OBJECTIVES: To assess the safety-efficacy balance of low-dose inhaled nitric oxide (iNO) in hypoxemic premature infants because no sustained beneficial effect has been demonstrated clearly and there are concerns about side effects. STUDY DESIGN:Eight hundred and sixty infants <32 weeks were randomized at birth to receive 5 ppm iNO or placebo when they presented with hypoxemic respiratory failure (HRF) defined by a requirement for mechanical ventilation, fraction of inspired oxygen (FIO 2 ) >40%, and arterio-alveolar ratio in oxygen (aAO 2 ) <0.22. The primary end point was intact survival at 28 days of age. RESULTS:Sixty-one of 415 infants presented with HRF and were compared with 84 of 445 controls who presented with HRF. There was no difference in the primary end point (61.4% in infants [23% with HRF who were treated with iNO] vs 61.1% in controls [21.4% in controls with HRF]; P = .943). For the infants with HRF who were treated with iNO, there was no significant difference from controls for intraventricular hemorrhage (IVH) (6% vs 7%), necrotizing enterocolitis (8% vs 6 %), or patent ductus arteriosus (PDA) (34% vs 37%). Compared with nonhypoxemic infants, the risk of bronchopulmonary displasia (BPD) increased significantly in HRF controls (OR = 3.264 [CI 1.461-7.292]) but not in infants with HRF who were treated with iNO (OR = 1.626 [CI 0.633-4.178]). CONCLUSIONS:iNO appears to be safe in premature infants but did not lead to a significant improvement in intact survival on day 28.
RCT Entities:
OBJECTIVES: To assess the safety-efficacy balance of low-dose inhaled nitric oxide (iNO) in hypoxemic prematureinfants because no sustained beneficial effect has been demonstrated clearly and there are concerns about side effects. STUDY DESIGN: Eight hundred and sixty infants <32 weeks were randomized at birth to receive 5 ppm iNO or placebo when they presented with hypoxemic respiratory failure (HRF) defined by a requirement for mechanical ventilation, fraction of inspired oxygen (FIO 2 ) >40%, and arterio-alveolar ratio in oxygen (aAO 2 ) <0.22. The primary end point was intact survival at 28 days of age. RESULTS: Sixty-one of 415 infants presented with HRF and were compared with 84 of 445 controls who presented with HRF. There was no difference in the primary end point (61.4% in infants [23% with HRF who were treated with iNO] vs 61.1% in controls [21.4% in controls with HRF]; P = .943). For the infants with HRF who were treated with iNO, there was no significant difference from controls for intraventricular hemorrhage (IVH) (6% vs 7%), necrotizing enterocolitis (8% vs 6 %), or patent ductus arteriosus (PDA) (34% vs 37%). Compared with nonhypoxemic infants, the risk of bronchopulmonary displasia (BPD) increased significantly in HRF controls (OR = 3.264 [CI 1.461-7.292]) but not in infants with HRF who were treated with iNO (OR = 1.626 [CI 0.633-4.178]). CONCLUSIONS:iNO appears to be safe in premature infants but did not lead to a significant improvement in intact survival on day 28.
Authors: Lisa M Askie; Roberta A Ballard; Gary R Cutter; Carlo Dani; Diana Elbourne; David Field; Jean-Michel Hascoet; Anna Maria Hibbs; John P Kinsella; Jean-Christophe Mercier; Wade Rich; Michael D Schreiber; Pimol Srisuparp Wongsiridej; Nim V Subhedar; Krisa P Van Meurs; Merryn Voysey; Keith Barrington; Richard A Ehrenkranz; Neil N Finer Journal: Pediatrics Date: 2011-09-19 Impact factor: 7.124
Authors: Kevin R Ellsworth; Marc A Ellsworth; Amy L Weaver; Kristin C Mara; Reese H Clark; William A Carey Journal: JAMA Pediatr Date: 2018-07-02 Impact factor: 16.193
Authors: Michael R Stenger; Jonathan L Slaughter; Kelly Kelleher; Edward G Shepherd; Mark A Klebanoff; Patricia Reagan; Leif D Nelin; William Gardner Journal: Pediatrics Date: 2012-03-12 Impact factor: 7.124
Authors: Lisa M Askie; Roberta A Ballard; Gary Cutter; Carlo Dani; Diana Elbourne; David Field; Jean-Michel Hascoet; Anna Maria Hibbs; John P Kinsella; Jean-Christophe Mercier; Wade Rich; Michael D Schreiber; Pimol Srisuparp; Nim V Subhedar; Krisa P Van Meurs; Merryn Voysey; Keith Barrington; Richard A Ehrenkranz; Neil Finer Journal: BMC Pediatr Date: 2010-03-23 Impact factor: 2.125