The success of this first stage and the low cost of the product, called Lioneo, led to additional financing of R$1.2 million in 2017 from the Ministry of Health and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) for the researcher to continue the project. Since 2018, Simon has led a randomized, controlled, double-blind clinical trial. This type of trial is the most scientifically-sound way to test the acceptance of the lyophilizate and its possible effects on the growth, development and health of babies.
Phase 1, which ended in May 2020, consisted of evaluating 40 newborns weighing less than 1.5 kilos to test the safety and tolerance of the product. After receiving parental consent, the newborns were sorted by random draw into two groups: one that received Lioneo and the other that consumed a commercial additive. Only the nutritionist who prepared the supplement knew what each premature baby was using. The team observed the participants for 21 days, collecting blood at the beginning and end of the period and taking various measurements, including head circumference (around the head), waist circumference, length and daily weight.
After the analysis of the first twenty babies, an external committee of experts in the field evaluated the safety of the experiment for children and issued an opinion authorizing its continuity. Preliminary results, which are not yet published, indicate that Lioneo is safe for premature babies and was well tolerated by them. Among those who consumed the lyophilisate, there was no record of any serious complications. In the group that received the commercial formula, there was a case of necrotizing enterocolitis and a case of late sepsis, an inflammation that spreads through the body due to complications of an infection. “It makes us optimistic for Phase 2,” says Simon.
In the second stage, the researcher will collect the same measurements as in the first phase to identify which of the two groups saw greater increases in the children’s growth. These indicators will allow the researchers to evaluate if Lioneo is not inferior, or even superior, to conventional additives and whether it leads to fewer side effects.
The following step, Phase 3, and for which additional funding is required, will be to increase the number of children in the study, expanding the research to other centers and preparing to produce it on a large scale and at a low cost. “We will assess whether the babies can grow with less protein, especially in length and head circumference, which tends to be healthier and can alter nutrition models for premature babies.” Published in high-impact journals, such as PLoS One and Environmental Research, the production process is already in the public domain. “We decided to do this in order to guarantee access in different countries and economic and social contexts,” says Simon.
