OBJECTIVE: To compare the safety and efficacy of two low expiratory resistance models of nasal continuous positive airway pressure (n-CPAP) in preterm infants. MATERIAL AND METHODS: A 1-year prospective trial was performed in the Neonatal Intensive Care Unit of La Fe Hospital to compare the Infant Flow (IF) and Medijet (MJ) devices. All preterm infants requiring n-CPAP for respiratory distress at birth (group I), infants weighting less than 1500 g requiring postextubation (group II) and those with apnea-bradycardia syndrome (ABS) (group III) were included. The patients were randomly assigned to IF or MJ. RESULTS: A total of 125 patients received 226 treatments (IF: n 5 126: MJ: n 5 110). The mean gestational age was 29.4 weeks and the mean birth weight was 1340 g.Efficacy. In group I (n 5 73) no difference were found between systems and 6 hours' after initiation of n-CPAP decreases in FiO2, CO2 and respiratory effort were similar. The need for intubation was also similar (IF: 34.6 %; MJ: 24.1 %). In group II (n 5 73) the need for reintubation at 48 hours was similar with both treatments (IF:19 %; MJ: 8 %). In group III (n 5 80) resolution of ABS was similar after 24 hours of n-CPAP (IF: 46 %; MJ: 58 %). The need for intubation was also similar (IF: 26 %; MJ: 10 %).Complications. Air leaks occurred in six preterm infants (IF: 4; MJ: 2). Severe abdominal distension occurred in 5 % with both systems. Five infants had significant nasal lesions (IF: 1; MJ: 4). CONCLUSIONS: The efficacy and safety of both systems was similar in the variables studied and no significant differences were found.
RCT Entities:
OBJECTIVE: To compare the safety and efficacy of two low expiratory resistance models of nasal continuous positive airway pressure (n-CPAP) in preterm infants. MATERIAL AND METHODS: A 1-year prospective trial was performed in the Neonatal Intensive Care Unit of La Fe Hospital to compare the Infant Flow (IF) and Medijet (MJ) devices. All preterm infants requiring n-CPAP for respiratory distress at birth (group I), infants weighting less than 1500 g requiring postextubation (group II) and those with apnea-bradycardia syndrome (ABS) (group III) were included. The patients were randomly assigned to IF or MJ. RESULTS: A total of 125 patients received 226 treatments (IF: n 5 126: MJ: n 5 110). The mean gestational age was 29.4 weeks and the mean birth weight was 1340 g.Efficacy. In group I (n 5 73) no difference were found between systems and 6 hours' after initiation of n-CPAP decreases in FiO2, CO2 and respiratory effort were similar. The need for intubation was also similar (IF: 34.6 %; MJ: 24.1 %). In group II (n 5 73) the need for reintubation at 48 hours was similar with both treatments (IF:19 %; MJ: 8 %). In group III (n 5 80) resolution of ABS was similar after 24 hours of n-CPAP (IF: 46 %; MJ: 58 %). The need for intubation was also similar (IF: 26 %; MJ: 10 %).Complications. Air leaks occurred in six preterm infants (IF: 4; MJ: 2). Severe abdominal distension occurred in 5 % with both systems. Five infants had significant nasal lesions (IF: 1; MJ: 4). CONCLUSIONS: The efficacy and safety of both systems was similar in the variables studied and no significant differences were found.