Duman 2012.
Methods | Single‐centre randomised trial. | |
Participants | 45 infants. Inclusion criteria: GA < 32 weeks and mechanical ventilation for severe RDS for > 24 h. Exclusion criteria: major congenital anomalies and mechanical ventilation < 24 h. |
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Interventions | Ventilator: both groups used Drager Babylog 8000plus. Initially in SIPPV(AC) mode and then switched to SIMV mode during weaning. Inflation time 0.3‐0.4 sec and PEEP 4‐6 cmH2O. During weaning, respiratory rate was gradually reduced to 18/min. Clear protocol for ventilation and weaning. Target: PaCO2 40‐60 mmHg.
Duration of intervention: until extubation. |
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Outcomes | Primary: duration of ventilation (median and IQR). Other: mortality, BPD, PDA, IVH grade 3 or 4, PVL, pneumothorax. |
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Supplemental data | Duration of ventilation (mean and SD), clarification about the randomisation process and inclusions/exclusions. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation with random block sizes. |
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) | Low risk | Not applicable. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up: complete to end of intervention. Secondary postintervention outcomes reported during period of primary admission. |
Selective reporting (reporting bias) | Unclear risk | No trial registration. |
Other bias | Low risk |