BACKGROUND: We have developed a rapid method, based on lamellar body counts (LBC) on gastric aspirate, for identifying newborns who will develop respiratory distress syndrome with a need for surfactant supplementation. OBJECTIVE: We set out to test whether it was possible to improve the outcome when used in a clinical trial. METHODS: We randomly assigned 380 infants born at 24-29 weeks' gestation and supported withnasal continuous positive airway pressure (nCPAP) to receive surfactant guided either by LBC (intervention group) or increasing need for oxygen (control group). The primary outcome was mechanical ventilation or death within 5 days. Secondary outcomes included need for oxygen expressed by arterial to alveolar oxygen tension ratio (a/APO2) at the age of 6 h and need for oxygen at day 28. RESULTS: The primary outcomes were equal (25%) in the two groups. The intervention group had higher a/APO2 than the control group at 6 h, median 0.64 versus 0.52 (p < 0.01), and the subgroup with gestational age 26-29 weeks needed fewer days of oxygen supplementation than the controls, median 2 vs. 9 days (p = 0.01), and fewer infants needed oxygen at day 28 (p = 0.04). Furthermore, there was a tendency in the intervention group towards a shorter duration of nCPAP. Too little or viscose aspirate in 23% of the cases was a limitation of the method. CONCLUSION: Using LBC test as indicator of lung maturity and early surfactant therapy in very preterm newborns, it is possible to reduce the need for oxygen supplementation.
RCT Entities:
BACKGROUND: We have developed a rapid method, based on lamellar body counts (LBC) on gastric aspirate, for identifying newborns who will develop respiratory distress syndrome with a need for surfactant supplementation. OBJECTIVE: We set out to test whether it was possible to improve the outcome when used in a clinical trial. METHODS: We randomly assigned 380 infants born at 24-29 weeks' gestation and supported with nasal continuous positive airway pressure (nCPAP) to receive surfactant guided either by LBC (intervention group) or increasing need for oxygen (control group). The primary outcome was mechanical ventilation or death within 5 days. Secondary outcomes included need for oxygen expressed by arterial to alveolar oxygen tension ratio (a/APO2) at the age of 6 h and need for oxygen at day 28. RESULTS: The primary outcomes were equal (25%) in the two groups. The intervention group had higher a/APO2 than the control group at 6 h, median 0.64 versus 0.52 (p < 0.01), and the subgroup with gestational age 26-29 weeks needed fewer days of oxygen supplementation than the controls, median 2 vs. 9 days (p = 0.01), and fewer infants needed oxygen at day 28 (p = 0.04). Furthermore, there was a tendency in the intervention group towards a shorter duration of nCPAP. Too little or viscose aspirate in 23% of the cases was a limitation of the method. CONCLUSION: Using LBC test as indicator of lung maturity and early surfactant therapy in very preterm newborns, it is possible to reduce the need for oxygen supplementation.
Authors: Henrik Verder; Christian Heiring; Howard Clark; David Sweet; Torben E Jessen; Finn Ebbesen; Lars J Björklund; Bengt Andreasson; Lars Bender; Aksel Bertelsen; Marianne Dahl; Christian Eschen; Jesper Fenger-Grøn; Stine F Hoffmann; Agnar Höskuldsson; Maria Bruusgaard-Mouritsen; Fredrik Lundberg; Anthony D Postle; Peter Schousboe; Peter Schmidt; Hristo Stanchev; Lars Sørensen Journal: Acta Paediatr Date: 2016-12-20 Impact factor: 2.299
Authors: Anna Lavizzari; Chiara Veneroni; Francesco Beretta; Valeria Ottaviani; Claudia Fumagalli; Marta Tossici; Mariarosa Colnaghi; Fabio Mosca; Raffaele L Dellacà Journal: Respir Res Date: 2021-12-20