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BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial.

BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial.
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Stensballe LG, Sørup S, Aaby P, Benn CS, Greisen G, Jeppesen DL, Birk NM, Kjærgaard J, Nissen TN, Pihl GT, Thøstesen LM, Kofoed PE, Pryds O, Ravn H,


Stensballe LG, Sørup S, Aaby P, Benn CS, Greisen G, Jeppesen DL, Birk NM, Kjærgaard J, Nissen TN, Pihl GT, Thøstesen LM, Kofoed PE, Pryds O, Ravn H, (click to view)

Stensballe LG, Sørup S, Aaby P, Benn CS, Greisen G, Jeppesen DL, Birk NM, Kjærgaard J, Nissen TN, Pihl GT, Thøstesen LM, Kofoed PE, Pryds O, Ravn H,

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Archives of disease in childhood 2016 07 21102(3) 224-231 doi 10.1136/archdischild-2016-310760
Abstract
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.

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