Evaluation of the uptake and impact of neonatal Vitamin A supplementation delivered through the Lady Health Worker programme on neonatal and infant morbidity and mortality in rural Pakistan: An effectiveness trial

Background Despite evidence for the benefits of Vitamin A supplementation (VAS) among children 6 to 59months of age, the feasibility of introduction and potential benefit of VAS in the neonatal period in public health programmes is uncertain. Objective The primary objective was to evaluate the feasibility and effectiveness of early neonatal VAS (single dose of 50000 international units within 48-72hours after birth) delivered through the public sector Lady Health Worker (LHW) programme in rural Pakistan and to document its association with a reduction in mortality at 6months of age. Methods A community-based, cluster randomised, placebo-controlled trial was undertaken in two districts of rural Pakistan. LHWs dispensed Vitamin A/placebo in identical capsules to newborn infants within 48-72hours of birth. Follow-up visits were undertaken at 1week of age and every 4weeks thereafter until 6months of age. Results Of a total of 15433 consecutive pregnancies among eligible women of reproductive age, 13225 pregnancies were registered, 12218 live births identified and 11028 newborn infants reached by LHWs. Of these, 5380 (49%) received neonatal VAS and 5648 (51%) placebo. The LHWs successfully delivered the capsules to 79% of newborns within 72hours of birth with no significant adverse effects. Although the proportion of days observed with symptoms of fever, diarrhoea or rapid breathing were lower with neonatal VAS, these differences were not statistically significant. Mortality rates in the two groups were comparable at 6 months of age. Conclusions While our study demonstrated that neonatal VAS was safe and could be feasibly delivered by LHWs in Pakistan as part of their early postnatal visits, the overall lack of benefit on neonatal and 6-month morbidity and mortality in our population suggests the need for further evaluation of this intervention in populations at risk.