Singh 2006.
Methods | Dual‐centre randomised trial. | |
Participants | Initially 2 centres, but reduced to one; 109 infants. Inclusion criteria: BW 600‐1500 g, GA 24‐31 weeks with RDS requiring mechanical ventilation. Exclusion criteria: severe congenital malformations. All participants included as intention to treat. Some analyses only performed for participants from main centre. |
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Interventions | Ventilator: both groups used VIP Bird Gold.
Duration of intervention: until infants were recovering from their acute respiratory illness. At that point, the ventilatory mode was changed to SIMV with pressure support ("weaning mode") for participants in both groups. |
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Outcomes | Primary outcome criteria: time from entry into the study until achievement of either AaDO2 < 13 kPa for > 12 h or MAP < 8.0 cmH2O for > 12 h. Other: total duration of mechanical ventilation, duration of MV + CPAP, survival to discharge, frequency of complications: BPD (36 weeks), IVH, PVL, PDA (requiring treatment), NEC (Bell grade ≥ 2), FiO2 (data from Swamy 2008). Follow‐up (Singh 2009): need for home oxygen, cough, wheeze, inhaler use, rate of hospital readmission, rate of respiratory readmission, neurodisability (cerebral palsy, deaf, behavioural problems, blindness) by questionnaire. |
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Supplemental data | BW, age of death in non‐survivors, BPD, duration of ventilation, pneumothorax, PIE, PVL, IVH, PDA. | |
Notes | 109 infants enrolled in Singh 2006, of whom 94 survived to discharge. 3 infants died post‐discharge. Follow‐up studies: Singh 2009: 85/91 (93%) infants eligible for follow‐up assessed at median of 22 months' corrected age; 45 in VTV group and 40 in PLV group (Singh 2009). Reported on pulmonary morbidities and gross neurodevelopmental outcomes and mortality Swamy 2008: reported on respiratory parameters |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random block randomisation. Stratified by BW. |
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 | Blinding of outcome measurements to discharge: no. Investigators involved in long‐term follow‐up were blinded to original treatment modality. |
Intervention bias (strict vs hybrid studies) | Low risk | Not applicable. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up: complete to discharge. 85/91 (93%) infants eligible for follow‐up were assessed at a median of 22 months' corrected age. |
Selective reporting (reporting bias) | Unclear risk | Study protocol unavailable for review. |
Other bias | Unclear risk | Both arms weaned using PLV mode. |