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Completed

NCT Number: NCT01178905

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

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.

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Preterm Infants Virus Diseases

Age range

23 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuebingen University Hospital

Tübingen, 72070, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • parents disagree

Treatment and study plan

ultrashort heat inactivation

Procedure

Primary outcomes

  1. Number of participants with CMV viruria

    Time frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)

Secondary outcomes

  1. 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)

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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
First posted
Aug 10, 2010
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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