Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial

Sofie Biering-Sørensen, Andreas Andersen, Henrik Ravn, Ivan Monterio, Peter Aaby, Christine Stabell Benn, Sofie Biering-Sørensen, Andreas Andersen, Henrik Ravn, Ivan Monterio, Peter Aaby, Christine Stabell Benn

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.

Conclusion: 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.

Trial registration number: ClinicalTrials.gov (NCT00146302).

Figures

Fig. 1
Fig. 1
Flowchart
Fig. 2
Fig. 2
Lowess curves illustrating patters of growth for weight, length, head circumference and mid upper arm circumference (MUAC). The lowess curves are generated for both the early BCG group and the late BCG group together. There is no effect of BCG on the overall estimates why the lines for the two randomization groups could not be drawn separately
Fig. 3
Fig. 3
The effect of early BCG on anthropometric measurements at 2, 6 and 12 months. aAnalyses are conducted using longitudinal linear regression models containing information on the 2, 6 and 12 months measurements in one model. The analyses are furthermore adjusted for the corresponding measurement at enrolment. *Marks significant effect of early BCG (p < 0.05). & Marks significant interaction (p < 0.05) between sex and early BCG

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Source: PubMed

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