Lista 2009.
Methods | Study design: randomized controlled prospective clinical trial Setting: single‐center study in Milan, Italy Duration of study: 2007‐2008 |
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Participants | Inclusion criteria: infants from 28‐34 weeks' gestational age with moderate RDS, defined in the first hour of life as PO2 ratio of 0.3‐0.35 and signs on chest x‐ray Exclusion criteria: infants with lethal congenital anomalies, infants requiring muscle relaxants, severe intraventricular hemorrhage, chorioamnionitis, sepsis, or suspected infection Number randomized: 40 infants total (gender not reported) |
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Interventions | Interventions were performed with the Infant Flow CPAP and Infant Flow SiPAP ventilators (Viasys Health Care, Conshohocken, PA, USA) via binasal prongs. NCPAP (n = 20) was administered at 6 cmH2O, and NIPPV (n = 20) at a lower CPAP level of 4.5 cmH2O and an upper CPAP level of 8 cmH2O with an initial rate of 30 breaths per minute. NIPPV was synchronized. | |
Outcomes | Primary outcome: cytokine levels (IL‐6, IL‐8, and TNF‐alpha) Secondary outcomes: heart rate, systemic blood pressure, oxygen saturation, arterial blood gases, length of ventilation (total duration of respiratory support), PDA, need for treatment with ibuprofen or surfactant, incidence of air leaks, severe IVH, oxygen dependency at day 28 and/or at 36 weeks' postconceptional age, survival |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers with stratified randomization for gestational age |
Allocation concealment (selection bias) | Low risk | Random number (representing allocation) was disclosed during phone call after enrollment in the trial. |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding was impossible owing to the nature of the interventions. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study authors reported no incomplete outcome data. |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes reported in the published article corresponded with outcomes listed in the original protocol. Information provided by study authors |
Other bias | Unclear risk | Unclear from the information provided |