Congenital CytomegaloviruscCMVNCT05630898
Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence)
An observational study of Congenital Cytomegalovirus, run by Hospital de Niños R. Gutierrez de Buenos Aires at 3 sites in Argentina.
Trial summary
The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life. Read more about this study
- Who is it for?
- Ages 1 day to 21 days
- Conditions the study is for
- Congenital Cytomegalovirus
- What is being tested?
- CMV PCR
- How many people
- 3,000 participants
- Where
- 3 sitesArgentina
- Study dates
- 1 Apr 2023to 30 Dec 2024
- Phase
- Observational
- 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 1 day to 21 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborns
Who may be able to join
- Newborns between 1 and 21 days
- informed consent
Who cannot join
- Lethal malformation
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Clinica y maternidad Suizo Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1015
Daniela Satragno, 01141596704, dsatragno@gmail.com
Hospital Materno Infantil Ramón Sardá
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1246
Daniela Satragno, 01141596704, dsatragno@gmail.com
Hospital de Niños Ricardo Gutiérrez
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425
Daniela Satragno, MD, 01141596704, dsatragno@gmail.com
About this study
Official title: Congenital Cytomegalovirus: Prevalence in Buenos Aires City
The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life.
Participants will be screened with a salive swab for CMV DNA. Babies with positive results will be follow up for one year.
Read the detailed description
Cytomegalovirus (CMV) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. In most infants with congenital CMV infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. However, sensorineural hearing loss eventually develops in approximately 10 to 15% of CMV positive children.
The prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). There is not any publication of the prevalence of cCMV in Buenos Aires City. We aim the study to find the prevalence in this population Screening of newborns for CMV infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development.
Testing saliva via DNA detection of the virus through polymerase chain reaction testing (PCR) or rapid culture is shown to have a high sensitivity (>97%) and specificity (99%) for detecting congenital CMV infection.
Our objective is to describe the prevalence of cCMV using saliva specimens for PCR detection.
Secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.
- Conditions
- Congenital Cytomegalovirus
- Being tested
- CMV PCR
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV PCRDiagnostic test
Saliva CMV PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of cCMV
newborns positive for CMV
Measured: 5 months
Secondary outcomes (2)
incidence of neurosensorial hearing loss during the 1° year of life
fail Hearing test
Measured: 1 year
incidence of visual impairments detected during the 1° year of life
anormal eye exam
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Apr 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Congenital CytomegalovirusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Satragno, MD, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Daniela Satragno, MD, Principal investigator, Hospital de Niños Ricardo Gutierrez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630898
- Sponsor's protocol ID
- HNinosBuenosAires
- Acronym
- cCMV
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salmerón MB. Estimación de prevalencia de infección congénita por citomegalovirus y seroprevalencia materna en Tucumán. Rev Argent Salud Pública. 2021;13:e33.
Marín y col. - Citomegalovirosis congénita en población asintomática de recién nacidos de un hospital público en la Región Nordeste de Argentina. Rev Argent salud Pública, 2014; 5(20): 6-10
Manicklal S, Emery VC, Lazzarotto T, Boppana SB, Gupta RK. The "silent" global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013 Jan;26(1):86-102. doi: 10.1128/CMR.00062-12.
PubMed 23297260Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007 Jul-Aug;17(4):253-76. doi: 10.1002/rmv.535.
PubMed 17579921Stagno S, Pass RF, Dworsky ME, Henderson RE, Moore EG, Walton PD, Alford CA. Congenital cytomegalovirus infection: The relative importance of primary and recurrent maternal infection. N Engl J Med. 1982 Apr 22;306(16):945-9. doi: 10.1056/NEJM198204223061601.
PubMed 6278309Wang C, Zhang X, Bialek S, Cannon MJ. Attribution of congenital cytomegalovirus infection to primary versus non-primary maternal infection. Clin Infect Dis. 2011 Jan 15;52(2):e11-3. doi: 10.1093/cid/ciq085.
PubMed 21288834Rawlinson WD, Boppana SB, Fowler KB, Kimberlin DW, Lazzarotto T, Alain S, Daly K, Doutre S, Gibson L, Giles ML, Greenlee J, Hamilton ST, Harrison GJ, Hui L, Jones CA, Palasanthiran P, Schleiss MR, Shand AW, van Zuylen WJ. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017 Jun;17(6):e177-e188. doi: 10.1016/S1473-3099(17)30143-3. Epub 2017 Mar 11.
