Journal article
Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial (SMART-PDA)
Archives of disease in childhood. Fetal and neonatal edition
05/18/2026
DOI: 10.1136/archdischild-2026-330462
PMID: 42150872
Abstract
ObjectivesTo 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.DesignMulticentre, open-label, parallel-design pilot randomised controlled trialSettingSeven tertiary/quaternary neonatal intensive care units.PatientsInfants <26 weeks gestational age (GA) with a PDA diagnosed within 72 hours after birth.InterventionsParticipants 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 measuresThe primary feasibility outcome was the proportion of eligible infants enrolled. Important secondary outcomes included a composite clinical endpoint of survival without major morbidity.Results116 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.ConclusionsA 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 numberNCT05011149.
Details
- Title: Subtitle
- Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial (SMART-PDA)
- Creators
- Souvik Mitra - University of British ColumbiaAudrey Hebert - CHU de Québec-Université LavalMichael P Castaldo - University of British ColumbiaTim Disher - Izaak Walton Killam Health CentreWalid El-Naggar - Izaak Walton Killam Health CentreSantokh Dhillon - Izaak Walton Killam Health CentreZiad Alhassen - Children's Hospital of Orange CountyJenny Koo - Sharp Mary Birch Hospital for Women & NewbornsAnup C Katheria - Sharp Mary Birch Hospital for Women & NewbornsAbbas Hyderi - University of AlbertaKumar Kumaran - University of AlbertaJoseph Ting - University of British ColumbiaAimann Surak - University of AlbertaJillian Larocque - University of AlbertaDawn Pepper - University of AlbertaLisa Hornberger - University of AlbertaMarjorie Makoni - University of OklahomaDany E Weisz - Sunnybrook Health Science CentreAmish Jain - Mount Sinai HospitalFabiana Bacchini - Canadian Premature Babies Foundation, Toronto, Ontario, CanadaAustin J J Cameron-Nola - Izaak Walton Killam Health CentreTara Hatfield - Izaak Walton Killam Health CentreJon Dorling - University of LeedsPatrick J McNamara - University of IowaLehana Thabane - St. Joseph’s Healthcare Hamilton
- Resource Type
- Journal article
- Publication Details
- Archives of disease in childhood. Fetal and neonatal edition
- DOI
- 10.1136/archdischild-2026-330462
- PMID
- 42150872
- NLM abbreviation
- Arch Dis Child Fetal Neonatal Ed
- ISSN
- 1359-2998
- eISSN
- 1468-2052
- Publisher
- BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
- Grant note
- 1025843 / IWK Health Research; Department of Pediatrics, Dalhousie University 459750 / Canadian Institutes of Health Research (CIHR) 001-A / Dalhousie Medical Research Foundation (http://dx.doi.org/10.13039/100007670)
- Language
- English
- Electronic publication date
- 05/18/2026
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9985164716702771
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