کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6220119 | 1607448 | 2014 | 6 صفحه PDF | دانلود رایگان |
ObjectiveTo assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation.Study designWe performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72Â hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250Â g) prior to randomization to iNO (10Â ppm) or placebo gas (controls) until 30Â weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36Â weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes.ResultsThere was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, PÂ =Â .86, relative risk = 1.06, 0.7-1.6). BPD severity was not different between the treatment groups. There were no differences between the groups in the need for mechanical ventilation (22% vs 23%; PÂ =Â .89), duration of mechanical ventilation (9.7 vs 8.4Â days; PÂ =Â .27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, PÂ =Â .68).ConclusionsWe found that iNO delivered noninvasively to premature infants who have not progressed to early respiratory failure is a safe treatment, but does not decrease the incidence or severity of BPD, reduce the need for mechanical ventilation, or alter the clinical course.
Journal: The Journal of Pediatrics - Volume 165, Issue 6, December 2014, Pages 1104-1108.e1