Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks’ Gestational Age
Authors: Snorri Donaldsson, Thomas Drevhammar, Yinghua Li, Marco Bartocci, Siren Irene Rettedal, Fredrik Lundberg, Per Odelberg-Johnson, Tomasz Szczapa, Thordur Thordarson, Ingrida Pilypiene, Thordur Thorkelsson, Lars Soderstrom, Vladimiras Chijenas, Baldvin Jonsson, Christl Drkosch, Malin Kjellberg, Veronica Frimmel, Louise Tovi, Alexander Rakoff, Noni Wadström, Emma Steen, Sofia Psyllidou, Helena Trottenstam, Leena Taittonen, Leif Evaggelidis, Kajsa Kajser, Oli Olason, Emoke Deschmann, Mireille Vanpee, Sonja Baldursdottir, Giovanna Marchini, Elena Palleri, Anna Gudmundsdottir, Kobrun Gunnarsdottir, Sanne Smit-van der Weiden, Hanne Pike, Marta Szymankiewicz-Breborowicz, Natalia Neumann-Klimasinska, Sonia Kahtan, Zuzanna Owsianska, Hanna Szczapa-Krenz, Svetlana Dauengauer-Kirliene, Violeta Gulbiniene, Virginija Sungailiene, Jolita Kirvaitiene, Kristin Leifsdottir, Hrolfur Brynjarsson, Snjolaug Sveinsdottir
Journal: JAMA Pediatrics (2021)

<h3>Importance</h3> Establishing stable breathing is a key event for preterm infants after birth. Delivery of pressure-stable continuous positive airway pressure and avoiding face mask use could be of importance in the delivery room. <h3>Objective</h3> To determine whether using a new respiratory support system with low imposed work of breathing and short binasal prongs decreases delivery room intubations or death compared with a standard T-piece system with a face mask. <h3>Design, Setting, and Participants</h3> In this unblinded randomized clinical trial, mothers threatening preterm delivery before week 28 of gestation were screened. A total of 365 mothers were enrolled, and 250 infants were randomized before birth and 246 liveborn infants were treated. The trial was conducted in 7 neonatal intensive care units in 5 European countries from March 2016 to May 2020. The follow-up period was 72 hours after intervention. <h3>Interventions</h3> Infants were randomized to either the new respiratory support system with short binasal prongs (n = 124 infants) or the standard T-piece system with face mask (n = 122 infants). The intervention was providing continuous positive airway pressure for 10 to 30 minutes and positive pressure ventilation, if needed, with the randomized system. <h3>Main Outcomes and Measures</h3> The primary outcome was delivery room intubation or death within 30 minutes of birth. Secondary outcomes included respiratory and safety variables. <h3>Results</h3> Of 246 liveborn infants treated, the mean (SD) gestational age was 25.9 (1.3) weeks, and 127 (51.6%) were female. A total of 41 infants (33.1%) receiving the new respiratory support system were intubated or died in the delivery room compared with 55 infants (45.1%) receiving standard care. The adjusted odds ratio was statistically significant after adjusting for stratification variables (adjusted odds ratio, 0.53; 95% CI, 0.30-0.94;<i>P</i> = .03). No significant differences were seen in secondary outcomes or safety variables. <h3>Conclusions and Relevance</h3> In this study, using the new respiratory support system reduced delivery room intubation in extremely preterm infants. Stabilizing preterm infants with a system that has low imposed work of breathing and binasal prongs as interface is safe and feasible. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT02563717