Lisbeth Marianne Thøstes, from Kolding Hospital in Denmark, and colleagues randomized newborns within seven days of birth to BCG or no BCG as part of the Danish Calmette Study. Over 13 months of follow-up, data were collected through telephone interviews and clinical examinations. The researchers in a randomised trial tried to establish the relation between BCG and allergic disorders in neonates.The Danish Calmette Study was conducted 2012-2015. Within 7 days of birth, newborns were randomised 1:1 to BCG or no BCG. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency or no Danish-speaking parent. Data were collected through telephone interviews and clinical examinations until 13 months.
Clinical atopic dermatitis was diagnosed in 466/2,052 (22.7%) children in the BCG group and 495/1,952 (25.4%) children in the control group (RR=0.90 (95% confidence intervals 0.80 to 1.00)). The effect of neonatal BCG vaccination differed significantly between children with atopic predisposition (RR 0.84 (0.74 to 0.95)) and children without atopic predisposition (RR 1.09 (0.88 to 1.37)) (test of no interaction, p=0.04).
Among children with atopic predisposition, the number-needed-to-treat with BCG to prevent one case of atopic dermatitis was 21 (12 to 76).
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