CHALLENGE
According to WHO, about 15 million babies are born pre-term each year and one million
die of complications of prematurity. That number is growing.
Prematurity leads the causes of neonatal death and accounts for half of the
cases of neurological impairment in children.
Our challenge has been to explore a new way of measuring gestational age (Round 14- GCE and Round 9 - GCC). "
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NON-INVASIVE
The fragility of the premature neonate is a decisive factor in the choices made in the development of this technology.
ACCURACY
Methods used currently manage a margin of error of about 3 weeks. Our goal is to reduce this margin significantly.
PORTABLE
Ease of handling, transportation and compatibility with the restrictive conditions of premature neonates are determinant in the development requirements of the solution.
LOW COST
The reach of technology is inversely proportional to the cost of implementation. An affordable solution has its potential social impact multiplied.
SOLUTION
Step I: The proof of concept
We found a direct and evolutionary relationship between skin response to light and gestational age.
Stage II: National Multicenter Clinical Trial
The embedded technology in a portable device was called Preemie-Test. It is under evaluation in five Brazilian hospitals, sponsored by the Ministry of Health.
Stage III: International Multicenter Clinical Trial
The Preemie-test will be used experimentally in four centers of excellence in perinatology, two in Brazil, one in Mozambique and another in Portugal. The proposal won the 9th Round of Grand Challenges Canada (2018), with co-sponsorship of Fiocruz.
Step IV: Market entry
At the end of the clinical trials, we hope to offer a new portable, safe, effective and affordable medical device to assess the gestational age of babies born with chronology of dubious or unknown pregnancy.
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Step I
Proof of concept finalized
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Step II
A clinical study on 800 babies
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Step III
A clinical study on 300 babies
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Step IV
Market entry