Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial

Elizabeth E Foglia, Louise S Owen, Marta Thio, Sarah J Ratcliffe, Gianluca Lista, Arjan Te Pas, Helmut Hummler, Vinay Nadkarni, Anne Ades, Michael Posencheg, Martin Keszler, Peter Davis, Haresh Kirpalani, Elizabeth E Foglia, Louise S Owen, Marta Thio, Sarah J Ratcliffe, Gianluca Lista, Arjan Te Pas, Helmut Hummler, Vinay Nadkarni, Anne Ades, Michael Posencheg, Martin Keszler, Peter Davis, Haresh Kirpalani

Abstract

Background: Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question.

Methods/design: This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age.

Trial registration: www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Figures

Figure 1
Figure 1
Resuscitation algorithm. abbreviations in figure: CPAP, continuous positive airway pressure; FiO2,fraction of inspired oxygen; HR, heart rate; NRP, neonatal resuscitation program; PPV, positive pressure ventilation; SI, sustained inflation; SpO2, oxygen saturation.

References

    1. Vyas H, Field D, Milner AD, Hopkin IE. Determinants of the first inspiratory volume and functional residual capacity at birth. Pediatr Pulmonol. 1986;2:189–193. doi: 10.1002/ppul.1950020403.
    1. Heldt GP, McIlroy MB. Distortion of chest wall and work of diaphragm in preterm infants. J Appl Physiol. 1987;62:164–169.
    1. Heldt GP, McIlroy MB. Dynamics of chest wall in preterm infants. J Appl Physiol. 1987;62:170–174.
    1. Deoras KS, Greenspan JS, Wolfson MR, Keklikian EN, Shaffer TH, Allen JL. Effects of inspiratory resistive loading on chest wall motion and ventilation: Differences between preterm and full-term infants. Pediatr Res. 1992;32:589–594. doi: 10.1203/00006450-199211000-00022.
    1. Obladen M. Factors influencing surfactant composition in the newborn infant. Eur J Pediatr. 1978;128:129–143. doi: 10.1007/BF00444298.
    1. Committee on fetus and newborn Respiratory support in preterm infants at birth. Pediatrics. 2014;133:171–174. doi: 10.1542/peds.2013-3442.
    1. Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, et al. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010;362:1970–1979. doi: 10.1056/NEJMoa0911783.
    1. Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet J-M, Carlin JB. COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008;358:700–708. doi: 10.1056/NEJMoa072788.
    1. Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, et al. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011;128:e1069–e1076. doi: 10.1542/peds.2010-3848.
    1. Vyas H, Milner AD, Hopkin IE, Boon AW. Physiologic responses to prolonged and slow-rise inflation in the resuscitation of the asphyxiated newborn infant. J Pediatr. 1981;99:635–639. doi: 10.1016/S0022-3476(81)80279-X.
    1. Polglase GR, Miller SL, Barton SK, Baburamani AA, Wong FY, Aridas JDS, et al. Initiation of resuscitation with high tidal volumes causes cerebral hemodynamic disturbance, brain inflammation and injury in preterm lambs. PLoS One. 2012;7:e39535. doi: 10.1371/journal.pone.0039535.
    1. Polglase GR, Tingay DG, Bhatia R, Berry CA, Kopotic RJ, Kopotic CP, et al. Pressure- versus volume-limited sustained inflations at resuscitation of premature newborn lambs. BMC Pediatr. 2014;14:43. doi: 10.1186/1471-2431-14-43.
    1. Sobotka KS, Hooper SB, Allison BJ, Te Pas AB, Davis PG, Morley CJ, et al. An initial sustained inflation improves the respiratory and cardiovascular transition at birth in preterm lambs. Pediatr Res. 2011;70:56–60. doi: 10.1203/PDR.0b013e31821d06a1.
    1. Klingenberg C, Sobotka KS, Ong T, Allison BJ, Schmölzer GM, Moss TJM, et al. Effect of sustained inflation duration; resuscitation of near-term asphyxiated lambs. Arch Dis Child Fetal Neonatal Ed. 2013;98:F222–F227. doi: 10.1136/archdischild-2012-301787.
