Elizabeth E Foglia1, Haresh Kirpalani2, Sarah J Ratcliffe3, Peter G Davis4, Marta Thio4, Helmut Hummler5, Gianluca Lista6, Francesco Cavigioli6, Georg M Schmölzer7, Martin Keszler8, Arjan B Te Pas9. 1. Division of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: foglia@chop.edu. 2. Division of Neonatology, Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 3. Division of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA. 4. Newborn Research Center, The Royal Women's Hospital and The University of Melbourne, Victoria, Australia. 5. Department of Pediatrics, Sidra Medicine, Doha, Qatar. 6. Department of Pediatrics, NICU, Ospedale dei Bambini V.Buzzi ASST-FBF-Sacco, Milan, Italy. 7. Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. 8. Department of Pediatrics, Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, Providence, RI. 9. Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
Abstract
OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms. STUDY DESIGN: We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups. RESULTS: Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation. CONCLUSION: Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02139800.
OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms. STUDY DESIGN: We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups. RESULTS: Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation. CONCLUSION: Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02139800.
Authors: Georg M Schmölzer; Jennifer A Dawson; C Omar F Kamlin; Colm P F O'Donnell; Colin J Morley; Peter G Davis Journal: Arch Dis Child Fetal Neonatal Ed Date: 2010-11-16 Impact factor: 5.747
Authors: Jeroen J van Vonderen; C Omar Kamlin; Jennifer A Dawson; Frans J Walther; Peter G Davis; Arjan B te Pas Journal: J Pediatr Date: 2015-05-06 Impact factor: 4.406
Authors: Arjan B te Pas; Melissa Siew; Megan J Wallace; Marcus J Kitchen; Andreas Fouras; Robert A Lewis; Naoto Yagi; Kentaro Uesugi; Susan Donath; Peter G Davis; Colin J Morley; Stuart B Hooper Journal: Pediatr Res Date: 2009-05 Impact factor: 3.756