John P Kinsella1, Gary R Cutter2, Robin H Steinhorn3, Leif D Nelin4, William F Walsh5, Neil N Finer6, Steven H Abman7. 1. Pediatric Heart Lung Center, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, Section of Neonatology, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO. Electronic address: john.kinsella@ucdenver.edu. 2. Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham, AL. 3. University of California-Davis Children's Hospital, Sacramento, CA. 4. Nationwide Children's Hospital, Columbus, OH. 5. Vanderbilt University Medical Center, Nashville, TN. 6. University of California-San Diego, La Jolla, CA. 7. Pediatric Heart Lung Center, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, Section of Pulmonary Medicine, University of Colorado School of Medicine/Children's Hospital Colorado, Aurora, CO.
Abstract
OBJECTIVE: To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation. STUDY DESIGN: We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes. RESULTS: There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P = .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%; P = .89), duration of mechanical ventilation (9.7 vs 8.4 days; P = .27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P = .68). CONCLUSIONS: We 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.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of early, noninvasive inhaled nitric oxide (iNO) therapy in premature newborns who do not require mechanical ventilation. STUDY DESIGN: We performed a multicenter randomized trial including 124 premature newborns who required noninvasive supplemental oxygen within the first 72 hours after birth. Newborns were stratified into 3 different groups by birth weight (500-749, 750-999, 1000-1250 g) prior to randomization to iNO (10 ppm) or placebo gas (controls) until 30 weeks postmenstrual age. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary outcomes included the need for and duration of mechanical ventilation, severity of BPD, and safety outcomes. RESULTS: There was no difference in the incidence of death or BPD in the iNO and placebo groups (42% vs 40%, P = .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%; P = .89), duration of mechanical ventilation (9.7 vs 8.4 days; P = .27), or safety outcomes including severe intracranial hemorrhage (3.4% vs 6.2%, P = .68). CONCLUSIONS: We 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.
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