Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial

Francesco Cresi, Federica Chiale, Elena Maggiora, Silvia Maria Borgione, Mattia Ferroglio, Federica Runfola, Giulia Maiocco, Chiara Peila, Enrico Bertino, Alessandra Coscia, Francesco Cresi, Federica Chiale, Elena Maggiora, Silvia Maria Borgione, Mattia Ferroglio, Federica Runfola, Giulia Maiocco, Chiara Peila, Enrico Bertino, Alessandra Coscia

Abstract

Background: Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established. Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant's breathing efforts. The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support.

Methods: An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort. During the whole duration of the study, the patient's cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer. The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO2 necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients.

Discussion: It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant's breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation.

Trial registration: ClinicalTrials.gov NCT03289936 . Registered on September 21, 2017.

Keywords: Cardiorespiratory events; NIPPV; Non-invasive ventilation; Preterm infants; RDS; SNIPPV; Synchronization.

Conflict of interest statement

Engineer Mattia Ferroglio declares to have a contract with GINEVRI srl as responsible for technical assistance for the Piedmont region. All the other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Spirit figure

References

    1. Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432–50.
    1. Cummings JJ, Polin RA, Committee on Fetus and Newborn, American Academy of Pediatrics. Noninvasive Respiratory Support. Pediatrics. 2016;137(1). 10.1542/peds.2015-3758.
    1. Isayama T, Iwami H, McDonald S, Beyene J. Association of noninvasive ventilation strategies with mortality and bronchopulmonary dysplasia among preterm infants: a systematic review and meta-analysis. JAMA. 2016;316(6):611–624. doi: 10.1001/jama.2016.10708.
    1. Owen LS, Manley BJ. Nasal intermittent positive pressure ventilation in preterm infants: equipment, evidence, and synchronization. Semin Fetal Neonatal Med. 2016;21(3):146–153. doi: 10.1016/j.siny.2016.01.003.
    1. Permall DL, Pasha AB, Chen X. Current insights in non-invasive ventilation for the treatment of neonatal respiratory disease. Ital J Pediatr. 2019;45(1):105. doi: 10.1186/s13052-019-0707-x.
    1. Ferguson KN, Roberts CT, Manley BJ, Davis PG. Interventions to improve rates of successful extubation in preterm infants: a systematic review and meta-analysis. JAMA Pediatr. 2017;171(2):165. doi: 10.1001/jamapediatrics.2016.3015.
    1. Lemyre B, Davis PG, De Paoli AG, Kirpalani H. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. 2017.
    1. Moretti C, Gizzi C, Montecchia F, Barbàra CS, Midulla F, Sanchez-Luna M, et al. Synchronized nasal intermittent positive pressure ventilation of the newborn: technical issues and clinical results. Neonatology. 2016;109(4):359–365. doi: 10.1159/000444898.
    1. Mowitz ME, Zupancic JAF, Millar D, Kirpalani H, Gaulton JS, Roberts RS, et al. Prospective economic evaluation alongside the non-invasive ventilation trial. J Perinatol Off J Calif Perinat Assoc. 2017;37(1):61–6.
    1. Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016;12:CD005384.
    1. Charles E, Hunt KA, Rafferty GF, Peacock JL, Greenough A. Work of breathing during HHHFNC and synchronised NIPPV following extubation. Eur J Pediatr. 2019;178(1):105–110. doi: 10.1007/s00431-018-3254-3.
    1. Gizzi C, Montecchia F, Panetta V, Castellano C, Mariani C, Campelli M, Papoff P, Moretti C, Agostino R. Is synchronised NIPPV more effective than NIPPV and NCPAP in treating apnoea of prematurity (AOP)? A randomised cross-over trial. Arch Dis Child - Fetal Neonatal Ed. 2015;100(1):F17–F23. doi: 10.1136/archdischild-2013-305892.
    1. Salvo V, Lista G, Lupo E, Ricotti A, Zimmermann LJI, Gavilanes AWD, Barberi I, Colivicchi M, Temporini F, Gazzolo D. Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT. Pediatrics. 2015;135(3):444–451. doi: 10.1542/peds.2014-0895.
    1. Manley BJ, Doyle LW, Owen LS, Davis PG. Extubating Extremely Preterm Infants: Predictors of Success and Outcomes following Failure. J Pediatr. 2016;173:45–49. doi: 10.1016/j.jpeds.2016.02.016.
    1. Alexiou S, Panitch HB. Physiology of non-invasive respiratory support. Semin Fetal Neonatal Med. 2016;21(3):174–180. doi: 10.1016/j.siny.2016.02.007.
    1. Moretti C, Giannini L, Fassi C, Gizzi C, Papoff P, Colarizi P. Nasal flow-synchronized intermittent positive pressure ventilation to facilitate weaning in very low-birthweight infants: Unmasked randomized controlled trial. Pediatr Int. 2008;50(1):85–91. doi: 10.1111/j.1442-200X.2007.02525.x.
    1. Li W, Long C, Zhangxue H, Jinning Z, Shifang T, Juan M, Renjun L, Yuan S. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure for preterm infants with respiratory distress syndrome: a meta-analysis and up-date. Pediatr Pulmonol. 2015;50(4):402–409. doi: 10.1002/ppul.23130.
    1. Handoka NM, Azzam M, Gobarah A. Predictors of early synchronized non-invasive ventilation failure for infants < 32 weeks of gestational age with respiratory distress syndrome. Arch Med Sci AMS. 2019;15(3):680–687. doi: 10.5114/aoms.2019.83040.
    1. Aghai ZH, Saslow JG, Nakhla T, Milcarek B, Hart J, Lawrysh‐Plunkett R, et al. Synchronized nasal intermittent positive pressure ventilation (SNIPPV) decreases work of breathing (WOB) in premature infants with respiratory distress syndrome (RDS) compared to nasal continuous positive airway pressure (NCPAP). Pediatr Pulmonol. 2006;41(9):875–81.
    1. Huang L, Mendler MR, Waitz M, Schmid M, Hassan MA, Hummler HD. Effects of synchronization during noninvasive intermittent mandatory ventilation in preterm infants with respiratory distress syndrome immediately after extubation. Neonatology. 2015;108(2):108–114. doi: 10.1159/000431074.
    1. Bhandari V. Noninvasive respiratory support in the preterm infant. Clin Perinatol. 2012;39(3):497–511. doi: 10.1016/j.clp.2012.06.008.
    1. Gizzi C, Papoff P, Giordano I, Massenzi L, Barbàra CS, Campelli M, Panetta V, Agostino R, Moretti C. Flow-synchronized nasal intermittent positive pressure ventilation for infants <32 weeks’ gestation with respiratory distress syndrome. Crit Care Res Pract. 2012;2012:1–7. doi: 10.1155/2012/301818.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner