title: Bacillus Calmette-Guérin vaccination at birth: Effects on infant growth. A randomized clinical trial.
abstract: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation.
  
  
  
  The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition.
  
  
  
  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.
  
  
  
  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.
  
  
  
  In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months.
  
  
  
  www.clinicaltrials.gov, registration number NCT01694108.
authors.affiliation: Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark; The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. Electronic address: Jesper.kjaergaard@regionh.dk.
authors.forename: Jesper
authors.initials: J
authors.lastname: Kjærgaard
authors.affiliation: Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
authors.forename: Lone Graff
authors.initials: LG
authors.lastname: Stensballe
authors.affiliation: Department of Paediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.
authors.forename: Nina Marie
authors.initials: NM
authors.lastname: Birk
authors.affiliation: Department of Paediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.
authors.forename: Thomas Nørrelykke
authors.initials: TN
authors.lastname: Nissen
authors.affiliation: Department of Paediatrics, Kolding Hospital, Skovvangen 2-8, DK-6000 Kolding, Denmark; Institute of Regional Health Research, University of Southern Denmark, Denmark.
authors.forename: Lisbeth Marianne
authors.initials: LM
authors.lastname: Thøstesen
authors.affiliation: Department of Paediatrics, Kolding Hospital, Skovvangen 2-8, DK-6000 Kolding, Denmark; Institute of Regional Health Research, University of Southern Denmark, Denmark.
authors.forename: Gitte Thybo
authors.initials: GT
authors.lastname: Pihl
authors.affiliation: Research Unit Womens' and Childrens' Health, The Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
authors.forename: Agnethe Vale
authors.initials: AV
authors.lastname: Nielsen
authors.affiliation: Department of Paediatrics, Kolding Hospital, Skovvangen 2-8, DK-6000 Kolding, Denmark; Institute of Regional Health Research, University of Southern Denmark, Denmark.
authors.forename: Poul-Erik
authors.initials: PE
authors.lastname: Kofoed
authors.affiliation: Bandim Health Project, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen S, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Aaby
authors.affiliation: Department of Paediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.
authors.forename: Ole
authors.initials: O
authors.lastname: Pryds
authors.affiliation: The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
mesh_terms: D000886:Anthropometry; D001500:BCG Vaccine / Q000009:adverse effects*; D001823:Body Composition; D001827:Body Height; D003718:Denmark; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006785:Hospitals, University; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D012016:Reference Values; D012885:Skinfold Thickness; D014611:Vaccination / Q000009:adverse effects*; D015430:Weight Gain; D014944:World Health Organization
chemical_list: D001500:BCG Vaccine
keywords: BCG; Body composition; Child growth; Inflammation; Non-specific effect; Obesity