To investigate the clinical efficacy and safety of caffeine citrate combined with duo positive airway pressure (DuoPAP) in treatment of premature infants with respiratory distress syndrome (RDS).

From January 2016 to November 2017, a total of 90 preterm infants with RDS (28 weeks ≤gestational age <32 weeks) who were hospitalized in the Affiliated Xuzhou Hospital of Southeast University, were chosen as research subjects. They were randomly divided into two groups by random number table method. In the combined treatment group (n=47), they were given caffeine citrate combined with DuoPAP; and in the control group (n=43), they were given DuoPAP without caffeine citrate. The general clinical data, results of blood gas analysis and indicators of respiratory function at 0 h, 24 h and 48 h of breath support therapy, clinical efficacy, related complications of breath support therapy and adverse drug reactions between two groups of premature infants were compared statistically by independent-samples t test, chi-square test and Kruskal-Wallis H rank sum test. The study was reviewed and approved by the Medical Ethics Committee of the Affiliated Xuzhou Hospital of Southeast University (Approval Number: 2015 No. 32), and the informed consents were signed by all the guardians of preterm infants.

① There were no significant differences between two groups in general clinical data including the proportion of male, gravidity, gestational age, birth weight, 1 min and 5 min Apgar scores after birth of RDS premature infants; and the rate of premature rupture of membranes, cesarean section rate, glucocorticoid application rate within 24 h to 7 d before delivery, the incidence rate of hypertensive disorders complicating pregnancy of mother (P>0.05). ② There were no significant differences between two groups of RDS premature infants in pH value, partial pressure of arterial carbon dioxide (PaCO₂), partial pressure of arterial oxygen (PaO₂) and PaO₂/fraction of inspired oxygen (P/F) at 0 h of breath support therapy, also pH value at 24 h, 48 h after breath support therapy (P>0.05). The PaO₂ and P/F of RDS premature infants in combined treatment group at 24 h, 48 h after breath support therapy were higher than those in control group, while PaCO₂ were lower than that in control group, and the differences were statistically significant (24 h: t=3.431, P=0.017; t=3.451, P=0.047; t=-4.241, P=0.008. 48 h: t=3.238, P=0.048; t=3.576, P=0.009; t=-3.527, P=0.031). ③ The duration of DuoPAP ventilation therapy and total oxygen inhaling, the days of hospitalization, the times of apnea, the failure rate of withdrew from the machine, the usage rate of one dose of pulmonary surfactant (PS) in combined treatment group were 3.0 d (1.0-14.0 d), 7.5 d (4.0-21.0 d), 16.0 d (6.0-28.0 d), 10.0 h(7.0-14.0), 8.5% and 21.3%, which were significant shorter, or less, or lower than those in control group, which were 5.5 d (2.0-18.0 d), 11.5 d (6.0-32.0 d), 21.0 d (7.0-35.0 d), 24.0 (18.0-28.0), 25.6% and 41.9%, and all the differences were statistically significant (Z=-2.030, P=0.012; Z=-2.129, P=0.011; Z=-2.889, P=0.009; Z=-2.105, P=0.018; χ²=4.712, P=0.030; χ²=4.439, P=0.035). ④ There were no significant differences between two groups of RDS premature infants in related complication of breath support therapy including air leak syndrome, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), periventricular-intraventricular hemorrhage (PVH-IVH) and neonatal necrotic enterocolitis (NEC), also caffeine associated adverse reactions including incidence rate of feeding intolerance and heart rate abnormal (P>0.05).

Caffeine citrate combined with DuoPAP treatment strategy to premature infants with RDS can effectively improve oxygenation, reduce CO₂ retention, shorten the duration of noninvasive mechanical ventilation and total oxygen inhaling, increase the success rate of machine withdrawal. It is safe and effective.