BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial
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- BCG vaccination at birth and early childhood hospitalisation
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BACKGROUND: The BCG vaccine is administered to protect against tuberculosis, but studies suggest there may also be non-specific beneficial effects upon the infant immune system, reducing early non-targeted infections and atopic diseases. The present randomised trial tested the hypothesis that BCG vaccination at birth would reduce early childhood hospitalisation in Denmark, a high-income setting.
METHODS: Pregnant women planning to give birth at three Danish hospitals were invited to participate. After parental consent, newborn children were allocated to BCG or no intervention within 7 days of age. Randomisation was stratified by prematurity. The primary study outcome was number of all-cause hospitalisations analysed as repeated events. Hospitalisations were identified using The Danish National Patient Register. Data were analysed by Cox proportional hazards models in intention-to-treat and per-protocol analyses.
RESULTS: 4184 pregnant women were randomised and their 4262 children allocated to BCG or no intervention. There was no difference in risk of hospitalisation up to 15 months of age; 2129 children randomised to BCG experienced 1047 hospitalisations with a mean of 0.49 hospitalisation per child compared with 1003 hospitalisations among 2133 control children (mean 0.47), resulting in a HR comparing BCG versus no BCG of 1.05 (95% CI 0.93 to 1.18) (intention-to-treat analysis). The effect of BCG was the same in children born at term (1.05 (0.92 to 1.18)) and prematurely (1.07 (0.63 to 1.81), p=0.94). The effect was also similar in the two sexes and across study sites. The results were essentially identical in the per-protocol analysis and after adjustment for baseline characteristics.
CONCLUSIONS: BCG vaccination at birth did not reduce the risk of hospitalisation for somatic acquired disease until 15 months of age in this Danish study population.
TRIAL REGISTRATION NUMBER: NCT01694108, results.
Original language | English |
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Journal | Archives of Disease in Childhood |
Volume | 102 |
Issue number | 3 |
Pages (from-to) | 224-231 |
Number of pages | 8 |
ISSN | 0003-9888 |
DOIs | |
Publication status | Published - 2017 |
- BCG Vaccine, Child, Preschool, Denmark, Female, Follow-Up Studies, Hospitalization, Humans, Infant, Infant, Newborn, Male, Perinatal Care, Risk Factors, Socioeconomic Factors, Tuberculosis, Journal Article, Multicenter Study, Randomized Controlled Trial
Research areas
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