{
  "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 trialSetting 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": [
    {
      "affiliations": [
        "Division of Neonatology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada",
        "Division of Neonatal Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Souvik Mitra"
    },
    {
      "affiliations": [
        "Division of Neonatology, Department of Pediatrics, Centre hospitalier de l'Université Laval, Quebec City, Quebec, Canada"
      ],
      "name": "Audrey Hebert"
    },
    {
      "affiliations": [
        "Division of Neonatology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Michael P Castaldo"
    },
    {
      "affiliations": [
        "Division of Neonatal Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Tim Disher"
    },
    {
      "affiliations": [
        "Division of Neonatal Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Walid El-Naggar"
    },
    {
      "affiliations": [
        "Division of Cardiology, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Santokh Dhillon"
    },
    {
      "affiliations": [
        "CHOC Children's, Orange, California, USA"
      ],
      "name": "Ziad Alhassen"
    },
    {
      "affiliations": [
        "Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA"
      ],
      "name": "Jenny Koo"
    },
    {
      "affiliations": [
        "Sharp Mary Birch Hospital for Women and Newborns, San Diego, California, USA"
      ],
      "name": "Anup C Katheria"
    },
    {
      "affiliations": [
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Abbas Hyderi"
    },
    {
      "affiliations": [
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Kumar Kumaran"
    },
    {
      "affiliations": [
        "Division of Neonatology, Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada",
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Joseph Ting"
    },
    {
      "affiliations": [
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Aimann Surak"
    },
    {
      "affiliations": [
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Jillian Larocque"
    },
    {
      "affiliations": [
        "Division of Neonatal-Perinatal Care, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Dawn Pepper"
    },
    {
      "affiliations": [
        "Division of Pediatric Cardiology, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Lisa Hornberger"
    },
    {
      "affiliations": [
        "Section of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Oklahoma, Norman, Oklahoma, USA"
      ],
      "name": "Marjorie Makoni"
    },
    {
      "affiliations": [
        "Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Dany E Weisz"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada"
      ],
      "name": "Amish Jain"
    },
    {
      "affiliations": [
        "Canadian Premature Babies Foundation, Toronto, Ontario, Canada"
      ],
      "name": "Fabiana Bacchini"
    },
    {
      "affiliations": [
        "Division of Neonatal Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Austin J J Cameron-Nola"
    },
    {
      "affiliations": [
        "Division of Neonatal Perinatal Medicine, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Tara Hatfield"
    },
    {
      "affiliations": [
        "Child Health Outcomes Research at Leeds, University of Leeds, West Yorkshire, UK"
      ],
      "name": "Jon Dorling"
    },
    {
      "affiliations": [
        "Division of Neonatology, Department of Paediatrics, University of Iowa, Iowa City, Iowa, USA"
      ],
      "name": "Patrick J McNamara"
    },
    {
      "affiliations": [
        "Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Onatrio, Canada",
        "Biostatistics Unit, St Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada",
        "Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa"
      ],
      "name": "Lehana Thabane"
    }
  ],
  "title": "Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial (SMART-PDA)",
  "uid": "afb8e26e-e45c-5d16-88ef-ff437a078f4e"
}