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

Biering-Sørensen S, Andersen A, Ravn H, Monterio I, Aaby P, Benn CS - BMC Pediatr (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.

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).

No MeSH data available.


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Mentions: A total of 2343 children were invited to participate; of these 23 were excluded (Fig. 1). Hence 2320 children were randomised to early BCG or late BCG at inclusion. At baseline the early BCG and late BCG groups were comparable apart from the early BCG group having more twins/triplets and more mothers who were dead at enrolment [9]. The proportion of children that received OPV at birth were also comparable in the two randomisation groups. At 2 months, 465 children (total 20 %: early BCG:19 %/late BCG:21 %) were not examined anthropometrically, 713 children (total 31 %: early BCG:30 %/ late BCG:32 %) were missing at 6 months and 892 children (total 38 %: early BCG:38 %/late BCG:39 %) were missing at 12 months. The majority of children not examined were travelling or had died, with fewer deaths occurring in the early BCG group compared with the late BCG group (Fig. 1). Among the children seen at 2, 6 and 12 months of age, respectively, there were no baseline differences between the two randomisation groups (Additional file 1). Children never measured for growth at the follow-up visits had a lower weight and length, a smaller head circumference and MUAC as well as mothers with smaller MUAC at inclusion than children measured for growth (Additional file 2). In the intervention group, the median age of BCG vaccination was 2 days (10th–90th percentile: 1–10 days) (Additional file 1). In the control group 58 % had received a BCG vaccine at the 2 months visit [9] and the median age of vaccination was 47 days (20–57 days) (Additional file 1). At 12 months, 81 % of the children in the control group had received BCG [9] and the median age of vaccination was 49 days (22–99) (Additional file 1).Fig. 1


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

Biering-Sørensen S, Andersen A, Ravn H, Monterio I, Aaby P, Benn CS - BMC Pediatr (2015)

Flowchart
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4587923&req=5

Fig1: Flowchart
Mentions: A total of 2343 children were invited to participate; of these 23 were excluded (Fig. 1). Hence 2320 children were randomised to early BCG or late BCG at inclusion. At baseline the early BCG and late BCG groups were comparable apart from the early BCG group having more twins/triplets and more mothers who were dead at enrolment [9]. The proportion of children that received OPV at birth were also comparable in the two randomisation groups. At 2 months, 465 children (total 20 %: early BCG:19 %/late BCG:21 %) were not examined anthropometrically, 713 children (total 31 %: early BCG:30 %/ late BCG:32 %) were missing at 6 months and 892 children (total 38 %: early BCG:38 %/late BCG:39 %) were missing at 12 months. The majority of children not examined were travelling or had died, with fewer deaths occurring in the early BCG group compared with the late BCG group (Fig. 1). Among the children seen at 2, 6 and 12 months of age, respectively, there were no baseline differences between the two randomisation groups (Additional file 1). Children never measured for growth at the follow-up visits had a lower weight and length, a smaller head circumference and MUAC as well as mothers with smaller MUAC at inclusion than children measured for growth (Additional file 2). In the intervention group, the median age of BCG vaccination was 2 days (10th–90th percentile: 1–10 days) (Additional file 1). In the control group 58 % had received a BCG vaccine at the 2 months visit [9] and the median age of vaccination was 47 days (20–57 days) (Additional file 1). At 12 months, 81 % of the children in the control group had received BCG [9] and the median age of vaccination was 49 days (22–99) (Additional file 1).Fig. 1

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Research Center for Vitamins & Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen S, Denmark. s.biering@bandim.org.

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).

No MeSH data available.