title: Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial.
abstract: BACKGROUND
  Randomised trials have shown that early Bacille Calmette-Guérin (BCG) vaccine reduces overall neonatal and infant mortality. However, no study has examined how BCG affects growth. We investigated the effect on infant growth of early BCG vaccine given to low-birth-weight (LBW) infants.
  
  
  METHODS
  Two-thousand three hundred forty-three LBW infants were randomly allocated 1:1 to "early BCG" (intervention group) or "late BCG" (current practice). Furthermore, a subgroup (N = 1717) were included in a two-by-two randomised trial in which they were additionally randomised 1:1 to vitamin A supplementation (VAS) or placebo. Anthropometric measurements were obtained 2, 6, and 12 months after enrolment.
  
  
  RESULTS
  Overall there was no effect of early BCG on growth in the first year of life. The effect of early BCG on weight and mid-upper-arm circumference at 2 months tended to be beneficial among girls but not among boys (interaction between "early BCG" and sex: weight p = 0.03 and MUAC p = 0.04). This beneficial effect among girls was particularly seen among the largest infants weighing 2.0 kg or more at inclusion.
  
  
  CONCLUSIONS
  Though BCG vaccination is not recommended to be given to LBW infants at birth in Guinea-Bissau, early BCG had no negative effect on infant growth and may have had a beneficial effect for girls.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT00146302).
authors.affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.|Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. s.biering@bandim.org.
authors.forename: Sofie
authors.initials: S
authors.lastname: Biering-Sørensen
authors.affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. a.andersen@bandim.org.
authors.forename: Andreas
authors.initials: A
authors.lastname: Andersen
authors.affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. hjn@ssi.dk.|Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, DK-5000, Odense C, Denmark. hjn@ssi.dk.
authors.forename: Henrik
authors.initials: H
authors.lastname: Ravn
authors.affiliation: Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. ivan130978@gmail.com.
authors.forename: Ivan
authors.initials: I
authors.lastname: Monterio
authors.affiliation: Projécto de Saúde Bandim, INDEPTH Network, Codex 1004, Bissau, Guinea-Bissau. p.aaby@bandim.org.
authors.forename: Peter
authors.initials: P
authors.lastname: Aaby
authors.affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. cb@ssi.dk.|Odense Patient data Explorative Network, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, DK-5000, Odense C, Denmark. cb@ssi.dk.
authors.forename: Christine Stabell
authors.initials: CS
authors.lastname: Benn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000886:Anthropometry; D001500:BCG Vaccine / Q000008:administration & dosage*; D001835:Body Weight; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007223:Infant; D007230:Infant, Low Birth Weight / Q000254:growth & development*; D007231:Infant, Newborn; D008297:Male; D012737:Sex Factors; D014801:Vitamin A / Q000008:administration & dosage; D014815:Vitamins / Q000008:administration & dosage
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D014815:Vitamins; D014801:Vitamin A