Inhaled Nitric Oxide Treatment Stratification for Neonatal Mortality Risk
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Solution Overview
Problem
Current treatments with inhaled nitric oxide for pre-term neonates at risk of bronchopulmonary dysplasia (BPD) pose an increased risk of mortality in white, male pre-term neonates less than 27 weeks gestational age, while non-white and female pre-term neonates of the same age can safely receive the treatment.
Innovation Solution
Identifying and excluding white, male pre-term neonates less than 27 weeks gestational age from inhaled nitric oxide treatment due to their higher risk of mortality, and administering the treatment to non-white and female pre-term neonates, with alternative treatments provided for white, male neonates based on their specific conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If inhaled nitric oxide is administered to pre-term neonates to prevent BPD, then the incidence of BPD is reduced, but mortality risk increases in white male neonates less than 27 weeks gestational age
Solution Approach 1:
The patent applies local quality by differentiating treatment based on specific neonate characteristics (race, sex, gestational age). White male neonates less than 27 weeks gestational age are identified as a distinct subgroup with higher mortality risk and are excluded from treatment, while other neonates receive the beneficial treatment. This targeted approach allows the treatment to be applied locally to appropriate populations rather than universally.
2Productivity
If inhaled nitric oxide is administered universally to all pre-term neonates at risk of BPD, then BPD prevention is maximized, but overall safety is compromised due to increased mortality in specific subgroups
Solution Approach 1:
The patent segments the pre-term neonate population into distinct subgroups based on race, sex, and gestational age characteristics. By dividing the population into those at higher risk (white males less than 27 weeks) and those at lower risk, the treatment can be selectively applied to maximize productivity (BPD prevention coverage) while maintaining reliability (safety) by excluding the high-risk subgroup.
3Object-affected harmful factors
If inhaled nitric oxide treatment is restricted to exclude white male neonates less than 27 weeks gestational age, then mortality risk is reduced, but BPD prevention coverage is decreased
Solution Approach 1:
The patent converts the harmful effect (increased mortality risk in white male neonates less than 27 weeks) into a beneficial filtering mechanism. By identifying this specific subgroup through demographic criteria, the treatment protocol uses these characteristics to exclude high-risk patients, thereby converting what would be a harmful universal application into a beneficial targeted therapy that protects vulnerable populations while maintaining overall treatment coverage.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Reduces the overall risk of mortality from inhaled nitric oxide treatment by tailoring the administration to specific neonatal populations, ensuring safer treatment protocols for pre-term neonates at risk of BPD.
Implementation Method 1
inhaled nitric oxide (a potent and selective pulmonary vasodilator)
Implementation Method 2
lower pulmonary artery pressure
Data Source
AI summary
Disclosed are methods of treatment that permit a reduction of risk of mortality in infants who are candidates for treatment with inhaled nitric oxide, by identifying a subset of such infants who are at an increased risk of mortality upon treatment with inhaled nitric oxide; also disclosed are related systems for use in administering inhaled nitric oxide and methods of distributing a pharmaceutical product.