TY - JOUR
T1 - Bacillus Calmette-Guérin vaccination at birth
T2 - Effects on infant growth. A randomized clinical trial
AU - Kjærgaard, Jesper
AU - Stensballe, Lone Graff
AU - Birk, Nina Marie
AU - Nissen, Thomas Nørrelykke
AU - Thøstesen, Lisbeth Marianne
AU - Pihl, Gitte Thybo
AU - Vale Nielsen, Agnethe
AU - Kofoed, Poul-Erik
AU - Aaby, Peter
AU - Pryds, Ole
AU - Greisen, Gorm
N1 - Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1016/j.earlhumdev.2016.05.015
DO - 10.1016/j.earlhumdev.2016.05.015
M3 - Journal article
C2 - 27394195
SN - 0378-3782
VL - 100
SP - 49
EP - 54
JO - Early Human Development
JF - Early Human Development
ER -
