Vitamin A supplementation and BCG vaccination at birth in low birthweight neonates: two by two factorial randomised controlled trial

Study answer

What this study found

Vitamin A supplementation at birth did not reduce overall infant mortality: mortality rate ratio 1.08 (95% CI 0.79-1.47) after adjusting for early BCG; No interaction with BCG (P=0.73). Sex-specific effects showed a trend toward benefit in boys (MRR 0.74, 95% CI 0.45-1.22) and potential harm in girls (MRR 1.42, 95% CI 0.94-2.15). When combined with the complementary trial in normal birthweight neonates, overall mortality ratio 1.08 (95% CI 0.86-1.34) with a significant sex interaction (P=0.01): boys ~0.80 (0.58-1.10); girls ~1.41 (1.04-1.90). Conclusion: Implementing neonatal vitamin A…

Study & population

Design: Randomised, placebo-controlled, two-by-two factorial trial conducted in Bissau, Guinea-Bissau.

Intervention

One-time oral dose of vitamin A: 25,000 IU retinyl palmitate in 0.5 ml oil, given at birth.

Key limitation

Cause of death determined by verbal autopsy with broad categories; multiple subgroup analyses raise risk of spurious findings; not all vaccinations followed standard sequences; variation in vaccination timing and records; generalizability may be limited to similar settings.

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Original abstract