Health Problem: Respiratory distress syndrome (RDS) is one of the most common causes of preterm infant respiratory failure and mortality, with RDS occurring in 20,000 to 30,000 newborn infants annually in the United States. RDS results from developmental immaturity of the lungs, which leads to insufficient surfactant production and function. Bronchopulmonary dysplasia (BPD) is a long-term pulmonary complication of RDS in preterm newborns and is associated with prolonged hospitalization and lasting pulmonary and neurodevelopmental problems. BPD occurs in 10,000 to 15,000 newborns each year in the United States.
Technology Description: Inhaled nitric oxide (iNO) therapy increases the partial pressure of arterial oxygen by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion ratios toward regions with normal ratios. iNO therapy is proposed to reduce mortality and prevent early lung injury in ventilated preterm newborns with hypoxic respiratory failure.
Controversy: Rapid growth of off-label use of iNO in preterm infants continues, despite a lack of evidence suggesting improvements in survival or pulmonary and neurodevelopmental outcomes. The safety and effectiveness of the use of iNO therapy in preterm infants < 35 weeks of gestation requires further consideration.
Key Questions:
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Does iNO treatment reduce mortality or prevent the development of BPD?
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Does iNO treatment improve neurodevelopmental outcomes?
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Is iNO therapy safe?
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Have definitive patient selection criteria been identified for iNO?
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