A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS

Objective: To compare the requirement for endotracheal ventilation in preterm infants treated with heated, humidified high-flow nasal cannula (HHHFNC) with those treated with nasal intermittent positive pressure ventilation (NIPPV) for the primary treatment of respiratory distress syndrome (RDS).

Study design: Randomized, controlled, prospective, single-center pilot study. Infants (gestational age [GA] <35 weeks, birth weight [BW] >1,000 g) with RDS were randomly assigned to receive HHHFNC (38 infants) delivered by Vapotherm® device (Precision Flow™ or 2000 i, Vapotherm Inc., Stevensville, MD), at flows between 1.0 and 5.0 L/min, or NIPPV (38 infants) delivered by the SLE 2000 or 5000. Surfactant was administered as rescue therapy. Analysis was done by intention-to-treat.

Results: Infant's characteristics ([mean ± SD] GA 31.8 ± 2.3 vs. 32.0 ± 2.3 weeks) and cardio-respiratory status at study entry (FiO2 0.25 ± 0.05 vs. 0.26 ± 0.07; SpO2 90 ± 6% vs. 87 ± 12; PCO2 54.4 ± 10.4 vs. 52.6 ± 8.0 mmHg) were comparable for the HHHFNC and NIPPV groups. There was no significant difference in the need for endotracheal ventilation (28.9% vs. 34.2%) between HHHFNC and NIPPV groups. One infant failed HHHFNC and succeeded on NIPPV. The rate of neonatal morbidities (pneumothorax, bronchopulmonary dysplasia, intra-ventricular hemorrhage, necrotizing enterocolitis, patent ductus arteriosus, and nasal trauma) was comparable in both groups. Duration of nasal support was longer with HHHFNC compared with NIPPV (5.4 ± 4.0 vs. 2.6 ± 1.9 days, P = 0.006) but the duration of endotracheal ventilation, time to full feeds, and length of stay were comparable.

Conclusions: Our pilot study suggests that HHHFNC maybe as effective as NIPPV in preventing endotracheal ventilation in the primary treatment of RDS in premature infants (<35 weeks GA and BW >1,000 g).