Cytomegalovirus InfectionNCT01178905
Clinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
A study testing ultrashort heat inactivation in people with Cytomegalovirus Infection and Preterm Infants, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 23 to 40 weeks
- Conditions the study is for
- Cytomegalovirus Infection, Preterm Infants
- What is being tested?
- ultrashort heat inactivation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 40 weeks
- All sexes
- Child
Who may be able to join
- <32 Weeks or GA or <1500g BW
- mother CMV IgG positive
- breast milk feeding
Who cannot join
- parents disagree
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cytomegalovirus Infection, Preterm Infants
- Being tested
- ultrashort heat inactivation
- Keywords
- Postnatal CMV infection of preterm infants, breast milk
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrashort heat inactivationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mother CMV positive | Other | Not described Receives: Procedure: ultrashort heat inactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with CMV viruria
Measured: 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
Intracranial hemorrhage (ICH) Periventricular leucomalacia (PVL) Necrotizing enterocolitis (NEC) Bronchopulmonary dysplasia (BPD) Retinopathy of prematurity (ROP)
Measured: 40 weeks of gestational age or at discharge from NICU (if this is earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Rangamr Goelz, MD, Principal investigator, Tuebingen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178905
- Sponsor's protocol ID
- BM CMV inactivation
- Status last verified
- Feb 2013
- First submitted
- 26 Jul 2010
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bapistella S, Hamprecht K, Thomas W, Speer CP, Dietz K, Maschmann J, Poets CF, Goelz R. Short-term Pasteurization of Breast Milk to Prevent Postnatal Cytomegalovirus Transmission in Very Preterm Infants. Clin Infect Dis. 2019 Jul 18;69(3):438-444. doi: 10.1093/cid/ciy945.
PubMed 30407512
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01178905
- Acronym / sponsor ID
- BM CMV inactivation
- Conditions
- Cytomegalovirus Infection, Preterm Infants
- Keywords
- Postnatal CMV infection of preterm infants, breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother CMV positive | Other | Procedure: ultrashort heat inactivation |
Who may qualify
- Ages
- 23 to 40 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- <32 Weeks or GA or <1500g BW
- mother CMV IgG positive
- breast milk feeding
Key exclusion criteria (1 listed)
- parents disagree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrashort heat inactivation | Procedure or surgery | Mother CMV positive |
Primary outcome
Number of participants with CMV viruria
Time frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Derived from this study: PubMed 30407512Bapistella S, Hamprecht K, Thomas W, Speer CP, Dietz K, Maschmann J, Poets CF, Goelz R. Short-term Pasteurization of Breast Milk to Prevent Postnatal Cytomegalovirus Transmission in Very Preterm Infants. Clin Infect Dis. 2019 Jul 18;69(3):438-444. doi: 10.1093/cid/ciy945.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rangamr Goelz, MD principal investigator
Tuebingen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrashort heat inactivation in people with Cytomegalovirus Infection and Preterm Infants, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with CMV viruria (time frame: 40 weeks gestational age, or at discharge from NICU (if this is earlier)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.