Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants

April 23, 2013 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72070
        • Tuebingen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • parents disagree

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mother CMV positive
Procedure: ultrashort heat inactivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with CMV viruria
Time Frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)
40 weeks gestational age, or at discharge from NICU (if this is earlier)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
40 weeks of gestational age or at discharge from NICU (if this is earlier)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Rangamr Goelz, MD, Tuebingen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM CMV inactivation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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