Cytomegalovirus (CMV) Transmission by Frozen Breast Milk... | NCT00668798

Studies
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

NCT00668798

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Suspended

Last Update Posted

Apr 29, 2008Estimated

Enrollment

58Actual

Phase

Not provided

Conditions

Cytomegalovirus

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2008Estimated

Completion Date

Mar 2008Estimated

First Submitted Date

Apr 25, 2008

First Submission Date that Met QC Criteria

Apr 28, 2008

First Posted Date

Apr 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2008

Last Update Posted Date

Apr 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		mother CMV positive
B		mother CMV negative

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CMV status of preterm infants		2005-2008

Secondary Outcomes

Measure	Description	Time Frame
clinical manifestations of CMV infection		2005-2008

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Weeks

Maximum Age

31 Weeks

Standard Ages

Child

Study Population

preterm infants of less than 32 weeks of gestation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl Bauer, Professor	Goethe University, Dpt of Neonatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Childrens Hospital Goethe University		Frankfurt		60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11229670	Background	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.