Erdemir 2014.
Study characteristics | ||
Methods | Randomised Single centre trial Sealed envelope randomisation |
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Participants | 60 prematurely born infants 30 SIMV 30 gestation < 33 weeks or birth weight < 1500 grams requiring mechanical ventilation for RDS Exclusion criteria: admission after 6 hours of age congenital cardiac, respiratory or CNS malformation congenital metabolic disease congenital pneumonia or sepsis perinatal asphyxia leak around ET tube of < 20% |
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Interventions | Received surfactant placed on PTV, then randomised to SIMV or PSV + VG when FiO₂ < 0.4, RR < 60, PIP 16 cmH₂O, PEEP 4 cmH₂O with adequate blood gases | |
Outcomes | Duration of weaning time to extubation PIP, MAP, Vt, RR at start, during and at end of weaning |
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Notes | 58 recruited, 45 reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Sealed envelope randomisation": sequence generation unclear |
Allocation concealment (selection bias) | Low risk | "Sealed envelope randomisation" |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes reported for all participants |