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Inhaled nitric oxide for premature infants with severe respiratory failure. N Engl J Med 2005 Jul 07;353(1):13-22

Date

07/08/2005

Pubmed ID

16000352

DOI

10.1056/NEJMoa043927

Abstract

BACKGROUND: Inhaled nitric oxide is a controversial treatment for premature infants with severe respiratory failure. We conducted a multicenter, randomized, blinded, controlled trial to determine whether inhaled nitric oxide reduced the rate of death or bronchopulmonary dysplasia in such infants.

METHODS: We randomly assigned 420 neonates, born at less than 34 weeks of gestation, with a birth weight of 401 to 1500 g, and with respiratory failure more than four hours after treatment with surfactant to receive placebo (simulated flow) or inhaled nitric oxide (5 to 10 ppm). Infants with a response (an increase in the partial pressure of arterial oxygen of more than 10 mm Hg) were weaned according to protocol. Treatment with study gas was discontinued in infants who did not have a response.

RESULTS: The rate of death or bronchopulmonary dysplasia was 80 percent in the nitric oxide group, as compared with 82 percent in the placebo group (relative risk, 0.97; 95 percent confidence interval, 0.86 to 1.06; P=0.52), and the rate of bronchopulmonary dysplasia was 60 percent versus 68 percent (relative risk, 0.90; 95 percent confidence interval, 0.75 to 1.08; P=0.26). There were no significant differences in the rates of severe intracranial hemorrhage or periventricular leukomalacia. Post hoc analyses suggest that rates of death and bronchopulmonary dysplasia are reduced for infants with a birth weight greater than 1000 g, whereas infants weighing 1000 g or less who are treated with inhaled nitric oxide have higher mortality and increased rates of severe intracranial hemorrhage.

CONCLUSIONS: The use of inhaled nitric oxide in critically ill premature infants weighing less than 1500 g does not decrease the rates of death or bronchopulmonary dysplasia. Further trials are required to determine whether inhaled nitric oxide benefits infants with a birth weight of 1000 g or more.

Author List

Van Meurs KP, Wright LL, Ehrenkranz RA, Lemons JA, Ball MB, Poole WK, Perritt R, Higgins RD, Oh W, Hudak ML, Laptook AR, Shankaran S, Finer NN, Carlo WA, Kennedy KA, Fridriksson JH, Steinhorn RH, Sokol GM, Konduri GG, Aschner JL, Stoll BJ, D'Angio CT, Stevenson DK, Preemie Inhaled Nitric Oxide Study

Author

Girija Ganesh Konduri MD Chief, Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Administration, Inhalation
Bronchopulmonary Dysplasia
Cerebral Hemorrhage
Combined Modality Therapy
Female
Humans
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases
Infant, Very Low Birth Weight
Leukomalacia, Periventricular
Male
Nitric Oxide
Oxygen
Respiration, Artificial
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Single-Blind Method
Treatment Outcome
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a