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

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.
Interventions Ventilator: both groups used VIP Bird Gold.
  • VTV group (n = 57): volume‐controlled ventilation, inspired VTtarget 4‐6 mL/kg. Pmax setting not described.

  • PLV group (n = 52): PLV. PIP was manually adjusted to target VT 4‐6 mL/kg.


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.
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.
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
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.