Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01178905
First received: July 26, 2010
Last updated: April 23, 2013
Last verified: February 2013
History of Changes
  Purpose

To evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of Cytomegalovirus (CMV) transmission in preterm infants (<32 weeks gestational age or <1500 g birth weight) under clinical conditions. Inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of BM and urine of the infant. Thus the investigators hypothesis is that no CMV transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk.

The protocol has been approved by the ethics committee of Tuebingen University Hospital.


Condition Intervention
Cytomegalovirus Infection
Preterm Infants
 Procedure: ultrashort heat inactivation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Official Title: Clinical Evaluation of a Gentle But Safe Ultrashort-term Heat Inactivation Procedure of Raw Breast Milk (BM) Containing Virulent Cytomegalovirus for Preventing CMV-infection of Preterm Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Number of participants with CMV viruria [ Time Frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with specific neonatal outcome parameters as a measure of neonatal quality [ Time Frame: 40 weeks of gestational age or at discharge from NICU (if this is earlier) ] [ Designated as safety issue: Yes ]
    Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)
Study Start Date: August 2010
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mother CMV positive Procedure: ultrashort heat inactivation

  Eligibility
Ages Eligible for Study:   23 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • <32 Weeks or GA or <1500g BW
  • mother CMV IgG positive
  • breast milk feeding

Exclusion Criteria:

  • parents disagree
  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: NCT01178905

Locations
Germany
Tuebingen University Hospital
Tuebingen, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Rangamr Goelz, MD Tuebingen University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01178905     History of Changes
Other Study ID Numbers: BM CMV inactivation
Study First Received: July 26, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Ministery of Science, Baden Wuerttemberg
Faculty of the Tuebingen University Hospital: Tuebingen

Keywords provided by University Hospital Tuebingen:
Postnatal CMV infection of preterm infants
breast milk

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Infection
 DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on March 02, 2015