Early Inhaled Nitric Oxide Therapy in Premature Newborns with Respiratory Failure
| Autor: | Richard L. Auten, Thomas N. George, Vinod K. Bhutani, Dale R. Gerstmann, Steven H. Abman, Mark C. Mammel, Gary Cutter, Robert J. Couser, Carl L. Bose, Heather Carriedo, W. Michael Southgate, David C. Hall, Kris C. Sekar, William F. Walsh, Jeffrey S. Gerdes, Monika Baier, Mariann Pappagallo, Claudia Hart, Smeeta Sardesai, John Kinsella, John D. Strain |
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| Rok vydání: | 2006 |
| Předmět: |
Lung Diseases
Male Leukomalacia Periventricular medicine.medical_treatment Nitric Oxide Placebo Administration Inhalation medicine Birth Weight Humans Infant Very Low Birth Weight Bronchopulmonary Dysplasia Mechanical ventilation Respiratory Distress Syndrome Newborn Periventricular leukomalacia business.industry Respiratory disease Infant Newborn Gestational age General Medicine medicine.disease Respiration Artificial Survival Analysis Respiratory failure Bronchopulmonary dysplasia Anesthesia Female business Intracranial Hemorrhages Infant Premature Ventriculomegaly |
| Zdroj: | New England Journal of Medicine. 355:354-364 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa060442 |
| Popis: | The safety and efficacy of early, low-dose, prolonged therapy with inhaled nitric oxide in premature newborns with respiratory failure are uncertain.We performed a multicenter, randomized trial involving 793 newborns who were 34 weeks of gestational age or less and had respiratory failure requiring mechanical ventilation. Newborns were randomly assigned to receive either inhaled nitric oxide (5 ppm) or placebo gas for 21 days or until extubation, with stratification according to birth weight (500 to 749 g, 750 to 999 g, or 1000 to 1250 g). The primary efficacy outcome was a composite of death or bronchopulmonary dysplasia at 36 weeks of postmenstrual age. Secondary safety outcomes included severe intracranial hemorrhage, periventricular leukomalacia, and ventriculomegaly.Overall, there was no significant difference in the incidence of death or bronchopulmonary dysplasia between patients receiving inhaled nitric oxide and those receiving placebo (71.6 percent vs. 75.3 percent, P=0.24). However, for infants with a birth weight between 1000 and 1250 g, as compared with placebo, inhaled nitric oxide therapy reduced the incidence of bronchopulmonary dysplasia (29.8 percent vs. 59.6 percent); for the cohort overall, such treatment reduced the combined end point of intracranial hemorrhage, periventricular leukomalacia, or ventriculomegaly (17.5 percent vs. 23.9 percent, P=0.03) and of periventricular leukomalacia alone (5.2 percent vs. 9.0 percent, P=0.048). Inhaled nitric oxide therapy did not increase the incidence of pulmonary hemorrhage or other adverse events.Among premature newborns with respiratory failure, low-dose inhaled nitric oxide did not reduce the overall incidence of bronchopulmonary dysplasia, except among infants with a birth weight of at least 1000 g, but it did reduce the overall risk of brain injury. (ClinicalTrials.gov number, NCT00006401 [ClinicalTrials.gov].). |
| Databáze: | OpenAIRE |
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