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 trialReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

Trials

, 17:414

First Online: 18 August 2016Received: 07 February 2016Accepted: 31 July 2016DOI: 10.1186-s13063-016-1498-7

Cite this article as: Vento, G., Pastorino, R., Boni, L. et al. Trials 2016 17: 414. doi:10.1186-s13063-016-1498-7

Abstract

BackgroundAlthough 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-designIn this study, 206 spontaneously breathing infants born at 24–27 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.

DiscussionFrom 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 registrationClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015.

KeywordsPreterm infants Lung recruitment HFOV INSURE  Download fulltext PDF



Author: Giovanni Vento - Roberta Pastorino - Luca Boni - Francesco Cota - Virgilio Carnielli - Filip Cools - Carlo Dani - Fabio Mo

Source: https://link.springer.com/







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