Noninvasive Secondary Respiratory Support in Late Preterm and Term Neonate: A Randomized Clinical Trial

Aims: The aim is to evaluate nasal continuous positive airway pressure (NCPAP), nonsynchronized nasal intermittent positive pressure ventilation (NIPPV), and nasal high-frequency oscillatory ventilation (NHFOV), as secondary respiratory support options in late premature and mature neonates. Settings and Design: This randomized controlled trial was conducted in the neonatology department of AUMH. Subjects and Methods: A total of 120 late premature and mature neonates, whose gestational ages ranged from 34 to 41 weeks, and who were admitted with respiratory distress (RD) and intubated, were randomized postextubation into three groups: NCPAP ( n = 40), NIPPV ( n = 40), and NHFOV ( n = 40). Statistical Analysis Used: A comparative analysis was performed among these groups. Results: Both NIPPV and NHFOV exhibited significantly enhanced oxygenation parameters in comparison to NCPAP. The mean values ± standard deviation of the significant parameters for the NCPAP, NIPPV, and NHFOV groups, respectively, are as follows: SpO 2 (93.75 ± 2.07, 95.68 ± 1.80, 94.80 ± 1.91), FIO 2 requirements (37.85 ± 8.41, 31.75 ± 11.97, 33.33% ± 8.87%), PaO 2 /FIO 2 ratio (224.2 ± 69.66, 292.6 ± 90.04, 261.0 ± 59.0), SpO 2 /FIO 2 ratio (262.6 ± 72.37, 334.7 ± 97.04, 300.2 ± 65.60), PaO 2 (79.53 ± 5.88, 83.35 ± 4.58, 82.38 ± 5.09 mmHg), and pH (7.32 ± 0.07, 7.36 ± 0.06, 7.37 ± 0.06), with P < 0.001, <0.001, <0.001, <0.001, 0.004, and 0.003, respectively. The incidence of extubation failure did not demonstrate a statistically significant reduction in the NIPPV ( n = 3) and NHFOV ( n = 4) groups compared to the NCPAP group ( n = 9), P = 0.107. Conclusions: NHFOV is as effective as NIPPV when used for secondary respiratory support for late-premature and mature neonates. These ventilator modes may reduce the risk of reintubation and offer better oxygenation than NCPAP. NHFOV is well tolerated without an increased risk of complications. The protocol has been registered in clinical trial.gov with ID number: NCT07000071 and URL: https://ichgcp.net/clinical-trials-registry/NCT07000071.