| BackgroundHuman cytomegalovirus(HCMV)is prevalent in humans.Congenital HCMV infection presents with severe clinical symptoms and a complicated long-term prognosis.Sensorineural hearing loss(SNHL)is one of the most common sequelae after HCMV infection,which seriously affects the prognosis of children.For a long time,the risk assessment,clinical management and long-term prognosis of HCMV infection have received a great deal of medical and social attention.However,there are not a sufficient amount of robust evidence-based medical evidence to support these ideas.Moreover,systematic observation of clinical cohorts of HCMV infection is scarce around the world.ObjectiveTo provide evidence-based medicine for the clinical management of HCMV infection,we attempt to construct a clinical cohort and a long-term follow-up technical system for HCMV-infected children.We intend to perform a retrospective study to initially explore the clinical cohort,which will lay a foundation for the establishment and optimization of the clinical cohort.Methods1.Based on evidence-based medicine,clinical consensus,and results of clinical studies in authoritative journals,we established an HCMV infection cohort standardized indicator set-recording baseline and follow-up plan.The baseline data such as basic information,maternity history,birth history,growth history,laboratory test results,viral load,hearing evaluation results,neurodevelopmental evaluation results,and head imaging examination were collected in this study.According to the technical specification of long-term follow-up for the endpoint,data management,and data security,and in the large population-based cohort study,we defined the endpoint,and determine the follow-up content,follow-up mode,and follow-up interval.Finally,a standardized follow-up system for the diagnosis,treatment,and follow-up of HCMV-infected children is formed.2.According to the HCMV infection cohort standardized indicator set-recording baseline,we collected the data of children hospitalized in Guangdong Maternal and Child Health Hospital from January 2010 to December 2022 and diagnosed with congenital cytomegalovirus infection,and divided them into a hearing pass group and a hearing fail group according to the hearing test results in the neonatal period,and conducted a retrospective analysis.Then we construct a multifactorial logistic regression equation to initially explore the clinical cohort.Results1.Based on evidence-based medicine,we have established the HCMV infection cohort standardized indicator set-recording baseline and follow-up plan.And we initially constructed a database of HCMV-infected children.By December 2022,165 children with HCMV infection had been included,including 101 males and 64 females,with an average age of 18.0(2.5,30.5)days.The number of cases of congenital HCMV infection was 99,while the number of cases of acquired infection was 19,and the number of unknown infection type was 47.Among them,there were120 children with normal hearing and 45 children with hearing loss.2.In the retrospective study,99 children with congenital HCMV infection have been collected,including 56 males and 43 females.Among them,74 cases were in the normal hearing group(male/female 41/33)and 25 cases were in the hearing impairment group(male/female 15/10);the average age of the hearing group was4.5(1.0,15.0)days,and the average age of the different hearing groups was7.0(1.0,19.5)days.In terms of sex and age,there was no statistical difference(P >0.05).The multifactor logistic regression analysis suggested that whole blood HCMV viral blood may be a risk factor for SNHL in congenital HCMV infection(OR=1.712,95%CI 1.025-2.861,P=0.04).The multifactor logistic regression analysis suggested that whole blood HCMV viral blood may be a risk factor for hearing loss in congenital HCMV infection(OR=1.712,95%CI 1.025-2.861,P=0.04).Conclusions.1.We have established a preliminary follow-up system for clinical cohort diagnosis and long-term prognosis in HCMV-infected children.2.The follow-up system for the clinical cohort of HCMV infection which is based on standard specification can provide evidence-based medical evidence for clinical management practices of HCMV infection. |
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