Background: The effect of oral polio vaccine administered already at birth (OPV0) on child survival was not\nexamined before being recommended in 1985. Observational data suggested that OPV0 was harmful for boys, and\ntrials have shown that neonatal vitamin A supplementation (NVAS) at birth may be beneficial for boys. We set out\nto test this research question in a randomised trial.\nMethods: The trial was carried out at the Bandim Health Project, Guinea-Bissau. We planned to enrol 900 low-birth\nweight (LBW) boys in a randomised trial to investigate whether NVAS instead of OPV0 could lower infant mortality\nfor LBW boys. At birth, the children were randomised to OPV (usual treatment) or VAS (intervention treatment) and\nfollowed for 6 months for growth and 12 months for survival. Hazard Ratios (HR) for mortality were calculated using\nCox regression. We compared the individual anthropometry measurements to the 2006 WHO growth reference. We\ncompared differences in z-scores by linear regression. Relative risks (RR) of being stunted or underweight were\ncalculated in Poisson regression models with robust standard errors.\nResults: In the rainy season we detected a cluster of deaths in the VAS group and the trial was halted immediately\nwith 232 boys enrolled. The VAS group had significantly higher mortality than the OPV0 group in the rainy season\n(HR: 9.91 (1.23 ââ?¬â?? 80)). All deaths had had contact with the neonatal nursery; of seven VAS boys enrolled during one\nweek in September, six died within two months of age, whereas only one died among the six boys receiving OPV\n(p = 0.05). Growth (weight and arm-circumference) in the VAS group was significantly worse until age 3 months.\nConclusion: VAS at birth instead of OPV was not beneficial for the LBW boys in this study. With the premature\nclosure of the trial it was not possible to answer the research question. However, the results of this study call for\nextra caution when testing the effect of NVAS in the future
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