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

Preterm Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178905
• Other study ID #: BM CMV inactivation
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: April 23, 2013
• Start date: August 2010

Study information

• Verified date: February 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministery of Science, Baden WuerttembergFaculty of the Tuebingen University Hospital: Tuebingen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2012
• Gender: Both
• Age group: 23 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

• <32 Weeks or GA or <1500g BW

• mother CMV IgG positive

• breast milk feeding

Exclusion Criteria:

• parents disagree

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection
• Premature Birth
• Preterm Infants

Intervention

Procedure:
• ultrashort heat inactivation

Locations

Country	Name	City	State
Germany	Tuebingen University Hospital	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with CMV viruria		40 weeks gestational age, or at discharge from NICU (if this is earlier)	Yes
Secondary	Number of participants with specific neonatal outcome parameters as a measure of neonatal quality	Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)	40 weeks of gestational age or at discharge from NICU (if this is earlier)	Yes