Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn

• Published in: The Journal of pediatrics 1997-07, Vol.131 (1), p.55-62
• Main Authors: Kinsella, John P., Truog, William E., Walsh, William F., Goldberg, Ronald N., Bancalari, Eduardo, Mayock, Dennis E., Redding, Gregory J., deLemos, Robert A., Sardesai, Smeeta, McCurnin, Donald C., Moreland, Susan G., Cutter, Gary R., Abman, Steven H.
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Combined Modality Therapy; Cross-Over Studies; Emergency and intensive care: neonates and children. Prematurity. Sudden death; Extracorporeal Membrane Oxygenation; Female; Hernias, Diaphragmatic, Congenital; High-Frequency Ventilation; Humans; Infant, Newborn; Intensive care medicine; Lung - abnormalities; Male; Meconium Aspiration Syndrome - drug therapy; Meconium Aspiration Syndrome - therapy; Medical sciences; Nitric Oxide - administration & dosage; Nitric Oxide - therapeutic use; Oxygen - blood; Persistent Fetal Circulation Syndrome - drug therapy; Persistent Fetal Circulation Syndrome - therapy; Respiratory Distress Syndrome, Newborn - drug therapy; Respiratory Distress Syndrome, Newborn - therapy; Survival Rate; Treatment Failure; Treatment Outcome
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/S0022-3476(97)70124-0

Background: Although inhaled nitric oxide (iNO) causes selective pulmonary vasodilation and improves oxygenation in newborn infants with persistent pulmonary hypertension, its effects are variable. We hypothesized (1) that the response to iNO therapy is dependent on the primary disease associated with persistent pulmonary hypertension of the newborn (PPHN) and (2) that the combination of high-frequency oscillatory ventilation (HFOV) with iNO would be efficacious in patients for whom either therapy alone had failed. Methods: To determine the relative roles of iNO and HFOV in the treatment of severe PPHN, we enrolled 205 neonates in a randomized, multicenter clinical trial. Patients were stratified by predominant disease category: respiratory distress syndrome ( n = 70), meconium aspiration syndrome ( n = 58), idiopathic PPHN or pulmonary hypoplasia (excluding congenital diaphragmatic hernia) (“other”: n = 43), and congenital diaphragmatic hernia ( n = 34); they were then randomly assigned to treatment with iNO and conventional ventilation or to HFOV without iNO. Treatment failure (partial pressure of arterial oxygen [Pa o 2 ]