Browsing by Author "Kanmaz Kutman, H. Gozde"

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    Two-year outcomes after minimally invasive surfactant therapy in preterm infants follow-up of the OPTIMIST-a randomized clinical trial
    (Amer Medical Assoc, 2023-09-11) Dargaville, Peter A.; Kamlin, C. Omar F.; Orsini, Francesca; Wang, Xiaofang; De Paoli, Antonio G.; Kanmaz Kutman, H. Gozde; Cetinkaya, Merih; Kornhauser-Cerar, Lilijana; Derrick, Matthew; Ozkan, Hilal; Hulzebos, Christian V.; Schmoelzer, Georg M.; Aiyappan, Ajit; Lemyre, Brigitte; Kuo, Sheree; Rajadurai, Victor S.; O'Shea, Joyce; Biniwale, Manoj; Ramanathan, Rangasamy; Kushnir, Alla; Bader, David; Thomas, Mark R.; Chakraborty, Mallinath; Buksh, Mariam J.; Bhatia, Risha; Sullivan, Carol L.; Shinwell, Eric S.; Dyson, Amanda; Barker, David P.; Kugelman, Amir; Donovan, Tim J.; Goss, Kevin C. W.; Tauscher, Markus K.; Murthy, Vadivelam; Ali, Sanoj K. M.; Clark, Howard W.; Soll, Roger F.; Johnson, Samantha; Cheong, Jeanie L. Y.; Carlin, John B.; Davis, Peter G.; OPTIMIST-A Trial Investigators; ÖZKAN, HİLAL; Bursa Uludağ Üniversitesi/Tıp Fakültesi/Çocuk Sağlığı ve Hastalıkları Anabilim Dalı/Neonatoloji Bilim Dalı.; JHM-8406-2023
    IMPORTANCE The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified.OBJECTIVE To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years' corrected age.DESIGN, SETTING, AND PARTICIPANTS Follow-up study of a randomized clinical trial with blinding of clinicians and outcome assessors conducted in 33 tertiary-level neonatal intensive care units in 11 countries. The trial included 486 infants with a gestational age of 25 to 28 weeks supported with continuous positive airway pressure (CPAP). Collection of follow-up data at 2 years' corrected age was completed on December 9, 2022.INTERVENTIONS Infants assigned to MIST (n = 242) received exogenous surfactant (200 mg/kg poractant alfa) via a thin catheter; those assigned to the control group (n = 244) received sham treatment.MAIN OUTCOMES AND MEASURES The key secondary outcome of death or moderate to severe NDD was assessed at 2 years' corrected age. Other secondary outcomes included components of this composite outcome, as well as hospitalizations for respiratory illness and parent-reported wheezing or breathing difficulty in the first 2 years.RESULTS Among the 486 infants randomized, 453 had follow-up data available (median gestation, 27.3 weeks; 228 females [50.3%]); data on the key secondary outcome were available in 434 infants. Death or NDD occurred in 78 infants (36.3%) in the MIST group and 79 (36.1%) in the control group (risk difference, 0%[95% CI, -7.6% to 7.7%]; relative risk [RR], 1.0 [95% CI, 0.81-1.24]); components of this outcome did not differ significantly between groups. Secondary respiratory outcomes favored the MIST group. Hospitalization with respiratory illness occurred in 49 infants (25.1%) in the MIST group vs 78 (38.2%) in the control group (RR, 0.66 [95% CI, 0.54-0.81]) and parent-reported wheezing or breathing difficulty in 73 (40.6%) vs 104 (53.6%), respectively (RR, 0.76 [95% CI, 0.63-0.90]).CONCLUSIONS AND RELEVANCE In this follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome supported with CPAP, MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life.