NCT00668798

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

April 29, 2008

Status Verified

April 1, 2008

Enrollment Period

3 years

First QC Date

April 25, 2008

Last Update Submit

April 28, 2008

Conditions

Cytomegalovirus

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • CMV status of preterm infants

    2005-2008

Secondary Outcomes (1)

  • clinical manifestations of CMV infection

    2005-2008

Study Arms (2)

A

mother CMV positive

B

mother CMV negative

Eligibility Criteria

Age24 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

preterm infants of less than 32 weeks of gestation

You may qualify if:

  • preterm infants of less than 32 weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital Goethe University

Frankfurt, 60590, Germany

Location

Related Publications (1)

  • 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. doi: 10.1016/S0140-6736(00)04043-5.

    PMID: 11229670BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

thawed frozen breast milk of lactating mothers

Study Officials

  • Karl Bauer, Professor

    Goethe University, Dpt of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

January 1, 2005

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

April 29, 2008

Record last verified: 2008-04

Locations

DE(1)