Gianluca Lista1, Luca Boni2, Fabio Scopesi3, Fabio Mosca4, Daniele Trevisanuto5, Hubert Messner6, Giovanni Vento7, Rosario Magaldi8, Antonio Del Vecchio9, Massimo Agosti10, Camilla Gizzi11, Fabrizio Sandri12, Paolo Biban13, Massimo Bellettato14, Diego Gazzolo15, Antonio Boldrini16, Carlo Dani17. 1. Division of Neonatology, "V. Buzzi" Children's Hospital, ICP, Milan, Italy; 2. Clinical Trials Coordinating Center, Istituto Toscano Tumori, Florence, Department of Human Pathology and Oncology, University of Florence, Florence, Italy; 3. Neonatal ICU (NICU), Istituto G. Gaslini, Genoa, Italy; 4. Neonatal ICU, Department of Mother and Infant Science, Fondazione IRCCS ''Ca' Granda'' Ospedale Maggiore Policlinico, University of Milan, Milan, Italy; 5. Department of Pediatrics, Padua, Italy; 6. Neonatal ICU of Ospedale Regionale, Bolzano, Italy; 7. Division of Neonatology, Catholic University of Rome, Italy; 8. Division of Neonatology, Neonatal ICU, Ospedali Riuniti, Azienda Ospedaliero-Universitaria, Foggia, Italy; 9. Division of Neonatology, Neonatal ICU, Di Venere Hospital, Bari, Italy; 10. Maternal and Child Health Department, Del Ponte Hospital, A.O. Di Circolo Fondazione Macchi, Varese, Italy; 11. Division of Neonatology, S. Giovanni Calibita Hospital Fatebenefratelli, Isola Tiberina, Rome, Italy; 12. Maternal and Pediatrics Department, Maggiore Hospital, Bologna, Italy; 13. Department of Pediatrics, Pediatric and Neonatal ICU, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; 14. Division of Neonatology, Ospedale San Bortolo, Vicenza, Italy; 15. Department of Maternal Fetal and Neonatal Medicine, C. Arrigo Children's Hospital, Alessandria, Italy; 16. Division of Neonatology and Neonatal ICU, S. Chiara Hospital, University of Pisa, Pisa, Italy; and. 17. Department of Neurosciences, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, Florence, Italy cdani@unifi.it.
Abstract
BACKGROUND: Studies suggest that giving newly born preterm infantssustained lung inflation (SLI) may decrease their need for mechanical ventilation (MV) and improve their respiratory outcomes. METHODS: We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI (25 cm H2O for 15 seconds) followed by nasal continuous positive airway pressure (nCPAP) or nCPAP alone in the delivery room. SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator. The primary end point was the need for MV in the first 72 hours of life. The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia (BPD). RESULTS: A total of 148 infants were enrolled in the SLI group and 143 in the control group. Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group (79 of 148 [53%]) than in the control group (93 of 143 [65%]); unadjusted odds ratio: 0.62 [95% confidence interval: 0.38-0.99]; P = .04). The need for respiratory support and survival without BPD did not differ between the groups. Pneumothorax occurred in 1% (n = 2) of infants in the control group compared with 6% (n = 9) in the SLI group, with an unadjusted odds ratio of 4.57 (95% confidence interval: 0.97-21.50; P = .06). CONCLUSIONS: SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD.
RCT Entities:
BACKGROUND: Studies suggest that giving newly born preterm infantssustained lung inflation (SLI) may decrease their need for mechanical ventilation (MV) and improve their respiratory outcomes. METHODS: We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI (25 cm H2O for 15 seconds) followed by nasal continuous positive airway pressure (nCPAP) or nCPAP alone in the delivery room. SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator. The primary end point was the need for MV in the first 72 hours of life. The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia (BPD). RESULTS: A total of 148 infants were enrolled in the SLI group and 143 in the control group. Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group (79 of 148 [53%]) than in the control group (93 of 143 [65%]); unadjusted odds ratio: 0.62 [95% confidence interval: 0.38-0.99]; P = .04). The need for respiratory support and survival without BPD did not differ between the groups. Pneumothorax occurred in 1% (n = 2) of infants in the control group compared with 6% (n = 9) in the SLI group, with an unadjusted odds ratio of 4.57 (95% confidence interval: 0.97-21.50; P = .06). CONCLUSIONS:SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD.
Authors: Karen E McCall; Andreas D Waldmann; Prue Pereira-Fantini; Regina Oakley; Martijn Miedema; Elizabeth J Perkins; Peter G Davis; Peter A Dargaville; Stephan H Böhm; Raffaele Dellacà; Magdy Sourial; Emanuela Zannin; Anushi E Rajapaksa; Andre Tan; Andy Adler; Inéz Frerichs; David G Tingay Journal: Pediatr Res Date: 2017-07-12 Impact factor: 3.756
Authors: David G Tingay; Anushi Rajapaksa; Karen McCall; Cornelis E E Zonneveld; Don Black; Elizabeth Perkins; Magdy Sourial; Anna Lavizzari; Peter G Davis Journal: Pediatr Res Date: 2016-02-11 Impact factor: 3.756
Authors: Haresh Kirpalani; Sarah J Ratcliffe; Martin Keszler; Peter G Davis; Elizabeth E Foglia; Arjan Te Pas; Melissa Fernando; Aasma Chaudhary; Russell Localio; Anton H van Kaam; Wes Onland; Louise S Owen; Georg M Schmölzer; Anup Katheria; Helmut Hummler; Gianluca Lista; Soraya Abbasi; Daniel Klotz; Burkhard Simma; Vinay Nadkarni; Francis R Poulain; Steven M Donn; Han-Suk Kim; Won Soon Park; Claudia Cadet; Juin Yee Kong; Alexandra Smith; Ursula Guillen; Helen G Liley; Andrew O Hopper; Masanori Tamura Journal: JAMA Date: 2019-03-26 Impact factor: 56.272