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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.

ABSTRACT: 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.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.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.ClinicalTrials.gov identifier: NCT02482766 . Registered on 1 June 2015.

SUBMITTER: Vento G

PROVIDER: S-EPMC4991115 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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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.

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

Trials 20160818

<h4>Background</h4>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 impo ...[more]

PMID: 27538798

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Project description:Surfactant replacement therapy (SRT) has been shown to reduce mortality and air leaks in preterm neonates from high-income countries (HICs). The safety and efficacy of SRT in low- and middle- income countries (LMICs) have not been systematically evaluated. The major objectives of this review were to assess the (1) efficacy and safety, and (2) feasibility and cost effectiveness of SRT in LMIC settings. We searched the following databases-MEDLINE, CENTRAL, CINAHL, EMBASE and WHOLIS using the search terms 'surfactant' OR 'pulmonary surfactant'. Both experimental and observational studies that enrolled preterm neonates with or at-risk of respiratory distress syndrome (RDS) and required surfactant (animal-derived or synthetic) were included. A total of 38 relevant studies were found; almost all were from level-3 neonatal units. Pooled analysis of two randomized controlled trials (RCTs) and 22 observational studies showed a significant reduction in mortality at the last available time point in neonates who received SRT (relative risk (RR) 0.67; 95% confidence interval (CI) 0.57 to 0.79). There was also a significant reduction in the risk of air leaks (five studies; RR 0.51; 0.29 to 0.90). One RCT and twelve observational studies reported the risk of bronchopulmonary dysplasia (BPD) with contrasting results; while the RCT and most before-after/cohort studies showed a significant reduction or no effect, the majority of the case-control studies demonstrated significantly higher odds of receiving SRT in neonates who developed BPD. Two studies-one RCT and one observational-found no difference in the proportion of neonates developing pulmonary hemorrhage, while another observational study reported a higher incidence in those receiving SRT. The failure rate of the intubate-surfactant-extubate (InSurE) technique requiring mechanical ventilation or referral varied from 34 to 45% in four case-series. No study reported on the cost effectiveness of SRT. Available evidence suggests that SRT is effective, safe and feasible in level-3 neonatal units and has the potential to reduce neonatal mortality and air leaks in low-resource settings as well. However, there is a need to generate more evidence on the cost effectiveness of SRT and its effect on BPD in LMIC settings.

Dataset Information

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.

Publications

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.

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