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

NCT ID: NCT01178905

Last Updated: 2013-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infection Preterm Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Study Groups

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Mother CMV positive

Group Type OTHER

ultrashort heat inactivation

Intervention Type PROCEDURE

Interventions

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ultrashort heat inactivation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* parents disagree
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Principal Investigators

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Rangamr Goelz, MD

Role: PRINCIPAL_INVESTIGATOR

Tuebingen University Hospital

Locations

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Tuebingen University Hospital

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30407512 (View on PubMed)

Other Identifiers

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BM CMV inactivation

Identifier Type: -

Identifier Source: org_study_id

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