Chowdhury 2013.
Methods | Single‐centre randomised trial. | |
Participants | 40 infants. Inclusion criteria: < 34 weeks GA, mechanically ventilated in the first week after birth. Exclusion criteria: major congenital anomalies, ventilated > 24 h or supported by high‐frequency ventilation or both. |
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Interventions | Ventilator: SLE5000 (software 4,3). Both groups: inflation time 0.3‐0.4 sec, inflation rate 40‐60/min, PEEP not reported.
Both groups: predefined weaning strategy; underlying trigger mode changed from SIMV to AC. Duration of intervention: until extubation. |
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Outcomes | Primary: time to reach specified weaning criteria. Other: survival to discharge, BPD at 28 days, IVH grade 3 or 4, cystic PVL, PDA treated (medication/ligation), pneumothorax, postnatal steroids, duration of ventilation, failure of initial ventilation mode, blood gas analyses and work of breathing (assessed by transdiaphragmatic pressure time product). |
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Supplemental data | Mortality, BPD at 36 weeks, detailed blood gas, duration of ventilation presented as mean (SD). | |
Notes | Imbalance with regard to BW, GA and antenatal steroid use despite randomisation. Participants in the PLV group had lower median GA/BW than participants in the VTV group (median GA/BW 26 weeks/856 g vs 28 weeks/1016 g). In the published report, authors adjusted for this difference, but this review used the unadjusted outcomes. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table generation. |
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 | Trial registration submitted after completion of study. |
Other bias | High risk | Despite randomisation, there was imbalance with regard to BW, GA and antenatal steroid use. Participants in the PLV group had lower median GA/BW than participants in the VTV group (median GA/BW 26 weeks/856 g vs 28 weeks/1016 g). |