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

Vento, Giovanni; Pastorino, Roberta; Boni, Luca; Cota, Francesco; Carnielli, Virgilio P.; Cools, Filip; Dani, Carlo; Mosca, Fabio; Pillow, J. Jane; Polglase, Graeme R.; Tagliabue, Paolo; Kaam, Anton H. van; Ventura, Maria Luisa; Tana, Milena; Tirone, Chiara; Aurilia, Claudia; Lio, Alessandra; Ricci, Cinzia; Gambacorta, Alessandro; Consigli, Chiara; D'Onofrio, D; Gizzi, Camilla; Massenzi, Luca; Cardilli, Viviana; Casati, Alessandra; Bottino, Roberto; Pontiggia, F; Ciarmoli, Elena; Martinelli, Stefano; Ilardi, Laura; Colnaghi, Mariarosa; Matassa, Piero Giuseppe; Vendettuoli, Valentina; Villani, Paolo; Fusco, Francesca Paola; Gazzolo, Diego; Ricotti, Alberto; Ferrero, Federica; Stasi, Ilaria; Magaldi, Rosario; Maffei, G; Presta, G.; Perniola, Roberto; Messina, Francesco; Montesano, Giovanna; Poggi, Chiara; Giordano, Lucio; Roma, Enza; Grassia, Carolina; Ausanio, Gaetano; Sandri, Fabrizio; Mescoli, Giovanna; Giura, Francesco; Garani, Giampaolo; Solinas, Agostina; Lucente, Maria Stella; Nigro, Gabriella; Vecchio, Antonello Del; Petrillo, Flavia; Orfeo, Luigi; Grappone, Lidia; Quartulli, Lorenzo; Scorrano, Antonio; Messner, Hubert; Staffler, Alex; Gargano, Giancarlo; Balestri, Eleonora; Nobile, Stefano; Cacace, Caterina; Meli, Valerio; Dallaglio, Sara; Betta, Pasqua; Mattia, Loretta; Gitto, Eloisa; Vitaliti, Marcello; Re, Maria Paola; Vedovato, Stefania; Grison, Alessandra; Berardi, Alberto; Torcetta, Francesco; Guidotti, Isotta; Fabio, Sandra Di; Maranella, Eugenia; Mondello, Isabella; Visentin, Stefano; Tormena, F.

doi:10.1186/s13063-016-1498-7

Cited by 15 publications

(18 citation statements)

References 34 publications

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“…The intervention will be regarded as being successful if it lowers the rate of the primary endpoints to 30%. This follows the expectations within similar studies [15]. To lower the rate of primary endpoints from 50 to 30% and to confirm this via Cochran-Mantel-Haenszel test (level of significance = 0.05, power = 80%), a sample size of 103 patients per group will be needed.…”

Section: Sample Size {14}supporting

confidence: 73%

Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

Waitz

Engel

Schloesser

et al. 2020

Trials

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Background Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP) and has been shown to reduce the need for intubation and invasive mechanical ventilation in very low birth weight infants with respiratory distress syndrome. However, CPAP failure rates of 50% are reported in large randomized controlled trials. A possible explanation for these failure rates is the application of insufficient low levels of PEEP during nasal CPAP treatment to maintain adequate functional residual capacity shortly after birth. The optimum PEEP level to treat symptoms of respiratory distress in very low birth weight infants has not been assessed in clinical studies. The aim of the study is to compare two different PEEP levels during nasal CPAP treatment in preterm infants. Methods In this randomized multicenter trial, 216 preterm infants born at 26 + 0–29 + 6 gestational weeks will be allocated to receive a higher (6–8 cmH2O) or a lower (3–5 cmH2O) PEEP during neonatal resuscitation and the first 120 h of life. The PEEP level within each group will be titrated throughout the intervention based on the FiO2 (fraction of inspired oxygen concentration) requirements to keep oxygenation within the target range. The primary outcome is defined as the need for intubation and mechanical ventilation for > 1 h or being not ventilated but reaching one of the two pre-defined CPAP failure criteria (FiO2 > 0.5 for > 1 h or pCO2 ≥ 70 mmHg in two consecutive blood gas analyses at least 2 h apart). Discussion Based on available data from the literature, the optimum level of PEEP that most effectively treats respiratory distress syndrome in preterm infants is unknown, since the majority of large clinical trials applied a wide range of PEEP levels (4–8 cmH2O). The rationale for our study hypothesis is that the early application of a higher PEEP level will more effectively counteract the collapsing properties of the immature and surfactant-deficient lungs and that the level of inspired oxygen may serve as a surrogate marker to guide PEEP titration. Finding the optimum noninvasive continuous distending pressure during early nasal CPAP is required to improve CPAP efficacy and as a consequence to reduce the exposure to ventilator-induced lung injury and the incidence of chronic lung disease in this vulnerable population of very preterm infants. Trial registration drks.de DRKS00019940. Registered on March 13, 2020

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Section: Sample Size {14}supporting

confidence: 73%

Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

Waitz

Engel

Schloesser

et al. 2020

Trials

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“…However, the INSURE (intubation-surfactant-extubation) technique of surfactant administration is an invasive operation, and it is not successful in all preterm neonates with RDS, with a reported failure rate ranging from 19 to 69%. And the unsuccessful INSURE technique required subsequent intratracheal ventilation [18]. In our review with meta-analysis from two trials of Li et al [10] and Colnaghi et al [12], a remarkable decrease was demonstrated for the need of surfactant in the group of infants who received Heliox, and the difference was statistically significant.…”

