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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

Primary Purpose

Cytomegalovirus Infection, Preterm Infants

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ultrashort heat inactivation
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

23 Weeks - 40 Weeks (Child)All Sexes

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

First Posted
July 26, 2010
Last Updated
April 23, 2013
Sponsor
University Hospital Tuebingen
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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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