Bisceglia 2007.
| Methods | Study design: prospective randomized controlled trial Setting: single‐center trial at San Giovanni Di Dio Hospital in Italy Duration of study: January 2001‐January 2004 |
|
| Participants | Inclusion criteria: infants between 24 and 37 weeks' gestational age with mild to moderate RDS, defined as the need for FiO2 < 0.4 to keep oxygen saturation between 90% and 96%, as well as
a chest x‐ray positive for early hyaline membrane disease Exlusion criteria: pneumothorax, pneumomediastinum, surgical or cardiac disease, intraventricular hemorrhage, major congenital abnormalities Infants were not treated with aminophylline or caffeine. Number randomized: 88 infants total (46 males, 42 females) |
|
| Interventions | Both interventions were performed with use of the Bear Infant Ventilator CUB 750 (Ackrad Laboratories, Cranford, NJ, USA) via silicone binasal prongs (Ginevri, Rome, Italy). NCPAP (n = 46) was administered at 4‐6 cmH2O. NIPPV (n = 42) was administered with PIP 14‐20 cmH2O at 40 breaths per minute and end expiratory pressure 4‐6 cmH2O. NIPPV was nonsynchronized. | |
| Outcomes | Primary outcome: number of infants in each group who needed endotracheal intubation (i.e. failure of nasal ventilatory support) Secondary outcomes: total duration of respiratory support, number of apneic episodes, variation in blood O2 and CO2 partial pressures (evaluated at 4 hours after study enrollment) |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Study authors used EPISTAT, an online statistical program, to generate the sequence of interventions. |
| Allocation concealment (selection bias) | Unclear risk | Investigators concealed the sequence from practitioners before each participant assignment (information obtained upon personal correspondence with study authors). It is unclear, however, which method of concealment was used. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Blinding was impossible owing to the nature of the interventions used. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | Unclear risk | Unclear from information provided |
| Other bias | Unclear risk | Unclear from information provided |