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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01178905
• Collaborator: (none)
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infection; Preterm Infants	Procedure: ultrashort heat inactivation	N/A

Study Design

• Study Type: Interventional
• Allocation: N/A
• 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
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Mother CMV positive	Procedure: ultrashort heat inactivation

Outcome Measures

Primary Outcome Measures

1. Number of participants with CMV viruria [40 weeks gestational age, or at discharge from NICU (if this is earlier)]

Secondary Outcome Measures

1. Number of participants with specific neonatal outcome parameters as a measure of neonatal quality [40 weeks of gestational age or at discharge from NICU (if this is earlier)]

   Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Weeks to 40 Weeks
• Sexes Eligible for Study: All

Inclusion Criteria:

• <32 Weeks or GA or <1500g BW

• mother CMV IgG positive

• breast milk feeding

Exclusion Criteria:

• parents disagree

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tuebingen University Hospital	Tuebingen		Germany	72070

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Rangamr Goelz, MD, Tuebingen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01178905
• Other Study ID Numbers: BM CMV inactivation
• First Posted: Aug 10, 2010
• Last Update Posted: Apr 24, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: Postnatal CMV infection of preterm infants; breast milk
• Additional relevant MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Premature Birth

Study Results

No Results Posted as of Apr 24, 2013