Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00668798
First received: April 25, 2008
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

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


Condition
Cytomegalovirus

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.

Resource links provided by NLM:


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)
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
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 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:
Responsible Party: Prof Karl Bauer, Head of Dpt. of Neonatology, Goethe University, Frankfurt
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on October 29, 2014