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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
This study has been completed.
Sponsor:
University Hospital Tuebingen
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01178905
First received: July 26, 2010
Last updated: April 23, 2013
Last verified: February 2013
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Purpose
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) ]
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) ]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 |
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01178905
Please refer to this study by its ClinicalTrials.gov identifier: 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
| ClinicalTrials.gov Identifier: | NCT01178905 History of Changes |
| Other Study ID Numbers: |
BM CMV inactivation |
| Study First Received: | July 26, 2010 |
| Last Updated: | April 23, 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 |
ClinicalTrials.gov processed this record on June 23, 2017