Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

Cytomegalovirus Clinical Trial

Official title:

Incidence and Clinical Outcome of Human Cytomegalovirus Transmission Via Thawed Frozen Breast Milk in Preterm Infants <31 Weeks. A Prospective Trial.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00668798
• Other study ID #: CMV/MM0105/FFM
• Status: Suspended
• Phase: N/A
• First received: April 25, 2008
• Last updated: April 28, 2008
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Consumer's Safety and Veterinarian Medicine
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 58
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus

Locations

Country	Name	City	State
Germany	Childrens Hospital Goethe University	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV status of preterm infants		2005-2008	No
Secondary	clinical manifestations of CMV infection		2005-2008	No