Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Proportion of ventilations with VTe between 4-8ml/kg |
percentage of ventilations within range divided through all ventilations performed, for each participant |
through study completion, an average of 1 year |
|
Secondary |
Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations |
defined as > 50% |
through study completion, an average of 1 year |
|
Secondary |
Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube) |
defined as < 4ml/kg |
through study completion, an average of 1 year |
|
Secondary |
Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube) |
defined as > 8ml/kg |
through study completion, an average of 1 year |
|
Secondary |
Mean value for ventilation rate (defined as ventilations per minute) |
defined as ventilations per minute |
through study completion, an average of 1 year |
|
Secondary |
Mean value for peak inflation pressure |
defined as > 35 cmH2O |
through study completion, an average of 1 year |
|
Secondary |
Outcome data and adverse events |
this included diagnoses (i.e., bronchopulmonary dysplasia [BPD], persistent ductus arteriosus [PDA], IVH, periventricular leukomalacia [PVL], and pneumothorax) and the time frame of occurrence (within 24 hours, one week, or during the total hospital stay). BPD was defined as the need of any respiratory support at the GA of 36 weeks, evaluated for infants below 32+0 weeks GA. IVH was determined using the DEGUM classification |
through study completion, an average of 1 year |
|
Secondary |
Comparison of elective versus delivery room interventions |
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison |
through study completion, an average of 1 year |
|
Secondary |
Comparison of fellows vs. consultants |
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison |
through study completion, an average of 1 year |
|
Secondary |
Comparison of sef-inflating-bag vs. neo-T |
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison |
through study completion, an average of 1 year |
|
Secondary |
Comparison of ventilations via face mask vs. endotracheal tube |
mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison |
through study completion, an average of 1 year |
|