OBJECTIVE: To assess the efficacy and safety of heated humidified high-flow nasal cannula (HHHFNC) ventilation compared with nasal continuous positive airway pressure (NCPAP) on prevention of extubation failure in the NICUs. METHOD: A prospective randomized, controlled un-blinded study was conducted in 12 tertiary hospitals in Hebei Province from December 1, 2012 to May 31, 2013. Neonates were eligible for this study if they were admitted to the participating NICUs within 7 days of postnatal age, and needed noninvasive respiratory support after a period of mechanical ventilation with an endotracheal tube. Infants were randomly assigned to either HHHFNC or NCPAP group. The primary outcome measures included: the incidence of extubation failure, bronchopulmonary dysplasia and the mortality before discharge. RESULT: Among the 255 cases included, 128 were in the HHHFNC group, and 127 were in the NCPAP group. There was no significant difference in gestational age, birth weight, and age at randomization, and male/female ratio between the two groups (P > 0.05). There were no significant differences between groups for days on ventilation, noninvasive respiratory support, oxygen requirement, hospital stay and time to full oral feedings (P > 0.05). The overall mortality of the studied population was 10.6% (27/255) . The occurrence of extubation failure within 7 days was 9.4% whereas 29.0% in very low birth weight infants. There was no significant difference in the extubation failure for HHHFNC (12/128, 9.4%) versus NCPAP (12/127, 9.4%) (P > 0.05), or in mortality for HHHFNC (12/128, 9.4%) versus NCPAP (15/127, 11.8%) (P > 0.05). No significant difference was found between the study groups in the occurrence of bronchopulmonary dysplasia (BPD) and most of severe adverse outcomes analyzed, including air leak syndrome and nasal trauma. The occurrence of abdominal distention during treatment was higher in NCPAP than HHHFNC group (12.6% vs. 5.5%, P < 0.05). CONCLUSION: Among infants ≤ 7 d of postnatal age, HHHFNC appears to have efficacy and safety similar to those of NCPAP group when applied immediately post-extubation to prevent extubation failure. Despite concerns on unmonitored pressure delivery during HHHFNC support, no increase of the occurrence of BPD, air leak syndrome or mortality was found.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of heated humidified high-flow nasal cannula (HHHFNC) ventilation compared with nasal continuous positive airway pressure (NCPAP) on prevention of extubation failure in the NICUs. METHOD: A prospective randomized, controlled un-blinded study was conducted in 12 tertiary hospitals in Hebei Province from December 1, 2012 to May 31, 2013. Neonates were eligible for this study if they were admitted to the participating NICUs within 7 days of postnatal age, and needed noninvasive respiratory support after a period of mechanical ventilation with an endotracheal tube. Infants were randomly assigned to either HHHFNC or NCPAP group. The primary outcome measures included: the incidence of extubation failure, bronchopulmonary dysplasia and the mortality before discharge. RESULT: Among the 255 cases included, 128 were in the HHHFNC group, and 127 were in the NCPAP group. There was no significant difference in gestational age, birth weight, and age at randomization, and male/female ratio between the two groups (P > 0.05). There were no significant differences between groups for days on ventilation, noninvasive respiratory support, oxygen requirement, hospital stay and time to full oral feedings (P > 0.05). The overall mortality of the studied population was 10.6% (27/255) . The occurrence of extubation failure within 7 days was 9.4% whereas 29.0% in very low birth weight infants. There was no significant difference in the extubation failure for HHHFNC (12/128, 9.4%) versus NCPAP (12/127, 9.4%) (P > 0.05), or in mortality for HHHFNC (12/128, 9.4%) versus NCPAP (15/127, 11.8%) (P > 0.05). No significant difference was found between the study groups in the occurrence of bronchopulmonary dysplasia (BPD) and most of severe adverse outcomes analyzed, including air leak syndrome and nasal trauma. The occurrence of abdominal distention during treatment was higher in NCPAP than HHHFNC group (12.6% vs. 5.5%, P < 0.05). CONCLUSION: Among infants ≤ 7 d of postnatal age, HHHFNC appears to have efficacy and safety similar to those of NCPAP group when applied immediately post-extubation to prevent extubation failure. Despite concerns on unmonitored pressure delivery during HHHFNC support, no increase of the occurrence of BPD, air leak syndrome or mortality was found.