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Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study
Nitya Wadhwa1, Sudha Basnet2, Uma Chandra Mouli Natchu1
1Pediatric Biology Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, India.
Insights
Zinc supplementation may reduce deaths from severe infections in young infants. This trial investigates oral zinc as an adjunct to standard antibiotic therapy to lower infant mortality in developing countries.
Area of Science:
- Pediatrics
- Infectious Diseases
- Public Health
Background:
- Neonatal deaths account for a significant portion of under-5 mortality, with severe infections being a major contributor.
- Mortality from severe infections in developing countries remains high despite antibiotic use.
- There is a critical need for effective interventions to reduce case fatality in infants with severe infections.
Purpose of the Study:
- To evaluate the efficacy of oral zinc as an adjunct to standard therapy in reducing mortality among hospitalized infants with severe infections.
- To investigate the impact of zinc on both hospital and extended case fatality up to 12 weeks post-enrollment.
Main Methods:
- A double-blind, randomized, placebo-controlled superiority trial involving infants aged 3 days to 2 months hospitalized with severe infections.
- Participants were randomized (1:1) to receive either 10 mg of elemental zinc or placebo orally for 14 days, in addition to standard care.
- The study was conducted across seven hospitals in Delhi, India, and Kathmandu, Nepal.
Main Results:
- A previous study indicated zinc reduced treatment failure but had a non-significant effect on case fatality.
- The current study is powered to detect a significant effect on case fatality.
- Results consistent with the previous trial would provide strong evidence for zinc's benefit.
Conclusions:
- If findings align with prior research, this study will support the recommendation of zinc as an adjunctive treatment for severe infections in young infants.
- Effective adjunctive therapies like zinc are crucial for reducing mortality in vulnerable infant populations.
- Further research and clinical trials are essential to confirm the role of zinc in managing severe infections in neonates and young infants.
Background:
An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality.
Methods/Design:
This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment.
Discussion:
A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants.
Trial Registration:
Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.
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