Sep 05, 2024
Study protocol: can viral load predict a symptomatic congenital CMV infection? A systematic review and meta-analysis
- Serena Salomè1,
- Roberta Gammella1,
- Clara Coppola2,
- Pasquale Dolce3,
- Letizia Capasso4,
- Daniel Blasquez-Gamero5
- 1University of Naples Federico II;
- 2Department of traslactional medical sciences, division of Neonatology, University of Naples Federico II;
- 3Department of traslactional medical sciences, University of Naples Federico II;
- 4Department of traslactional medical sciences, division of Neonatology, University of Naples Federico II;
- 5Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Universidad Complutense, Instituto de Investigación Hospital 12 de Octubre (Imas12), Translational Research, Network in Pediatric Infectious Diseases (RITIP), Madrid, Spain
Protocol Citation: Serena Salomè, Roberta Gammella, Clara Coppola, Pasquale Dolce, Letizia Capasso, Daniel Blasquez-Gamero 2024. Study protocol: can viral load predict a symptomatic congenital CMV infection? A systematic review and meta-analysis. protocols.io https://dx.doi.org/10.17504/protocols.io.14egn61qml5d/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: September 05, 2024
Last Modified: September 05, 2024
Protocol Integer ID: 107027
Keywords: congenital CMV, viral load, sequelae
Abstract
CMV is the most common cause of congenital infection.
Although only approximately 10% of infected newborns are symptomatic at birth,
a clinical disease may develop later in infancy. An early diagnosis of
symptomatic cCMV is important for successful treatment.
Our objective was to
evaluate if a higher viral load in different biological fluids correlates with
symptomatic disease. We will perform a systematic searches of Medline, Embase,
and SCOPUS from 1976 to December 2023. Methods will follow the Preferred Reporting
Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines and
it has been registered with the
International Prospective Register of Systematic Reviews (PROSPERO) on 03/05/24
(Registration number CRD42024537242). Our primary outcome will be to evaluate
if great CMV load in blood and urine may predict newborns at risk of symptoms. As
secondary outcome, we will search if higher CMV may influence long term
prognosis and if there is a specific threshold
Attachments
Protocol references
1. Mussi-Pinhata MM, Yamamoto AY, Brito RMM, et al. Birth prevalence and natural history
of congenital cytomegalovirus infection in a highly seroimmune population.
Clinical Infectious Diseases. 2009;49(4):522-528. doi:10.1086/600882
2. Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital
cytomegalovirus (CMV) infection. Rev Med Virol. 2007;17(4):253-276. doi:10.1002/rmv.535
3. Rawlinson WD, Boppana SB, Fowler KB, et al. Congenital cytomegalovirus infection in
pregnancy and the neonate: consensus recommendations for prevention, diagnosis,
and therapy. Lancet Infect Dis. 2017 ;17(6) : e177-e188. Doi :10.1016/S1473-3099(17)30143-3
4. Jones CE, Bailey H, Bamford A, et al. Managing challenges in congenital CMV: Current thinking. Arch Dis Child. 2023;108(8):601-607. doi:10.1136/archdischild-2022-323809
5. Dollard SC, Grosse SD, Ross DS. New estimates of the prevalence of neurological and sensory sequelae and mortality associated with congenital cytomegalovirus infection. Rev Med Virol. 2007;17(5):355-363. doi:10.1002/rmv.544
6. Cannon MJ, Griffiths PD, Aston V, Rawlinson WD. Universal newborn screening for congenital CMV infection: What is the evidence of potential benefit? Rev Med Virol. 2014;24(5):291-307. doi:10.1002/rmv.1790
7. Puhakka L, Lappalainen M, Lönnqvist T, et al. The burden of congenital cytomegalovirus infection: A prospective cohort study of 20 000 infants in Finland. J Pediatric Infect Dis Soc. 2019;8(3):205-212. doi:10.1093/jpids/piy027
8. Pinninti SG, Rodgers MD, Novak Z, et al. Clinical predictors of sensorineural hearing loss and cognitive outcome in infants with symptomatic congenital cytomegalovirus infection. Pediatric Infectious Disease Journal. 2016;35(8):924-926. doi:10.1097/INF.000000000000119
9. Lanari M, Lazzarotto T, Venturi V, et al. Neonatal cytomegalovirus blood load and risk of sequelae in symptomatic and asymptomatic congenitally infected newborns. Pediatrics. 2006;117(1).
doi:10.1542/peds.2005-0629
10. Marsico C, Aban I, Kuo H, et al. Blood Viral Load in Symptomatic Congenital Cytomegalovirus Infection. Journal of Infectious Diseases. 2019;219(9):1398-1406. doi:10.1093/infdis/jiy695
11. Forner G, Abate D, Mengoli C, Palù G, Gussetti N. High cytomegalovirus (CMV) DNAemia predicts CMV sequelae in asymptomatic congenitally infected newborns born to women with primary infection during pregnancy. Journal of Infectious Diseases. 2015;212(1):67-71. doi:10.1093/infdis/jiu627
12. Fourgeaud J, Magny JF, Couderc S, et al. Clinical value of serial quantitative analysis of cytomegalovirus DNA in blood and saliva over the first 24 months of life congenital infection: the French Cymepedia Cohort. J Pediatr. 2023; 253:197-204. doi: 10.1016/j.jpeds.2022.09.040ï