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. 2016 Sep 1;2016(9):CD000456. doi: 10.1002/14651858.CD000456.pub5

Erdemir 2014.

Study characteristics
Methods Randomised
Single centre trial
Sealed envelope randomisation
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%
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
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