Inhaled nitric oxide in premature neonates with severe hypoxaemic respiratory failure: a randomised controlled trial

被引:180
作者
Kinsella, JP
Walsh, WF
Bose, CL
Gerstmann, DR
Labella, JJ
Sardesai, S
Walsh-Sukys, MC
McCaffrey, MJ
Cornfield, DN
Bhutani, VK
Cutter, GR
Baier, M
Abman, SH
机构
[1] Univ Colorado, Sch Med, Childrens Hosp, Div Neonatol, Denver, CO 80218 USA
[2] Vanderbilt Univ, Nashville, TN USA
[3] Univ N Carolina, Chapel Hill, NC USA
[4] Utah Valley Reg Med Ctr, Provo, UT USA
[5] Magee Womens & Childrens Hosp, Pittsburgh, PA USA
[6] Univ So Calif, Los Angeles, CA USA
[7] Case Western Reserve Univ, Cleveland, OH 44106 USA
[8] Reg Naval Med Ctr, San Diego, CA USA
[9] Univ Minnesota, Minneapolis, MN USA
[10] Penn Hosp, Philadelphia, PA 19107 USA
关键词
D O I
10.1016/S0140-6736(99)03558-8
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Inhaled nitric oxide improves oxygenation and lessens the need for extracorporeal-membrane oxygenation in full-term neonates with hypoxaemic respiratory failure and persistent pulmonary hypertension, but potential adverse effects are intracranial haemorrhage and chronic lung disease. We investigated whether low-dose inhaled nitric oxide would improve survival in premature neonates with unresponsive severe hypoxaemic respiratory failure, and would not increase the frequency or severity of intracranial haemorrhage or chronic lung disease. Methods We did a double-blind, randomised controlled trial in 12 perinatal centres that provide tertiary care. 80 premature neonates (gestational age less than or equal to 34 weeks) with severe hypoxaemic respiratory failure were randomly assigned inhaled nitric oxide (n=48) or no nitric oxide (n=32, controls). Our primary outcome was survival to discharge. Analysis was by intention to treat. We studied also the rate and severity of intracranial haemorrhage, pulmonary haemorrhage, duration of ventilation, and chronic lung disease at 36 weeks' postconceptional age. Findings The two groups did not differ for baseline characteristics or severity of disease. Inhaled nitric oxide improved oxygenation after 60 min (p=0.03). Survival at discharge was 52% in the inhaled-nitric-oxide group and 47% in controls (p=0.65). Causes of death were mainly related to extreme prematurity and were similar in the two groups. The two groups did not differ for adverse events or outcomes (intracranial haemorrhage grade 2-4, 28% inhaled nitric oxide and 33% control; pulmonary haemorrhage 13% and 9%; chronic lung disease 60% and 80%). Interpretation Low-dose inhaled nitric oxide improved oxygenation but did not improve survival in severely hypoxaemic premature neonates. Low-dose nitric oxide in the most critically ill premature neonates does not increase the risk of intracranial haemorrhage, and may decrease risk of chronic lung injury.
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页码:1061 / 1065
页数:5
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