PubMed 28291720Boppana SB, Ross SA, Fowler KB. Congenital cytomegalovirus infection: clinical outcome. Clin Infect Dis. 2013 Dec;57 Suppl 4(Suppl 4):S178-81. doi: 10.1093/cid/cit629.
PubMed 24257422Fowler KB, McCollister FP, Dahle AJ, Boppana S, Britt WJ, Pass RF. Progressive and fluctuating sensorineural hearing loss in children with asymptomatic congenital cytomegalovirus infection. J Pediatr. 1997 Apr;130(4):624-30. doi: 10.1016/s0022-3476(97)70248-8.
PubMed 9108862Cannon MJ, Schmid DS, Hyde TB. Review of cytomegalovirus seroprevalence and demographic characteristics associated with infection. Rev Med Virol. 2010 Jul;20(4):202-13. doi: 10.1002/rmv.655.
PubMed 20564615Gantt S, Dionne F, Kozak FK, Goshen O, Goldfarb DM, Park AH, Boppana SB, Fowler K. Cost-effectiveness of Universal and Targeted Newborn Screening for Congenital Cytomegalovirus Infection. JAMA Pediatr. 2016 Dec 1;170(12):1173-1180. doi: 10.1001/jamapediatrics.2016.2016.
PubMed 27723885Boppana SB, Ross SA, Shimamura M, Palmer AL, Ahmed A, Michaels MG, Sanchez PJ, Bernstein DI, Tolan RW Jr, Novak Z, Chowdhury N, Britt WJ, Fowler KB; National Institute on Deafness and Other Communication Disorders CHIMES Study. Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns. N Engl J Med. 2011 Jun 2;364(22):2111-8. doi: 10.1056/NEJMoa1006561.
PubMed 21631323Pinninti SG, Ross SA, Shimamura M, Novak Z, Palmer AL, Ahmed A, Tolan RW Jr, Bernstein DI, Michaels MG, Sanchez PJ, Fowler KB, Boppana SB; National Institute on Deafness and Other Communication Disorders CMV and Hearing Multicenter Screening (CHIMES) Study. Comparison of saliva PCR assay versus rapid culture for detection of congenital cytomegalovirus infection. Pediatr Infect Dis J. 2015 May;34(5):536-7. doi: 10.1097/INF.0000000000000609.
PubMed 25876092Ross SA, Ahmed A, Palmer AL, Michaels MG, Sanchez PJ, Bernstein DI, Tolan RW Jr, Novak Z, Chowdhury N, Fowler KB, Boppana SB; National Institute on Deafness and Other Communication Disorders CHIMES Study. Detection of congenital cytomegalovirus infection by real-time polymerase chain reaction analysis of saliva or urine specimens. J Infect Dis. 2014 Nov 1;210(9):1415-8. doi: 10.1093/infdis/jiu263. Epub 2014 May 5.
PubMed 24799600Yamamoto AY, Mussi-Pinhata MM, Marin LJ, Brito RM, Oliveira PF, Coelho TB. Is saliva as reliable as urine for detection of cytomegalovirus DNA for neonatal screening of congenital CMV infection? J Clin Virol. 2006 Jul;36(3):228-30. doi: 10.1016/j.jcv.2006.03.011. Epub 2006 Jun 5.
PubMed 16750653
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Cytomegalovirus: Prevalence in Buenos Aires City
- ClinicalTrials.gov ID
- NCT05630898
- Acronym / sponsor ID
- cCMV / HNinosBuenosAires
- Conditions
- Congenital Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Nov 2022 (actual)
- 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.
The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life.
Participants will be screened with a salive swab for CMV DNA. Babies with positive results will be follow up for one year.
Detailed description
Cytomegalovirus (CMV) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. In most infants with congenital CMV infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. However, sensorineural hearing loss eventually develops in approximately 10 to 15% of CMV positive children.
The prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). There is not any publication of the prevalence of cCMV in Buenos Aires City. We aim the study to find the prevalence in this population Screening of newborns for CMV infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development.
Testing saliva via DNA detection of the virus through polymerase chain reaction testing (PCR) or rapid culture is shown to have a high sensitivity (>97%) and specificity (99%) for detecting congenital CMV infection.
Our objective is to describe the prevalence of cCMV using saliva specimens for PCR detection.
Secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns
Key inclusion criteria (2 listed)
- Newborns between 1 and 21 days
- informed consent
Key exclusion criteria (1 listed)
- Lethal malformation
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 |
|---|---|---|
| CMV PCRSaliva CMV PCR | Diagnostic test | – |
Primary outcome
prevalence of cCMV
Time frame: 5 months
newborns positive for CMV
2 secondary outcomes
incidence of neurosensorial hearing loss during the 1° year of life
Time frame: 1 year
incidence of visual impairments detected during the 1° year of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- BackgroundSalmerón MB. Estimación de prevalencia de infección congénita por citomegalovirus y seroprevalencia materna en Tucumán. Rev Argent Salud Pública. 2021;13:e33.
- BackgroundMarín y col. - Citomegalovirosis congénita en población asintomática de recién nacidos de un hospital público en la Región Nordeste de Argentina. Rev Argent salud Pública, 2014; 5(20): 6-10
- Results publication: PubMed 23297260Manicklal S, Emery VC, Lazzarotto T, Boppana SB, Gupta RK. The "silent" global burden of congenital cytomegalovirus. Clin Microbiol Rev. 2013 Jan;26(1):86-102. doi: 10.1128/CMR.00062-12.
- Results publication: PubMed 17579921Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007 Jul-Aug;17(4):253-76. doi: 10.1002/rmv.535.
- Results publication: PubMed 6278309Stagno S, Pass RF, Dworsky ME, Henderson RE, Moore EG, Walton PD, Alford CA. Congenital cytomegalovirus infection: The relative importance of primary and recurrent maternal infection. N Engl J Med. 1982 Apr 22;306(16):945-9. doi: 10.1056/NEJM198204223061601.
- Results publication: PubMed 21288834Wang C, Zhang X, Bialek S, Cannon MJ. Attribution of congenital cytomegalovirus infection to primary versus non-primary maternal infection. Clin Infect Dis. 2011 Jan 15;52(2):e11-3. doi: 10.1093/cid/ciq085.
- Results publication: PubMed 28291720Rawlinson WD, Boppana SB, Fowler KB, Kimberlin DW, Lazzarotto T, Alain S, Daly K, Doutre S, Gibson L, Giles ML, Greenlee J, Hamilton ST, Harrison GJ, Hui L, Jones CA, Palasanthiran P, Schleiss MR, Shand AW, van Zuylen WJ. Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy. Lancet Infect Dis. 2017 Jun;17(6):e177-e188. doi: 10.1016/S1473-3099(17)30143-3. Epub 2017 Mar 11.
- Results publication: PubMed 24257422Boppana SB, Ross SA, Fowler KB. Congenital cytomegalovirus infection: clinical outcome. Clin Infect Dis. 2013 Dec;57 Suppl 4(Suppl 4):S178-81. doi: 10.1093/cid/cit629.
- Results publication: PubMed 9108862Fowler KB, McCollister FP, Dahle AJ, Boppana S, Britt WJ, Pass RF. Progressive and fluctuating sensorineural hearing loss in children with asymptomatic congenital cytomegalovirus infection. J Pediatr. 1997 Apr;130(4):624-30. doi: 10.1016/s0022-3476(97)70248-8.
- Results publication: PubMed 20564615Cannon MJ, Schmid DS, Hyde TB. Review of cytomegalovirus seroprevalence and demographic characteristics associated with infection. Rev Med Virol. 2010 Jul;20(4):202-13. doi: 10.1002/rmv.655.
- Results publication: PubMed 27723885Gantt S, Dionne F, Kozak FK, Goshen O, Goldfarb DM, Park AH, Boppana SB, Fowler K. Cost-effectiveness of Universal and Targeted Newborn Screening for Congenital Cytomegalovirus Infection. JAMA Pediatr. 2016 Dec 1;170(12):1173-1180. doi: 10.1001/jamapediatrics.2016.2016.
- Results publication: PubMed 21631323Boppana SB, Ross SA, Shimamura M, Palmer AL, Ahmed A, Michaels MG, Sanchez PJ, Bernstein DI, Tolan RW Jr, Novak Z, Chowdhury N, Britt WJ, Fowler KB; National Institute on Deafness and Other Communication Disorders CHIMES Study. Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns. N Engl J Med. 2011 Jun 2;364(22):2111-8. doi: 10.1056/NEJMoa1006561.
- Individual participant dataSharing planned: No
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Cytomegalovirus Infection
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.
Daniela Satragno, MD principal investigator
Hospital de Niños Ricardo Gutierrez
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cytomegalovirus, run by Hospital de Niños R. Gutierrez de Buenos Aires at 3 sites in Argentina.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Satragno, MD (+541149625649, dsatragno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of cCMV (time frame: 5 months). 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 NCT05630898, which also lists 18 linked publications.
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 30 Nov 2022.