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. 2017 Oct 17;2017(10):CD003666. doi: 10.1002/14651858.CD003666.pub4

Erdemir 2014.

Methods Single‐centre randomised trial.
Participants 60 infants.
Inclusion criteria: GA < 33 weeks or BW < 1500 g (or both); ventilated for RDS.
Exclusion criteria: admission at > 6 h of age; congenital cardiac, respiratory or CNS malformations; congenital metabolic diseases, congenital pneumonia, sepsis, perinatal asphyxia and leak < 20% around the ETT.
Interventions Ventilator: Babylog 8000plus.
All participants initially ventilated using SIPPV (AC) mode (PEEP 4 cmH2O, inflation time 0.4 sec). Intervention started in weaning phase when FiO2 < 0.40, inflation rate < 60/min, PIP 16 cmH2O and PEEP 4 cmH2O with blood gas values within targeted area. Infants then switched to 2 randomised 'weaning modes.'

  • VTV group (n = 30): PSV + VG. Set expired VTtarget 5 mL/kg. Expired VT then reduced during weaning in decrements of 0.5 mL/kg down to expired VT of 3.0 mL/kg. Pmax set 15‐20% above mean PIP needed to achieve target VT. Timax 0.5 sec.

  • PLV group (n = 30): SIMV. PIP 16 cmH2O, PEEP 4 cmH2O, Ti 0.4 sec. Inflation rate weaned stepwise from 40/min.


Duration of intervention: From "start of weaning" until extubation.
Outcomes Primary: "Reduction in ventilator‐associated lung injury."
Other: mortality, BPD, pneumothorax, IVH (any), PDA and duration of ventilation.
Supplemental data  
Notes Initial ventilation with SIPPV, before start of weaning, lasted 7.8 h in PLV group and 4.4 h in VTV group.
Weaning phase lasted 32.4 h in PLV group and 21.1 h in VTV group. Intervention mode consisted of 80% of total duration of ventilation in PLV group and 83% of total duration of ventilation in VTV group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation strategy not described.
Allocation concealment (selection bias) Low risk Blinding of randomisation: sealed opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No.
Intervention bias (strict vs hybrid studies) High risk Hybrid study: different modes of flow termination. In PSV mode, inflation times varies (flow termination). In SIMV, there is a fixed inflation time.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes complete.
Selective reporting (reporting bias) Unclear risk No trial registration available.
Other bias Low risk