Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial (SMART-PDA)
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVES: To assess feasibility of recruitment and compare clinical outcomes in a trial of early selective treatment of a moderate-severe patent ductus arteriosus (PDA) or no intervention in the first 7 postnatal days in extremely preterm infants. DESIGN: Multicentre, open-label, parallel-design pilot randomised controlled trial SETTING: Seven tertiary/quaternary neonatal intensive care units. PATIENTS: Infants <26 weeks gestational age (GA) with a PDA diagnosed within 72 hours after birth. INTERVENTIONS: Participants were randomised to an early echocardiographic screening within the first 72 hours followed by selective medical treatment (SMART) strategy of a moderate-severe PDA shunt or no intervention in the first 7 days. MAIN OUTCOME MEASURES: The primary feasibility outcome was the proportion of eligible infants enrolled. Important secondary outcomes included a composite clinical endpoint of survival without major morbidity. RESULTS: 116 of 185 eligible infants were enrolled (63%, 95% CI 56% to 70%; SMART, n=51, Control, n=53). Of them, 104/116 (90%) (mean GA 24.3 weeks, birth weight 714 g) were randomised. Protocol deviation was 1.9%. Based on the treatment algorithm, 24% infants randomised to SMART never required treatment. Median treatment initiation age in the SMART arm was 2 days (IQR 1-2.5 days). The SMART strategy demonstrated an 85% probability of a better Win ratio (1.34, 95% CrIs 0.73 to 2.5) compared with control. CONCLUSIONS: A trial of selective early PDA pharmacotherapy based on clinical and echocardiography grading of PDA shunt volume in the smallest infants is feasible with minimal protocol deviation. Early echocardiography screening and selective pharmacotherapy using the SMART-PDA algorithm may enhance the probability of survival with less morbidities in infants born <26 weeks GA. TRIAL REGISTRATION NUMBER: NCT05011149.
Authors: Souvik Mitra, Audrey Hebert, Michael P Castaldo, Tim Disher, Walid El-Naggar, Santokh Dhillon, Ziad Alhassen, Jenny Koo, Anup C Katheria, Abbas Hyderi, Kumar Kumaran, Joseph Ting, Aimann Surak, Jillian Larocque, Dawn Pepper, Lisa Hornberger, Marjorie Makoni, Dany E Weisz, Amish Jain, Fabiana Bacchini, Austin J J Cameron-Nola, Tara Hatfield, Jon Dorling, Patrick J McNamara, Lehana Thabane
Institutions: University of British Columbia, Izaak Walton Killam Health Centre, Centre hospitalier de l'Université Laval, Children's Hospital of Orange County, Sharp Mary Birch Hospital for Women & Newborns, University of Alberta, University of Oklahoma, Sunnybrook Health Science Centre, Mount Sinai Hospital, University of Leeds, University of Iowa, University of Johannesburg, St. Joseph’s Healthcare Hamilton, McMaster University
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Awards: G1360927400, G5030098646
OpenAlex ID: W7161606383