Abstract
Echocardiographic screening allows for early detection of subclinical stages of rheumatic heart disease among children in endemic regions. To investigate the effectiveness of systematic echocardiographic screening in combination with secondary antibiotic prophylaxis on the prevalence of rheumatic heart disease. This cluster randomized clinical trial included students 9 to 16 years of age attending public and private schools in urban and rural areas of the Sunsari district in Nepal that had been randomly selected on November 17, 2012. Echocardiographic follow-up was performed between January 7, 2016, and January 3, 2019. In the experimental group, children underwent systematic echocardiographic screening followed by secondary antibiotic prophylaxis in case they had echocardiographic evidence of latent rheumatic heart disease. In the control group, children underwent no echocardiographic screening. Prevalence of the composite of definite or borderline rheumatic heart disease according to the World Heart Federation criteria in experimental and control schools as assessed 4 years after intervention. A total of 35 schools were randomized to the experimental group (n = 19) or the control group (n = 16). After a median of 4.3 years (interquartile range [IQR], 4.0-4.5 years), 17 of 19 schools in the experimental group (2648 children; median age at follow-up, 12.1 years; IQR, 10.3-12.5 years; 1308 [49.4%] male) and 15 of 16 schools in the control group (1325 children; median age at follow-up, 10.6 years; IQR, 10.0-12.5 years; 682 [51.5%] male) underwent echocardiographic follow-up. The prevalence of definite or borderline rheumatic heart disease was 10.8 per 1000 children (95% CI, 4.7-24.7) in the control group and 3.8 per 1000 children (95% CI, 1.5-9.8) in the experimental group (odds ratio, 0.34; 95% CI, 0.11-1.07; P = .06). The prevalence in the experimental group at baseline had been 12.9 per 1000 children (95% CI, 9.2-18.1). In the experimental group, the odds ratio of definite or borderline rheumatic heart disease at follow-up vs baseline was 0.29 (95% CI, 0.13-0.65; P = .008). School-based echocardiographic screening in combination with secondary antibiotic prophylaxis in children with evidence of latent rheumatic heart disease may be an effective strategy to reduce the prevalence of definite or borderline rheumatic heart disease in endemic regions. ClinicalTrials.gov Identifier: NCT01550068.
Highlights
Thirty-five schools were included in the study and randomized to the experimental group (n = 19) or the control group (n = 16) (Figure 1)
Between December 12, 2012, and August 22, 2014, all eligible children 5 to 12 years of age from the 19 schools in the experimental group underwent echocardiographic screening at baseline, whereas no screening was performed in the 16 schools in the control group
Between January 7, 2016, and January 3, 2019, after a median interval of 4.3 years, children aged 9 to 16 years at 17 experimental and 15 control schools underwent follow-up; 2 experimental schools were unavailable for follow-up because of a logistical error, and 1 control school had been closed after randomization
Summary
Setting and Design In December 2012, we launched a school-based echocardiographic screening program in an evaluable random sample of schools in the Sunsari district of Nepal, which was planned in collaboration with the district education office.[8] The Sunsari district is situated on the foothills of the lower Himalayan range in the eastern development region of Nepal and is part of the Outer Terai of the Koshi zone. Central random sampling of schools, stratified by setting (rural vs urban) and administration of the school (public vs private), was performed on November 17, 2012. Rural to urban schools were selected in a 3:1 ratio and public to private schools in a 2:1 ratio to reflect the distribution of all children in the educational system in Nepal.[11] The trial protocol can be found in Supplement 1.
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