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Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

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ClinicalTrials.gov Identifier: NCT00668798
Recruitment Status : Suspended
First Posted : April 29, 2008
Last Update Posted : April 29, 2008
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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

Condition or disease
Cytomegalovirus

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.

Study Type : Observational
Actual Enrollment : 58 participants
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.
Study Start Date : January 2005
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : March 2008

Group/Cohort
A
mother CMV positive
B
mother CMV negative



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

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

Biospecimen Retention:   Samples With DNA
thawed frozen breast milk of lactating mothers


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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668798


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

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
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: April 2008

Keywords provided by Johann Wolfgang Goethe University Hospital:
cytomegalovirus breast milk preterm infants transmission
transmission of CMV via thawed frozen breast milk