OBJECTIVE: To determine whether use of the click test, a rapid bedside test of surfactant function, results in earlier and more appropriate surfactant administration in ventilated preterm infants than does usual early rescue treatment. STUDY DESIGN:Ventilated preterm infants (n = 126) with inspired oxygen >/=25% and mean airway pressure >/=7 cm H(2)O were randomized in gestational strata (<28 weeks and 28-36 weeks) to have surfactant therapy determined by the click test or by usual clinical and chest radiograph criteria. The treatment group had the click test performed on a tracheal aspirate as soon as possible after intubation and, if negative or equivocal (surfactant deficient), surfactant was given. The control group had surfactant given as soon as possible based on clinical and chest radiograph diagnoses of respiratory distress syndrome. RESULTS: In infants of <28 weeks' gestation, use of the click test resulted in significantly earlier surfactant therapy (median time: 50 vs 159 minutes) and a reduction in the number of infants receiving surfactant (48% vs 79%). In infants of 28 to 36 weeks' gestation, there was no difference in time to surfactant (median time: 300 vs 268 minutes) or in the number of infants receiving surfactant. Neonatal morbidity and mortality were similar in click test and control groups. CONCLUSIONS: Use of the click test in ventilated, extremely premature infants results in significantly earlier and more appropriately targeted administration of surfactant than does early rescue therapy based on clinical and radiograph criteria. A randomized trial of targeted early rescue surfactant therapy versus prophylactic surfactant therapy in infants of <28 weeks' gestation is warranted. The click test has the potential to improve clinical outcomes and reduce costs.
RCT Entities:
OBJECTIVE: To determine whether use of the click test, a rapid bedside test of surfactant function, results in earlier and more appropriate surfactant administration in ventilated preterm infants than does usual early rescue treatment. STUDY DESIGN: Ventilated preterm infants (n = 126) with inspired oxygen >/=25% and mean airway pressure >/=7 cm H(2)O were randomized in gestational strata (<28 weeks and 28-36 weeks) to have surfactant therapy determined by the click test or by usual clinical and chest radiograph criteria. The treatment group had the click test performed on a tracheal aspirate as soon as possible after intubation and, if negative or equivocal (surfactant deficient), surfactant was given. The control group had surfactant given as soon as possible based on clinical and chest radiograph diagnoses of respiratory distress syndrome. RESULTS: In infants of <28 weeks' gestation, use of the click test resulted in significantly earlier surfactant therapy (median time: 50 vs 159 minutes) and a reduction in the number of infants receiving surfactant (48% vs 79%). In infants of 28 to 36 weeks' gestation, there was no difference in time to surfactant (median time: 300 vs 268 minutes) or in the number of infants receiving surfactant. Neonatal morbidity and mortality were similar in click test and control groups. CONCLUSIONS: Use of the click test in ventilated, extremely premature infants results in significantly earlier and more appropriately targeted administration of surfactant than does early rescue therapy based on clinical and radiograph criteria. A randomized trial of targeted early rescue surfactant therapy versus prophylactic surfactant therapy in infants of <28 weeks' gestation is warranted. The click test has the potential to improve clinical outcomes and reduce costs.