Rettwitz‐Volk 1998.
| Methods | Multicentre (3) randomised controlled trial | |
| Participants |
Inclusion criteria: ‐ birth weight 750 to 1500 g ‐ respiratory distress syndrome Exclusion criteria: congenital anomalies; hydrops fetalis Stratification: by birth weight (750 to 1000 g, 1001 to 1500 g) 96 infants enrolled and analysed Mean gestational age: 28.5 ± 0.9 wk in HFOV, 28.4 ± 0.95 wk in CV Mean birth weight: 1107 ± 112 g in HFOV, 1111 ± 116 g in CV Antenatal corticosteroids: 24% in HFOV, 18% in CV Mean age at randomisation: 1.16 ± 0.50 hrs in HFOV, 0.66 ± 0.33 hrs in CV |
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| Interventions |
HFOV: OSC using Stephan SHF 3000 piston oscillator. Settings: initial MAP and amplitude to show good chest movements, 15 to 20 Hz, I:E ratio 1:1 HVS: no. Weaning of MAP first CV: IMV using Stephan HF 300 or Dräger Babylog 8000. Synchronisation: not reported. Settings: PIP to show good chest expansion, IT 0.25 to 0.45 sec, I:E at least = 1:2, PEEP 3 to 4 cm H2O LPS: no Target PCO2: 35 to 48 mmHg Duration of assigned treatment: until extubation or allowed switched to CV if FiO2 < 0.30 and MAP 3 to 4 cm H2O Cross‐over: allowed if infant meets failure criteria (inadequate oxygenation of ventilation with assigned mode; for patients on CV: development of PIE) |
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| Outcomes | Mortality before discharge, CLD (O2 at 37 weeks PMA), failure of assigned treatment (PaO2 < 45 mmHg or PaCO2 > 60 mmHg), pulmonary ALS ± pneumothorax, IVH, PVL | |
| Notes | Surfactant: bovine surfactant (Survanta) was administered after randomisation when chest x‐ray showed RDS grade II and FiO2 > 0.60 was necessary to achieve PO2 > 50 mmHg Cross‐over: 17% in HFOV, 18% in CV Postnatal corticosteroids: 43% in HFOV, 60% in CV (all patients still on oxygen therapy at 7 days of age received a 21 day course of dexamethasone) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "balanced block randomization scheme" |
| Allocation concealment (selection bias) | Unclear risk | No information on procedures to conceal allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible for care‐givers and not relevant for patients |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment was not relevant for most outcomes (death, oxygen dependency). No information on assessment of head ultrasound or chest x‐ray |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up for primary endpoint |