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Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants under 30 weeks gestation: a randomized, controlled trial |
Ramanathan R, Sekar KC, Rasmussen M, Bhatia J, Soll RF |
Journal of Perinatology 2012 May;32(5):336-343 |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To compare the effect of early extubation to nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) on the need for mechanical ventilation via endotracheal tube (MVET) at 7 days of age in preterm infants < 30 weeks' gestation requiring intubation and surfactant for respiratory distress syndrome (RDS) within 60 min of delivery. STUDY DESIGN: Multicenter, randomized, controlled trial. A total of 57 infants were randomized within 120 min of birth to NCPAP (BW 1,099 g and GA 27.8 weeks) and 53 infants to NIPPV (BW 1,052 g, and GA 27.8 weeks). Infants were stabilized on NCPAP at birth and were given poractant alfa combined with MVET within 60 min of age. When stabilized on MVET, they were extubated within the next hours or days to NCPAP or NIPPV. RESULT: A total of 42% (corrected) of infants needed MVET at 7 days of age in the NCPAP group compared with 17% in the NIPPV group (OR 3.6; 95% CI 1.5 to 8.7). Days on MVET were 12 +/- 11 days in NCPAP group compared with 7.5 +/- 12 days in the NIPPV group (median 1 versus 7 days; p = 0.006). Clinical bronchopulmonary dysplasia (BPD) was 39% in the NCPAP group compared to 21% in the NIPPV group (OR 2.4; 95% CI 1.02 to 5.6). Physiological BPD was 46% in the NCPAP group compared with 11% in the NIPPV group (OR 6.6, 95% CI 2.4 to 17.8; p = 0.001). There were no differences in any other outcomes between the two groups. CONCLUSION: NIPPV compared with NCPAP reduced the need for MVET in the first week, duration of MVET, and clinical as well as physiological BPD in preterm infants receiving early surfactant for RDS.
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