Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

NCT ID: NCT00668798

Last Updated: 2008-04-29

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

SUSPENDED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-03-31

Brief Summary

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Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission

Detailed Description

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Preterm infants are at risk of symptomatic human cytomegalovirus infections transmitted by breast milk. This study evaluates incidence, timing, and clinical rlevance of acquired human CMV infections in preterm infants younger than 32 weeks of gestational age receiving maternal thawed frozen breast milk until 33 completed weeks of gestational age.

Conditions

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Cytomegalovirus

Keywords

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cytomegalovirus breast milk preterm infants transmission transmission of CMV via thawed frozen breast milk

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

mother CMV positive

No interventions assigned to this group

B

mother CMV negative

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* preterm infants of less than 32 weeks of gestation

Exclusion Criteria

* preterm infant of 32 weeks of gestational age or older, feeding with solely formula milk
* ourborn infants
* retroviral infection
* CMV status of mother unclear
* informed consent missing
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

31 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Goethe University, Frankfurt

Principal Investigators

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Karl Bauer, Professor

Role: PRINCIPAL_INVESTIGATOR

Goethe University, Dpt of Neonatology

Locations

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Childrens Hospital Goethe University

Frankfurt, , Germany

Site Status

Countries

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Germany

References

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Hamprecht K, Maschmann J, Vochem M, Dietz K, Speer CP, Jahn G. Epidemiology of transmission of cytomegalovirus from mother to preterm infant by breastfeeding. Lancet. 2001 Feb 17;357(9255):513-8. doi: 10.1016/S0140-6736(00)04043-5.

Reference Type BACKGROUND
PMID: 11229670 (View on PubMed)

Other Identifiers

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CMV/MM0105/FFM

Identifier Type: -

Identifier Source: org_study_id