Burden of sequelae and healthcare resource utilization in the first year of life in infants born with congenital cytomegalovirus (cCMV) infection in Germany: A retrospective statutory health insurance claims database analysis

PLoS One. 2023 Nov 16;18(11):e0293869. doi: 10.1371/journal.pone.0293869. eCollection 2023.

Abstract

Background: Congenital cytomegalovirus (cCMV) infection can have a broad range of manifestations. This study aimed to assess cCMV-associated sequelae and healthcare resource utilization (HCRU) in infants during the first year of life in Germany.

Methods: A retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database was conducted. cCMV-associated sequelae and HCRU during the first year of life were assessed by matching (1:60) infants with at least one inpatient/outpatient cCMV diagnosis (ICD-10-GM: P35.1) ≤90 days after birth (cCMV90 cohort) and infants with at least one inpatient cCMV diagnosis plus specific sequelae ≤21 days after birth (cCMV21-S) to infants without cCMV or CMV (ICD-10-GM: B25) diagnosis (control group), respectively. Outcomes were analyzed during the first 365 days of life.

Results: Between 2014-2018, we identified 54 newborns for cCMV90 and 24 newborns for cCMV21-S cohort. Compared to the 3,240 and 1,440 controls, respectively, more cCMV90 infants (83.3% vs. 41.9%, p<0.01) presented with at least one sequela during the first year of life, including intrauterine growth retardation (42.6% vs. 5.3%, p<0.01), sensorineural hearing loss (SNHL) to deafness (38.9% vs. 2.2%, p<0.01), and motor development disorders (33.3% vs. 10.9%, p<0.01). Further, 13.0% of cCMV90 infants (vs. 2.3%, p<0.01) suffered from visual impairment. In cCMV21-S cohort, intrauterine growth retardation (79.2% vs. 6.0%, p<0.01), prematurity (54.2% vs. 7.3%, p<0.01), and motor development disorders (50.0% vs. 11.0%, p<0.01) were the most frequent sequelae. Infants in the cCMV90 and cCMV21-S cohort had, on average, 7.3 times and 9.5 times more hospitalizations and 2.0 times and 2.1 times more outpatient physician visits than their respective controls (p<0.01). Hospitalized infants with cCMV stayed, on average, significantly longer in hospital compared to their controls (cCMV90 cohort: 30.3 days vs. 9.0 days, p<0.01; cCMV21-S cohort: 46.5 days vs. 9.3 days, p<0.01).

Conclusions: cCMV-infection shows a considerable disease and healthcare burden during the first year of life. More than 80% of the identified newborns with cCMV suffered from at least one associated sequela during the first year of life, including long-term sequelae such as SNHL (40%) and visual impairment (13%). Additional steps for prevention of cCMV infection and associated sequelae as well as a comprehensive monitoring of disease burden are needed.

MeSH terms

  • Cohort Studies
  • Cytomegalovirus
  • Cytomegalovirus Infections* / complications
  • Cytomegalovirus Infections* / diagnosis
  • Cytomegalovirus Infections* / epidemiology
  • Female
  • Fetal Growth Retardation
  • Germany / epidemiology
  • Hearing Loss, Sensorineural* / complications
  • Humans
  • Infant
  • Infant, Newborn
  • Insurance, Health
  • Patient Acceptance of Health Care
  • Retrospective Studies
  • Vision Disorders / complications

Grants and funding

MSD Sharp & Dohme GmbH funded the study and provided further support in the form of salaries [ML, AJS, RW, AL, MR] and expert honoraria for some of the authors [HB, RG, KH, PK, SM], which are described in detail in the “competing interests” section. The specific roles of these authors are articulated in the “author contributions” section. The funder approved the study design and manuscript for scientific integrity. The funder had no role in data collection and analysis as well as decision to publish.