Section: Discussionmentioning

confidence: 84%

Noninvasive Ventilation with Heliox for Respiratory Distress Syndrome in Preterm Infant: A Systematic Review and Meta-Analysis

Chen

et al. 2016

Canadian Respiratory Journal

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Objectives. To assess whether noninvasive ventilation with Heliox reduces the need for endotracheal ventilation and subsequent complications in preterm infants with respiratory distress syndrome (RDS). Methods. A search of major electronic databases, including MEDLINE and the Cochrane Central Register of Controlled Trials, for randomized or quasi-randomized controlled trials that compared noninvasive ventilation with Heliox versus noninvasive ventilation with standard gas for preterm infants with RDS was performed. The primary outcome was the incidence of intubation. The secondary outcomes were the level of PaCO2, the use of surfactant, and other complications. Results. Two randomized and one quasi-randomized controlled trials including 123 preterm infants were assessed. Heliox was found to significantly decrease the incidence of intubation (RR: 0.42; 95% CI: 0.23 to 0.78), the level of PaCO2 (MD: −9.61; 95% CI: −15.76 to −03.45), and the use of surfactant (RR: 0.25; 95% CI: 0.10 to 0.61) as compared with standard gas. No significant differences were found in other secondary outcomes. Conclusions. Noninvasive ventilation with Heliox decreases the incidence of intubation in preterm infants suffering from RDS. However, data on clinical outcomes are limited. Larger trials are needed to verify the beneficial effects.

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“…In this retrospective study of very low birth weight infants, they showed that positive pressure ventilation (PPV) use in DR using RAM NC resulted in less need for intubation, chest compressions, and epinephrine administration when compared with a face mask for PPV in the DR. 8 Other pulmonary recruitment strategies in the DR, such as the use of sustained inflation (SI) and caffeine in the DR, are currently being evaluated. 9,10 Since November 2016, as part of an ongoing trial named IN-REC-SUR-E (INtubate-RECruit-SURfactant-Extubate), 11 our group has standardized the approach to extremely low GA neonates (ELGANs) in the DR with the use of a protocol that includes SI 9 followed by a nasal continuous positive airway pressure (NCPAP) (range: 6-8 cm of H 2 O) delivered through RAM NC. Prior to this time period, these infants were resuscitated with SI using face mask followed by the application of CPAP of 5 cm H 2 O with a nasopharyngeal tube.…”

mentioning

confidence: 99%

Pulmonary Recruitment Strategy in Preterm Neonates < 29 Weeks of Gestational Age to Reduce the Need for Intubation in the Delivery Room

Petrillo¹,

Valenzano²,

Franco³

et al. 2019

Amer J Perinatol

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Background The application of noninvasive ventilation (NIV) modalities from birth in the delivery room (DR) during fetal–neonatal transition reduces the need for invasive mechanical ventilation, mortality, and bronchopulmonary dysplasia (BPD). The use of a RAM nasal cannula (RAM NC) in the DR for resuscitation results in less need for intubation, chest compressions, and epinephrine administration when compared with using a face mask for PPV in the DR. Objective To evaluate the need for endotracheal intubation in the DR among extremely low gestational age neonates treated at birth with sustained inflation (SI) followed by a nasal continuous positive airway pressure (NCPAP) (range: 6–8 cm of H2O) delivered through the RAM NC. Study Design A retrospective study was conducted to compare the use of NIV techniques in the DR and the need for intubation in the DR in premature infants 23 to 28 weeks' gestational age from December 2016 to July 2018 (group A). These data were compared with those of premature inborn infants with similar GA born between April 2015 and November 2016 (group B). In the DR, immediately after birth, neonates in group A received SI through RAM NC followed by CPAP ranging from 6 to 8 cm H2O, whereas the neonates in group B were treated in the DR with SI administered through a face mask followed by the application of CPAP of 5 cm H2O delivered through a nasopharyngeal tube. Results A total of 65 preterm infants 23 to 28 weeks of gestational age, 31 in group A and 34 in group B, were included in the study. The percentage of neonates intubated in the DR was significantly lower in group A (p < 0.008). In both groups, no neonates died in the DR, and no one required epinephrine and/or chest compressions. For those neonates who did not require intubation in the DR, there was no significant difference in the average FiO2 on arrival in the neonatal intensive care unit, rate of intubation within 24 hours, and use of surfactant. The incidence of BPD was similar in the two groups. Only one infant in group A developed moderate BPD, and no one needed oxygen and/or ventilatory assistance at discharge. Mortality was similar in the two groups, with a slight prevalence in group B (27.7 vs. 19.2%). Conclusion SI with RAM NC followed by NCPAP ranging from 6 to 8 cm H2O, administered with RAM NC resulted in a significant reduction of intubation in the DR.

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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

Cited by 15 publications

References 34 publications

Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

Noninvasive Ventilation with Heliox for Respiratory Distress Syndrome in Preterm Infant: A Systematic Review and Meta-Analysis

Pulmonary Recruitment Strategy in Preterm Neonates < 29 Weeks of Gestational Age to Reduce the Need for Intubation in the Delivery Room

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