The CHAIN Cohort

The initial core activity of the CHAIN Network is to establish a large multi-site cohort study of hospitalized children under 2 years old, and to follow these children for 6 months after they are discharged. This cohort study aims to better understand the biological and social reasons that cause malnourished acutely ill children to die at such high rates during and after hospitalization. The findings of this cohort will be strengthen by a range of specialist sub-studies. The CHAIN Network will use this information to prioritize and guide the design of future clinical trials that will help reduce mortality in these vulnerable children.

Four thousand eight hundred children will be recruited at admission to hospital across eight sites (link to sites & teams). We will follow these children from admission and then daily throughout their hospital stay, and then will be followed up at 45, 90 and 180 days after their discharge. An additional 100 children living in the community will be recruited to participate at each site. These community controls will help establish reference norms for various laboratory tests which currently lack accepted normal threshold values.

Allied Trials

Investigators from the CHAIN Network are also involved in a number of on-going clinical trials that will contribute to the Network’s overarching goals. The results obtained from these trials will be used to prioritize future clinical trials. Two particularly relevant ongoing clinical trials are:

•  The FLACSAM trial, which is testing the efficacy of novel antibiotic regimens in children admitted to hospital with severe acute malnutrition, and
•  The Toto Bora trial which is assessing the benefits of a short course of azithromycin to reduce mortality among children after they are discharged from hospital.

Analysis of Pre-Existing Samples

In order to expedite the scientific process, The CHAIN Network aims to capitalize on pre-existing biological samples that have been collected in the context of two recently completed clinical trials. The first trial was designed to assessed the prophylaxis use of co-trimoxazole antibiotic given post-discharge as method of reducing mortality among children with severe acute malnutrition after they are discharged from hospital. Results from this trial were recently published in the Lancet Global Health. The second was the F-75 clinical trial conducted to test a novel macro nutrient formulation of F-75, the feed given to children with severe malnutrition during acute illness. [link to].

Analyzing these pre-existing samples will help The CHAIN Network to rapidly test key hypotheses which will guide the prioritization of interventions to reduce inpatient and post-discharge mortality.