Gibu 2017.
| Methods | Single centre, randomised controlled cross‐over trial in the USA 2014 to 2016 (in addition to an initial pilot observational study). | |
| Participants |
Inclusion criteria: preterm infants on nasal intermittent mandatory ventilation (NIMV); considered clinically stable by the medical team. Exclusion criteria: congenital airway anomalies; congenital heart disease; neuromuscular disease; feeding intolerance; gastric or oesophageal pathology. |
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| Interventions |
Group 1: NIMV with a cross‐over to NIV‐NAVA. Study repeated the next day starting with NIV‐NAVA with a cross‐over to NIMV. Group 2: NIV‐NAVA with a cross‐over to NIMV. Study repeated the next day starting with NIMV with a cross‐over to NIV‐NAVA. All infants (total n = 7; unclear how many in each group) were on NIMV at the start and finish of the protocol. After set‐up, NIV‐NAVA was applied for up to 30 minutes to determine optimum parameters, followed by at least 30 minutes of NIMV. Infants were then randomised to either continue NIMV or NIV‐NAVA for 3 hours after nursing care and then crossed over to the alternate mode until after the next nursing care. A 2‐hour recording period was used after a 1‐hour washout period following nursing care. |
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| Outcomes |
Primary outcomes: peak inspiratory pressure (PIP); distribution of oxygen saturations; transcutaneous CO₂. Other outcomes: O₂ requirement; frequency of desaturations; length of desaturations; phasic Edi; infant movement; caretaker movement. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. |
| Allocation concealment (selection bias) | Unclear risk | "Infants were randomised". Method not reported. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel unblinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data from 1 infant (13%) not included due to protocol breach. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. |
| Other bias | Low risk | |