Nair 2005.
Methods | Randomised controlled trial | |
Participants | 67 preterm infants with respiratory distress requiring CPAP in 1st 6 hours, 27 to 34 weeks' gestation (mean 32 weeks) | |
Interventions | HFNC: VapothermTM 5 to 6 L/min; n = 33 CPAP: bubble CPAP, Hudson prongs, 5 to 6 cmH2O; n = 34 |
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Outcomes | Respiratory failure (leading to intubation) (pH ≤ 7.25 and PaCO2 ≥ 60 mmHg , or FiO2 > 0.70, or severe or frequent apnoea); nasal injury; BPD (as defined in Jobe 2001); mortality; length of hospitalisation; sepsis; pneumothorax | |
Notes | Study finished prior to achieving target sample size due to recall of Vapotherm units A full study manuscript including results was obtained from the authors Vapotherm provided equipment for the study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratified into 27 to 30 weeks' and 31 to 34 weeks' gestation. Permuted block randomisation |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) Need for intubation | Unclear risk | Standardised criteria for respiratory failure, though frequency of blood gases and recording of apnoea not blinded |
Blinding (performance bias and detection bias) Nasal damage | High risk | Assessment of nasal injury non‐blinded |
Selective reporting (reporting bias) | Unclear risk | Not registered |
Other bias | Unclear risk | Vapotherm provided equipment for the study. |