Zinc as an adjunct for the treatment of very severe disease in infants

More than 3 of the 7.6 million global deaths in under 5 years occur in the neonatal period and about 75% in the first week of life. More than 70% of these neonatal deaths occur in Africa and South East Asia. Severe infections like pneumonia and sepsis contribute 25% of the global deaths and are also a major cause of hospitalization in infants. Despite appropriate antimicrobial therapy, the outcomes of these severe infections in early infancy remain poor.

Effective interventions that can be added to standard therapy for severe infections are required to improve clinical outcomes and to reduce case fatality. Oral zinc is a promising intervention in severe childhood illnesses: In a previous study in New Delhi, zinc given in addition to standard therapy reduced the risk of treatment failures in young infants hospitalized with very severe disease. In a randomized double blind placebo controlled trial we will measure to what extent 10 mg of elemental zinc orally daily in infants aged 1 day to 2 months hospitalized with very severe disease, will reduce their risk of death. The intervention (zinc/placebo) will be given till discharge or for maximum 14 days, whichever is earlier.

The study will enrol 4140 infants across 8 centres (5 in India and 3 in Nepal) that have a large burden of young infants with very severe disease, provide care to all sections of society and represent different geographical areas in this region. If this large, multicentre study in South Asia shows that zinc improves treatment outcomes in very severe disease, its use as an adjunct to standard therapy could lead to substantial reductions in infant mortality, particularly in settings where resources are limited and second line antibiotics may not be readily available.