Keszler 2004a.
Methods | Single‐centre randomised trial. | |
Participants | 18 infants. Inclusion criteria: < 34 weeks' GA, ventilated for RDS before 6 h of age. Exclusion criteria: congenital cardiac, respiratory or CNS anomalies, paralysis or sedation or ETT leak > 30%. |
|
Interventions | Ventilator: both groups used Drager Babylog 8000 plus with set backup rate 40/min. Target: PaCO2 of 35‐45 torr (mmHg).
Duration of intervention: 72 h or until extubation. |
|
Outcomes | Blood gas results, pneumothorax, PIE, mortality, cranial ultrasound scan. | |
Supplemental data | BW, age of death in non‐survivors, BPD, duration of ventilation, pneumothorax, PIE, PVL, IVH, blood gas data. | |
Notes | Requested trial registration. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table used to randomise participants. |
Allocation concealment (selection bias) | Low risk | Blinding of randomisation: sealed 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. |
Selective reporting (reporting bias) | Unclear risk | Study protocol unavailable for review. |
Other bias | Low risk |