Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

This study has suspended participant recruitment.
Information provided by:
Johann Wolfgang Goethe University Hospitals Identifier:
First received: April 25, 2008
Last updated: April 28, 2008
Last verified: April 2008
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission


Study Type: Observational
Study Design: Time Perspective: 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
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)
mother CMV positive
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.

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

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
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Please refer to this study by its identifier: NCT00668798

Childrens Hospital Goethe University
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Principal Investigator: Karl Bauer, Professor Goethe University, Dpt of Neonatology
  More Information

Responsible Party: Prof Karl Bauer, Head of Dpt. of Neonatology, Goethe University, Frankfurt Identifier: NCT00668798     History of Changes
Other Study ID Numbers: CMV/MM0105/FFM
Study First Received: April 25, 2008
Last Updated: April 28, 2008
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 processed this record on November 30, 2015