Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial

• Published in: Journal of perinatology Vol. 41; no. 1; pp. 32 - 38
• Main Authors: González, Alvaro, Bancalari, Aldo, Osorio, Waldo, Luco, Matías, González, Agustina, Pérez, Héctor, Kattan, Javier
• Format: Journal Article
• Language: English
• Published: United States Nature Publishing Group 01.01.2021
• Subjects: Dosage and administration; Drug therapy; Drug therapy, Combination; Hypertension; Infants; Neonates; Newborn babies; Nitric oxide; Oxygenation; Pediatric research; Pediatric respiratory diseases; Placebos; Pulmonary hypertension; Pulmonary surfactant; Respiratory failure; Respiratory insufficiency; Respiratory insufficiency in children; Surfactants; Chile
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/s41372-020-00777-x

To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40. 100 term newborns with acute HRF (OI ≥ 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use. Baseline mean ± SD OI was 37.4 ± 14 for the Surfactant+iNO group and 38.2 ± 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls, p < 0.05. Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need. ISRCTN13727958.