Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: Study protocol for a randomized controlled trial

Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015

Lung UltraSound Targeted Recruitment (LUSTR): A Novel Protocol to Optimize Open Lung Ventilation in Critically Ill Neonates

This study investigated the effectiveness of an original Lung UltraSound Targeted Recruitment (LUSTR) protocol to improve the success of lung recruitment maneuvers (LRMs), which are performed as a rescue approach in critically ill neonates. All the LUSTR maneuvers, performed on infants with an oxygen saturation/fraction of inspired oxygen (S/F) ratio below 200, were included in this case−control study (LUSTR-group). The LUSTR-group was matched by the initial S/F ratio and underlying respiratory disease with a control group of lung recruitments performed following the standard oxygenation-guided procedure (Ox-group). The primary outcome was the improvement of the S/F ratio (Delta S/F) throughout the LRM. Secondary outcomes included the rate of air leaks. Each group was comprised of fourteen LRMs. As compared to the standard approach, the LUSTR protocol was associated with a higher success of the procedure in terms of Delta S/F (110 ± 47.3 vs. 64.1 ± 54.6, p = 0.02). This result remained significant after adjusting for confounding variables through multiple linear regressions. The incidence of pneumothorax was lower, although not reaching statistical significance, in the LUSTR-group (0 vs. 14.3%, p = 0.15). The LUSTR protocol may be a more effective and safer option than the oxygenation-based procedure to guide open lung ventilation in neonates, potentially improving ventilation and reducing the impact of ventilator-induced lung injury