Bacillus Calmette-Guérin vaccination at birth: Effects on infant growth. A randomized clinical trial

Jesper Kjærgaard, Lone Graff Stensballe, Nina Marie Birk, Thomas Nørrelykke Nissen, Lisbeth Marianne Thøstesen, Gitte Thybo Pihl, Agnethe Vale Nielsen, Poul-Erik Kofoed, Peter Aaby, Ole Pryds, Gorm Greisen

6 Citationer (Scopus)

Abstract

BACKGROUND: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation.

AIMS: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition.

STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population.

RESULTS: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months.

CONCLUSION: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months.

TRIAL REGISTRATION: www.clinicaltrials.gov, registration number NCT01694108.

OriginalsprogEngelsk
TidsskriftEarly Human Development
Vol/bind100
Sider (fra-til)49-54
Antal sider6
ISSN0378-3782
DOI
StatusUdgivet - 31 jan. 2016

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