OBJECTIVE: To evaluate the clinical course, respiratory outcomes and markers of inflammation in preterm infants with moderate respiratory distress syndrome (RDS) assigned from birth tonasal continuous positive airway pressure (NCPAP) or bi-level NCPAP. METHODS: A total of 40 infants with a gestational age (GA) of 28-34 weeks (<35 weeks' GA), affected by moderate RDS, were considered eligible and were randomised to NCPAP (group A; n=20, CPAP level=6 cm H(2)O) or to bi-level NCPAP (group B; n=20, lower CPAP level=4.5 cm H(2)O, higher CPAP level=8 cm H(2)O), provided with variable flow devices. Inflammatory response was the primary outcome; serum cytokines were measured on days 1 and 7 of life. Length of ventilation, oxygen dependency, need for intubation and occurrence of air leaks were considered as secondary outcomes. RESULTS: Infants showed similar characteristics at birth (group A vs group B: GA 30.3+/-2 vs 30.2+/-2 weeks, birth weight 1429+/-545 vs 1411+/-560 g) and showed similar serum cytokine levels at all times. Group A underwent longer respiratory support (6.2+/-2 days vs 3.8+/-1 days, p=0.025), longer O(2) dependency (13.8+/-8 days vs 6.5+/-4 days, p=0.027) and was discharged later (GA at discharge 36.7+/-2.5 weeks vs 35.6+/-1.2 weeks, p=0.02). All infants survived. No bronchopulmonary dysplasia (BPD) or neurological disorders occurred. CONCLUSIONS:Bi-level NCPAP was associated with better respiratory outcomes versus NCPAP, and allowed earlier discharge, inducing the same changes in the cytokine levels. It was found to be well tolerated and safe in the study population.
RCT Entities:
OBJECTIVE: To evaluate the clinical course, respiratory outcomes and markers of inflammation in preterm infants with moderate respiratory distress syndrome (RDS) assigned from birth to nasal continuous positive airway pressure (NCPAP) or bi-level NCPAP. METHODS: A total of 40 infants with a gestational age (GA) of 28-34 weeks (<35 weeks' GA), affected by moderate RDS, were considered eligible and were randomised to NCPAP (group A; n=20, CPAP level=6 cm H(2)O) or to bi-level NCPAP (group B; n=20, lower CPAP level=4.5 cm H(2)O, higher CPAP level=8 cm H(2)O), provided with variable flow devices. Inflammatory response was the primary outcome; serum cytokines were measured on days 1 and 7 of life. Length of ventilation, oxygen dependency, need for intubation and occurrence of air leaks were considered as secondary outcomes. RESULTS:Infants showed similar characteristics at birth (group A vs group B: GA 30.3+/-2 vs 30.2+/-2 weeks, birth weight 1429+/-545 vs 1411+/-560 g) and showed similar serum cytokine levels at all times. Group A underwent longer respiratory support (6.2+/-2 days vs 3.8+/-1 days, p=0.025), longer O(2) dependency (13.8+/-8 days vs 6.5+/-4 days, p=0.027) and was discharged later (GA at discharge 36.7+/-2.5 weeks vs 35.6+/-1.2 weeks, p=0.02). All infants survived. No bronchopulmonary dysplasia (BPD) or neurological disorders occurred. CONCLUSIONS: Bi-level NCPAP was associated with better respiratory outcomes versus NCPAP, and allowed earlier discharge, inducing the same changes in the cytokine levels. It was found to be well tolerated and safe in the study population.