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Randomized trial of nasal synchronized intermittent mandatory ventilation compared with continuous positive airway pressure after extubation of very low birth weight infants
Barrington KJ, Bull D, Finer NN
Pediatrics 2001 Apr;107(4):638-641
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; 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 determine whether noninvasive, nasal synchronized intermittent mandatory ventilation (nSIMV) improves the likelihood that very low birth weight infants will be successfully extubated. METHODS: Infants of < 1,251 g birth weight who were due to be extubated before 6 weeks of age were eligible once they were receiving < 35% oxygen and were on a ventilator rate of < 18 breaths per minute (bpm). Extubation was performed following intravenous loading with aminophylline, after a successful trial of 12 hours of endotracheal synchronized intermittent mandatory ventilation at a rate of 8. Infants were randomized to either nasal continuous positive airway pressure (nCPAP) at 6 cmH2O or nSIMV after extubation. nSIMV was commenced at a rate of 12 bpm with pressure on the ventilator set to achieve a delivered pressure of at least 12 cmH2O and a peak end expiratory pressure of 6 cmH2O. Continuous recording for diagnosis of apnea was performed for 72 hours after extubation. Objective criteria for failure of extubation were as follows: a PaCO2 > 70; FIO2 > 0.7; or severe recurrent apnea (> 2 apneas requiring intermittent positive-pressure ventilation in 24 hours or > 6 apneas > 20 seconds per day). The study ended after 72 hours postextubation or when infants satisfied failure criteria. A sample size of 54 was determined by power analysis. RESULTS: Mean birth weight (831 standard deviation (SD) 193 g) and gestation (26.3 SD 1.8 weeks) did not differ between groups. Mean age at extubation was 7.6 (SD 9.7) days, range 1 to 40 days. The nSIMV group had a lower incidence of failed extubation 4/27 compared with the continuous positive airway pressure group, 12/27. This was attributable to both a decreased incidence of apnea and a decreased incidence of hypercarbia. There was no increase in the incidence of abdominal distension or feeding intolerance. DISCUSSION: nSIMV is effective in preventing extubation failure in very low birth weight infants in the first 72 hours after extubation. Noninvasive ventilation may have other roles in the care of the very low birth weight infant.
Reproduced with permission from Pediatrics. Copyright by the American Academy of Pediatrics.

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