Reply to correspondence letter: Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial
To the Editor,
Thank you for your comments. As pointed out, a difference in the baseline incidence of primary outcome was observed, but it is very difficult to analyze a single cause for it. As such, there was no major change in unit policy for patient management during the study period.
As per Kaplan–Meier survival analysis, mean survival rates of vitamin A and placebo groups were 26.1 and 24.7 days, respectively. The log-rank test failed to detect any statistically significant difference between the groups (χ2 = 2.277; p = 0.131).
The number of deaths within 7 days was 5/98 in vitamin A group compared with 7/98 in placebo, p = 0.767 (NS). Median (IQR) age of death was 6.1 (4.7–11.1) vs. 5.8 (4.5–7.6) days, in vitamin A and placebo groups, respectively, p = 0.713 (NS).
As shown in Table 1, both groups were comparable with regard to a range of maternal and neonatal characteristics. Since there was no difference in early deaths, we do not think non-exposure to vitamin A or a potential unmeasured confounder was responsible for early deaths in any particular group.
We have not considered for adjustment of the primary outcome estimate for the competing risk event (early neonatal death) in our study.
Sixty-seven (67) babies in vitamin A group and 50 babies in the placebo group were discharged before 28 days. We agree that the efficacy and safety of post discharge vitamin A therapy in high-risk neonates need to be studied.