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

Survey of neonatal respiratory care and surfactant administration in very preterm infants in the Italian Neonatal Network

Variation of respiratory care is described between centers around the world. The Italian Neonatal Network (INN), as a national group of the Vermont-Oxford Network (VON) allows to perform a wide analysis of respiratory care in very low birth weight infants

Changes in ventilator strategies and outcomes in preterm infants

Background: Although life-saving, intubation and mechanical ventilation can lead to complications including bronchopulmonary dysplasia (BPD). In order to reduce the incidence of BPD, non-invasive ventilation (NIV) is increasingly used. Objective: The aim of our study was to describe changes in ventilator strategies and outcomes between 2006 and 2010 in the Italian Neonatal Network (INN). Design: Multicentre cohort study. Settings: 31 tertiary level neonatal units participating in INN in 2006 and 2010. Patients: 2465 preterm infants 23-30 weeks gestational age (GA) without congenital anomalies. Main outcomes measures: Death, BPD and other variables defined according to Vermont Oxford Network. Logistic regressions, adjusting for confounders and clustering for hospitals, were used. Results: Similar numbers of infants were studied between 2006 and 2010 (1234 in 2006 and 1231 in 2010). The baseline risk of populations studied (GA, birth weight and Vermont Oxford Network Risk-Adjustment score) did not change. After adjusting for confounding variables, infants receiving invasive mechanical ventilation decreased (OR=0.72, 95% CI 0.58 to 0.89) while NIV increased (OR=1.75, 95% CI 1.39 to 2.21); intubation in delivery room decreased (OR=0.64, 95% CI 0.51 to 0.79). Considering outcomes, there was a significant reduction in mortality (OR=0.73, 95% CI 0.55 to 0.96) and in the combined outcome mortality or BPD (OR=0.76, 95% CI 0.62 to 0.94). Conclusions: Despite a stable baseline risk, from 2006 to 2010, we observed a lower level of invasiveness, a reduction of mechanical ventilation and an increase of NIV use, and this was accompanied by a decrease in risk-adjusted mortality and BPD

Antifungal prophylaxis: identification of preterm neonates at high risk for invasive fungal infection.

We read with great interest the article by Healy et al,1 who evaluated the impact of fluconazole prophylaxis (FP) for extremely low birth weight infants on invasive candidiasis (IC) incidence, IC-related mortality rates, and fluconazole susceptibility of Candida isolated. We wish to make some comments thereon. Healy et al1 demonstrated a decrease of IC in NICU infants, after the introduction of FP, from 0.6% to 0.3%, and a 3.6 fold decrease in ELBW infants. Recent studies have demonstrated that prophylactic use of fluconazole is effective in reducing the incidence of fungal colonization and fungal systemic infections in preterm neonates.2,3 However, because of the lack of larger multicenter randomized trials and data on long term neurodevelopment outcomes as well as concern about unwanted side effects and development of Candida resistance, FP in high risk infants remains controversial. For these reasons, selecting only those infants at highest risk for IC may delay or prevent the emergence of resistance. In recent studies, the criteria chosen to identify \u201cthe high-risk neonate\u201d were <1500 g birth weight (BW) and the presence of a central vascular catheter or endotracheal tube.4 These criteria seem to be too wide, because they could regard almost all the population sheltered in a NICU. In our NICU, FP as well as antibiotic prophylaxis did not exist, and Candida-related mortality was nearly 20% in extremely low birth weight infants. To prevent IC, we introduced a protocol of Candida surveillance cultures from stool and bronchoalveolar lavage fluid in intubated infants, and every infant who developed IC was identified and IC-related mortality was eliminated.5 All neonates with IC had a BW of 27 weeks

Pulmonary infections in preterm newborns

no abstract availabl

The role of Candida surveillance cultures for identification of a preterm subpopulation at hightest risk for invasive fungal infection

The role of Candida surveillance cultures for identification of a preterm subpopulation at hightest risk for invasive fungal infectio