    1. te Pas AB, Siew M, Wallace MJ, Kitchen MJ, Fouras A, Lewis RA, et al. Establishing functional residual capacity at birth: The effect of sustained inflation and positive end-expiratory pressure in a preterm rabbit model. Pediatr Res. 2009;65:537–541. doi: 10.1203/PDR.0b013e31819da21b.
    1. te Pas AB, Siew M, Wallace MJ, Kitchen MJ, Fouras A, Lewis RA, et al. Effect of sustained inflation length on establishing functional residual capacity at birth in ventilated premature rabbits. Pediatr Res. 2009;66:295–300. doi: 10.1203/PDR.0b013e3181b1bca4.
    1. Lindner W, Högel J, Pohlandt F. Sustained pressure - controlled inflation or intermittent mandatory ventilation in preterm infants in the delivery room? A randomized, controlled trial on initial respiratory support via nasopharyngeal tube. Acta Paediatr. 2005;94:303–309.
    1. te Pas AB, Walther FJ. A randomized, controlled trial of delivery-room respiratory management in very preterm infants. Pediatrics. 2007;120:322–329. doi: 10.1542/peds.2007-0114.
    1. Lista G, Fontana P, Castoldi F, Cavigioli F, Dani C. Does sustained lung inflation at birth improve outcome of preterm infants at risk for respiratory distress syndrome? Neonatology. 2011;99:45–50. doi: 10.1159/000298312.
    1. Lista G, Boni L, Scopesi F, Mosca F, Trevisanuto D, Messner H, et al. Sustained lung inflation at birth for preterm infants: a randomized clinical trial. Pediatrics. 2015;135(2):e457–e464. doi: 10.1542/peds.2014-1692.
    1. Walsh MC, Wilson-Costello D, Zadell A, Newman N, Fanaroff A. Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia. J Perinatol. 2003;23:451–456. doi: 10.1038/sj.jp.7210963.
    1. American Academy of Pediatrics and the American Heart Association . Neonatal Resuscitation Textbook. 6. USA: American Academy of Pediatrics; 2011.
    1. Hibbs AM, Black D, Palermo L, Cnaan A, Luan X, Truog WE, et al. Accounting for multiple births in neonatal and perinatal trials: Systematic review and case study. J Pediatr. 2010;156:202–208. doi: 10.1016/j.jpeds.2009.08.049.
    1. Donner A, Birkett N, Buck C. Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol. 1981;114:906–914.
    1. Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing professional practice in europe group (EU BIOMED II concerted action) J Health Serv Res Policy. 2000;5:12–16.
    1. DAMOCLES Study Group NHS health technology assessment programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job wel. Lancet. 2005;365:711–722. doi: 10.1016/S0140-6736(05)17965-3.
    1. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549–556. doi: 10.2307/2530245.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (redcap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Kamlin COF, O’Donnell CPF, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006;71:319–321. doi: 10.1016/j.resuscitation.2006.04.015.
    1. Kamlin COF, Dawson JA, O’Donnell CPF, Morley CJ, Donath SM, Sekhon J, et al. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008;152:756–760. doi: 10.1016/j.jpeds.2008.01.002.
    1. Schilleman K, Siew ML, Lopriore E, Morley CJ, Walther FJ, Te Pas AB. Auditing resuscitation of preterm infants at birth by recording video and physiological parameters. Resuscitation. 2012;83:1135–1139. doi: 10.1016/j.resuscitation.2012.01.036.
    1. Poulton DA, Schmölzer GM, Morley CJ, Davis PG. Assessment of chest rise during mask ventilation of preterm infants in the delivery room. Resuscitation. 2011;82:175–179. doi: 10.1016/j.resuscitation.2010.10.012.
    1. American Lung Association. Bronchopulmonary dysplasia. Accessed 1 July 2014.
    1. Richardson DK, Corcoran JD, Escobar GJ, Lee SK. SNAP-II and SNAPPE-II: Simplified newborn illness severity and mortality risk scores. J Pediatr. 2001;138:92–100. doi: 10.1067/mpd.2001.109608.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться