Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms - Full Text View

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00668798

Purpose

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

Condition
Cytomegalovirus

MedlinePlus related topics: Cytomegalovirus Infections

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Incidence and Clinical Outcome of Human Cytomegalovirus Transmission Via Thawed Frozen Breast Milk in Preterm Infants <31 Weeks. A Prospective Trial.

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

CMV status of preterm infants [ Time Frame: 2005-2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical manifestations of CMV infection [ Time Frame: 2005-2008 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

thawed frozen breast milk of lactating mothers

Enrollment:	58
Study Start Date:	January 2005
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
A mother CMV positive
B mother CMV negative

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	24 Weeks to 31 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

preterm infants of less than 32 weeks of gestation

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668798

Locations

Germany
Childrens Hospital Goethe University
Frankfurt, Germany, 60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Karl Bauer, Professor

Goethe University, Dpt of Neonatology

More Information

Publications:

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.

Responsible Party:	Goethe University, Frankfurt ( Prof Karl Bauer, Head of Dpt. of Neonatology )
Study ID Numbers:	CMV/MM0105/FFM
Study First Received:	April 25, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00668798
Health Authority:	Germany: Federal Office for Consumer's Safety and Veterinarian Medicine

Keywords provided by Johann Wolfgang Goethe University Hospitals:

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

Study placed in the following topic categories:

Virus Diseases
Cytomegalovirus Infections
DNA Virus Infections

Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009