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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, P-E, Pryds, O & Ravn, H 2017, 'BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial' Archives of Disease in Childhood, vol. 102, no. 3, pp. 224-231. https://doi.org/10.1136/archdischild-2016-310760

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Author

Stensballe, Lone Graff ; Sørup, Signe ; Aaby, Peter ; Benn, Christine Stabell ; Greisen, Gorm ; Jeppesen, Dorthe Lisbeth ; Birk, Nina Marie ; Kjærgaard, Jesper ; Nissen, Thomas Nørrelykke ; Pihl, Gitte Thybo ; Thøstesen, Lisbeth Marianne ; Kofoed, Poul-Erik ; Pryds, Ole ; Ravn, Henrik. / BCG vaccination at birth and early childhood hospitalisation : a randomised clinical multicentre trial. In: Archives of Disease in Childhood. 2017 ; Vol. 102, No. 3. pp. 224-231.

Bibtex

@article{2af3a147cc90422385c986db8b7cf39a,
title = "BCG vaccination at birth and early childhood hospitalisation: a randomised clinical multicentre trial",
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.",
author = "Stensballe, {Lone Graff} and Signe S{\o}rup and Peter Aaby and Benn, {Christine Stabell} and Gorm Greisen and Jeppesen, {Dorthe Lisbeth} and Birk, {Nina Marie} and Jesper Kj{\ae}rgaard and Nissen, {Thomas N{\o}rrelykke} and Pihl, {Gitte Thybo} and Th{\o}stesen, {Lisbeth Marianne} and Poul-Erik Kofoed and Ole Pryds and Henrik Ravn",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",
year = "2017",
month = "2",
day = "1",
doi = "10.1136/archdischild-2016-310760",
language = "English",
volume = "102",
pages = "224--231",
journal = "Archives of Disease in Childhood",
issn = "0003-9888",
publisher = "B M J Group",
number = "3",

}

RIS

TY - JOUR

T1 - BCG vaccination at birth and early childhood hospitalisation

T2 - a randomised clinical multicentre trial

AU - Stensballe, Lone Graff

AU - Sørup, Signe

AU - Aaby, Peter

AU - Benn, Christine Stabell

AU - Greisen, Gorm

AU - Jeppesen, Dorthe Lisbeth

AU - Birk, Nina Marie

AU - Kjærgaard, Jesper

AU - Nissen, Thomas Nørrelykke

AU - Pihl, Gitte Thybo

AU - Thøstesen, Lisbeth Marianne

AU - Kofoed, Poul-Erik

AU - Pryds, Ole

AU - Ravn, Henrik

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

AB - 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.

U2 - 10.1136/archdischild-2016-310760

DO - 10.1136/archdischild-2016-310760

M3 - Journal article

VL - 102

SP - 224

EP - 231

JO - Archives of Disease in Childhood

JF - Archives of Disease in Childhood

SN - 0003-9888

IS - 3

ER -

ID: 48333805