Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
Primary Purpose
Cytomegalovirus Infection, Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ultrashort heat inactivation
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Postnatal CMV infection of preterm infants, breast milk
Eligibility Criteria
Inclusion Criteria:
- <32 Weeks or GA or <1500g BW
- mother CMV IgG positive
- breast milk feeding
Exclusion Criteria:
- parents disagree
Sites / Locations
- Tuebingen University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mother CMV positive
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with CMV viruria
Secondary Outcome Measures
Number of participants with specific neonatal outcome parameters as a measure of neonatal quality
Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)
Full Information
NCT ID
NCT01178905
First Posted
July 26, 2010
Last Updated
April 23, 2013
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT01178905
Brief Title
Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection, Preterm Infants
Keywords
Postnatal CMV infection of preterm infants, breast milk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
Mother CMV positive
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
ultrashort heat inactivation
Primary Outcome Measure Information:
Title
Number of participants with CMV viruria
Time Frame
40 weeks gestational age, or at discharge from NICU (if this is earlier)
Secondary Outcome Measure Information:
Title
Number of participants with specific neonatal outcome parameters as a measure of neonatal quality
Description
Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)
Time Frame
40 weeks of gestational age or at discharge from NICU (if this is earlier)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
40 Weeks
Eligibility Criteria
Inclusion Criteria:
<32 Weeks or GA or <1500g BW
mother CMV IgG positive
breast milk feeding
Exclusion Criteria:
parents disagree
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rangamr Goelz, MD
Organizational Affiliation
Tuebingen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuebingen University Hospital
City
Tuebingen
ZIP/Postal Code
72070
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30407512
Citation
Bapistella S, Hamprecht K, Thomas W, Speer CP, Dietz K, Maschmann J, Poets CF, Goelz R. Short-term Pasteurization of Breast Milk to Prevent Postnatal Cytomegalovirus Transmission in Very Preterm Infants. Clin Infect Dis. 2019 Jul 18;69(3):438-444. doi: 10.1093/cid/ciy945.
Results Reference
derived
Learn more about this trial
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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