RESPIRATORY MANAGEMENT OF EXTREMELY PRETERM NEONATES: EVIDENCE GENERATION AND IMPLEMENTATION BY COMPARATIVE EFFECTIVENESS RESEARCH (CER) USING REAL WORLD DATA (RWD) FROM A PRACTICE-BASED RESEARCH NETWORK (PBRN)

Summary

Prolonged endotracheal mechanical ventilation (EMV) is associated with ventilator-induced lung injury and bronchopulmonary dysplasia (BPD) in preterm neonates. Many different forms of non-invasive respiratory support (NRS) modes are available and increasingly being used to decrease EMV reliance and duration. Non-invasive positive pressure ventilation (NIPPV) and nasal continuous positive airway pressure (NCPAP) are two commonly utilized prototypical NRS modes.

The objective is to determine the effectiveness of use of NIPPV vs. NCPAP as the primary post- extubation mode of NRS. We hypothesize that use of NCPAP as the primary post-extubation mode of support will yield similar clinical outcomes as compared to NIPPV.

In this “comparative effectiveness” design, centres will self select a strategy of either NIPPV or NCPAP as their primary post-extubation NRS mode. All infants meeting study eligibility criteria will be treated with the adopted post-extubation NRS strategy as part of standard care. '
A centre which selects NIPPV will use this mode as their primary NRS mode of choice whenever positive pressure respiratory support is required post-extubation. Similarly, a centre which selects NCPAP will use that mode as their primary NRS mode on all infants post-extubation whenever positive pressure respiratory support is needed..

The adopted post-extubation strategy must be employed for a minimum of 72 hours post-initial extubation and for any subsequent extubation for a minimum of 24 hours. In addition, the adopted post-extubation NRS strategy will be in effect until 32 weeks PMA, after which time post-extubation support mode – if needed – will be at discretion of the medical team.

Finally, for centres in the NIPPV arm, patients already weaned down to CPAP requiring escalation of respiratory support will be asked to utilize NIPPV prior to intubation if escalation is required.