | Intervention/treatment |
---|---|
Mother CMV positive | Procedure: ultrashort heat inactivation |
- Number of participants with CMV viruria [ Time Frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier) ]
- 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)

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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

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
Germany | |
Tuebingen University Hospital | |
Tuebingen, Germany, 72070 |
Principal Investigator: | Rangamr Goelz, MD | Tuebingen University Hospital |
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 |