This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

This study has suspended participant recruitment.
Information provided by:
Johann Wolfgang Goethe University Hospital 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 Hospital:

Primary Outcome Measures:
  • CMV status of preterm infants [ Time Frame: 2005-2008 ]

Secondary Outcome Measures:
  • clinical manifestations of CMV infection [ Time Frame: 2005-2008 ]

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00668798

Childrens Hospital Goethe University
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
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

Keywords provided by Johann Wolfgang Goethe University Hospital:
cytomegalovirus breast milk preterm infants transmission
transmission of CMV via thawed frozen breast milk processed this record on August 16, 2017